ParkinsonismNCT07322458

The Effect of Spinal Cord Stimulation on Orthostatic Hypotension in Parkinsonism and Its Related Mechanisms

A study testing Epidural spinal cord stimulation and Transcutaneous spinal cord stimulation in people with Parkinsonism, run by Ruijin Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 40 to 80 years
Conditions the study is for: Parkinsonism
What is being tested?: Epidural spinal cord stimulation and Transcutaneous spinal cord stimulation
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteChina
Study dates: 1 Jan 2026to 30 Jun 2028
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

1. Aged between 40 and 80 years;
2. No dementia as measured by the cMMSE scale (formal cMMSE score should be >20 for subjects with 1 to 6 years of formal education; cMMSE score should be >24 for subjects with >6 years of formal education);
3. Able and willing to follow instruction of the researcher;
4. No other conditions that the researchers consider inappropriate for inclusion:

Who cannot join

1. Severe depression (HAMD-17 above 17 as moderate to severe) or anxiety;
2. Pregnancy;
3. History of alcoholism;
4. No skin abnormalities;
5. Non-neurological disease-related symptoms that prevent patients from participation in the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jun LIU, MD, PhD contact

021-64370045

jly0520@hotmail.com

China1 site

Department of Neurology and Institute of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai 200025 Recruiting
Shanghai, Shanghai Municipality
Jun LIU, MD, PhD, 64370045 ext. +86-021, jly0520@hotmail.com

Other trials in China

About this study

Parkinson's disease (PDS) is a syndrome characterized by tremor, bradykinesia, rigidity, and postural disturbances. Causes include Parkinson's disease (PD), multiple system atrophy (MSA), progressive supranuclear palsy (PSP), and corticobasal degeneration (CBD). Non-motor symptoms of PDS, such as neurogenic orthostatic hypotension (nOH), have received more intensive research due to their greater disabling potential compared to motor symptoms. In patients with PD and MSA, nOH can lead to intolerance to medications such as levodopa, significantly increasing the risk of falls, accelerating cognitive decline, and increasing the risk of all-cause mortality. However, conventional pharmacological treatments (such as midodrine, droxidopa, and fludrocortisone) and non-pharmacological approaches (such as compression abdominal bands, elastic stockings, and deep brain stimulation) for non-motor symptoms such as nOH have numerous limitations, including short-term efficacy, uncertain efficacy, and side effects. Therefore, exploring new non-pharmacological treatments to improve nOH and delay disease progression in patients with PDS is crucial for improving their quality of life and prognosis.

Spinal cord stimulation (SCS), including invasive (epidural) spinal cord stimulation (eSCS) and non-invasive (transcutaneous) spinal cord stimulation (tSCS), is a novel neuromodulatory technique with clinical applications in a variety of neurological diseases. Currently, several small-sample studies have suggested the potential efficacy of SCS for nOH caused by spinal cord injury (SCI). This study innovatively proposes the use of eSCS and tSCS to improve nOH and related clinical symptoms in patients with PDS. A prospective, single-center, randomized, controlled clinical trial is planned to compare the efficacy of invasive and non-invasive SCS in treating nOH, thereby providing new insights for the effective treatment of PDS.

Conditions: Parkinsonism
Being tested: Epidural spinal cord stimulation, Transcutaneous spinal cord stimulation
Medical subject headings: Parkinsonian Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Epidural spinal cord stimulationDevice
Epidural spinal cord stimulation (eSCS) is a very thin electrode implanted in the dorsal epidural space of the spinal cord to improve the patient's symptoms by stimulating the spinal nerves with pulsed electrical currents, which attenuate or enhance the flow of nerve impulses from the periphery to the central system, i.e., stimulating thick fibres to achieve therapeutic results. SCS system consists of three components: an electrode implanted in the epidural space of the patient's spinal cord, a stimulator implanted subcutaneously in the abdomen or buttocks that delivers electrical impulses, and an extension cord that connects the two.
Transcutaneous spinal cord stimulationDevice
Transcutaneous spinal cord stimulation (tSCS) is a non-invasive treatment that improves symptoms by stimulating spinal nerves with pulsed electrical currents via electrodes placed at corresponding spinal cord segments. The tSCS system consists of an electrical pulse stimulator, wires, and conductive patches.

Study groups in NCT07322458
Study group	Role	What they receive
Epidural spinal cord stimulation (eSCS) implantation	Experimental	Phase I: (1) Spinal cord segment is selected as the puncture location according to the patient's symptom and the condition of the patient's spinal cord. Percutaneous puncture is performed under X-ray guidance. One or two electrodes are placed in the patient's epidural cavity, and the electrode position is adjusted intraoperatively and by the patient's feedback of the current stimulation position until the current can cover the entire area. (2) An extension lead is connected, an external temporary stimulator is attached, and the patient decides whether to proceed to full implantation in phase II after 7-10 days of phase I testing experience. Phase II: The complete SCS system is implanted under local anesthesia or epidural anesthesia after successful testing. A subcutaneous capsular bag is usually created in the lower abdomen and the implanted electrodes are connected to the pulse generator through a connecting wire in the subcutaneous tunnel. Receives: Device: Epidural spinal cord stimulation
Transcutaneous spinal cord stimulation (tSCS) application	Experimental	After completing the necessary assessments and informed consent procedures, subjects will undergo device installation and seated programming. The cathode of the tSCS device will be placed at the level of the lower thoracic spinal cord via a hydrogel adhesive electrode, and the anode will be placed bilaterally at the iliac crest via a hydrogel adhesive electrode. During seated programming, subjects will undergo continuous non-invasive blood pressure monitoring and a medication-free head-up tilt test (TTT). If subjects demonstrate a satisfactory clinical response during the testing phase (defined as an increase in systolic blood pressure of more than 15-20 mmHg with stimulation on compared to the off state), they will enter regular tSCS therapy during the treatment phase. Receives: Device: Transcutaneous spinal cord stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

Change of blood pressure from baseline to immediately post-operation or post transcutaneous stimulation
Changes of on-off delta systolic and delta diastolic blood pressure from baseline to immediately post-operation or post-stimulation. Delta systolic blood pressure equals the systolic blood pressure of the patient lying minus the systolic blood pressure of the patient standing up for 10 minutes. Delta diastolic blood pressure equals the diastolic blood pressure of the patient lying minus the diastolic blood pressure of the patient standing up for 10 minutes.
Measured: Immediately post surgery or post transcutaneous stimulation
Change of blood pressure from baseline to 3 months post-operation or post transcutaneous stimulation
Changes of on-off delta systolic and delta diastolic blood pressure from baseline to 3 months post-operation or post-stimulation. Delta systolic blood pressure equals the systolic blood pressure of the patient lying minus the systolic blood pressure of the patient standing up for 10 minutes. Delta diastolic blood pressure equals the diastolic blood pressure of the patient lying minus the diastolic blood pressure of the patient standing up for 10 minutes.
Measured: 3 months post surgery or post transcutaneous stimulation
Change of blood pressure from baseline to 6 months post-operation or post transcutaneous stimulation
Changes of on-off delta systolic and delta diastolic blood pressure from baseline to 6 months post-operation or post-stimulation. Delta systolic blood pressure equals the systolic blood pressure of the patient lying minus the systolic blood pressure of the patient standing up for 10 minutes. Delta diastolic blood pressure equals the diastolic blood pressure of the patient lying minus the diastolic blood pressure of the patient standing up for 10 minutes.
Measured: 6 months post surgery or post transcutaneous stimulation
Change of blood pressure from baseline to 9 months post-operation or post transcutaneous stimulation
Changes of on-off delta systolic and delta diastolic blood pressure from baseline to immediately post-operation or post-stimulation. Delta systolic blood pressure equals the systolic blood pressure of the patient lying minus the systolic blood pressure of the patient standing up for 10 minutes. Delta diastolic blood pressure equals the diastolic blood pressure of the patient lying minus the diastolic blood pressure of the patient standing up for 10 minutes.
Measured: 9 months post surgery or post transcutaneous stimulation
Change of blood pressure from baseline to 12 months post-operation or post transcutaneous stimulation
Changes of on-off delta systolic and delta diastolic blood pressure from baseline to 12 months post-operation or post-stimulation. Delta systolic blood pressure equals the systolic blood pressure of the patient lying minus the systolic blood pressure of the patient standing up for 10 minutes. Delta diastolic blood pressure equals the diastolic blood pressure of the patient lying minus the diastolic blood pressure of the patient standing up for 10 minutes.
Measured: 12 months post surgery or post transcutaneous stimulation
Change of blood pressure from baseline to 18 months post-operation or post transcutaneous stimulation
Changes of on-off delta systolic and delta diastolic blood pressure from baseline to 18 months post-operation or post-stimulation. Delta systolic blood pressure equals the systolic blood pressure of the patient lying minus the systolic blood pressure of the patient standing up for 10 minutes. Delta diastolic blood pressure equals the diastolic blood pressure of the patient lying minus the diastolic blood pressure of the patient standing up for 10 minutes.
Measured: 18 months post surgery or post transcutaneous stimulation
Change of blood pressure from baseline to 24 months post-operation or post transcutaneous stimulation
Changes of on-off delta systolic and delta diastolic blood pressure from baseline to 24 months post-operation or post-stimulation. Delta systolic blood pressure equals the systolic blood pressure of the patient lying minus the systolic blood pressure of the patient standing up for 10 minutes. Delta diastolic blood pressure equals the diastolic blood pressure of the patient lying minus the diastolic blood pressure of the patient standing up for 10 minutes.
Measured: 24 months post surgery or post transcutaneous stimulation

Secondary outcomes (140)

Change of oxygen desaturation index from baseline to immediately post-operation or post transcutaneous stimulation
Change of oxygen desaturation index measured by on-off polysomnography from baseline to immediately post-operation or post transcutaneous stimulation
Measured: Immediately post surgery or post transcutaneous stimulation
Change of oxygen desaturation index from baseline to 3 months post-operation or post transcutaneous stimulation
Change of oxygen desaturation index measured by on-off polysomnography from baseline to 3 months post-operation or post transcutaneous stimulation
Measured: 3 months post surgery or post transcutaneous stimulation
Change of oxygen desaturation index from baseline to 6 months post-operation or post transcutaneous stimulation
Change of oxygen desaturation index measured by on-off polysomnography from baseline to 6 months post-operation or post transcutaneous stimulation
Measured: 6 months post surgery or post transcutaneous stimulation
Change of oxygen desaturation index from baseline to 9 months post-operation or post transcutaneous stimulation
Change of oxygen desaturation index measured by on-off polysomnography from baseline to 9 months post-operation or post transcutaneous stimulation
Measured: 9 months post surgery or post transcutaneous stimulation
Change of oxygen desaturation index from baseline to 12 months post-operation or post transcutaneous stimulation
Change of oxygen desaturation index measured by on-off polysomnography from baseline to 12 months post-operation or post transcutaneous stimulation
Measured: 12 months post surgery or post transcutaneous stimulation
Change of oxygen desaturation index from baseline to 18 months post-operation or post transcutaneous stimulation
Change of oxygen desaturation index measured by on-off polysomnography from baseline to 18 months post-operation or post transcutaneous stimulation
Measured: 18 months post surgery or post transcutaneous stimulation
Change of oxygen desaturation index from baseline to 24 months post-operation or post transcutaneous stimulation
Change of oxygen desaturation index measured by on-off polysomnography from baseline to 24 months post-operation or post transcutaneous stimulation
Measured: 24 months post surgery or post transcutaneous stimulation
Change of apnea hypopnea index from baseline to immediately post-operation or post transcutaneous stimulation
Change of apnea hypopnea index measured by on-off polysomnography from baseline to immediately post-operation or post transcutaneous stimulation
Measured: Immediately post surgery or post transcutaneous stimulation
Change of apnea hypopnea index from baseline to 3 months post-operation or post transcutaneous stimulation
Change of apnea hypopnea index measured by on-off polysomnography from baseline to 3 months post-operation or post transcutaneous stimulation
Measured: 3 months post surgery or post transcutaneous stimulation
Change of apnea hypopnea index from baseline to 6 months post-operation or post transcutaneous stimulation
Change of apnea hypopnea index measured by on-off polysomnography from baseline to 6 months post-operation or post transcutaneous stimulation
Measured: 6 months post surgery or post transcutaneous stimulation
Change of apnea hypopnea index from baseline to 9 months post-operation or post transcutaneous stimulation
Change of apnea hypopnea index measured by on-off polysomnography from baseline to 9 months post-operation or post transcutaneous stimulation
Measured: 9 months post surgery or post transcutaneous stimulation
Change of apnea hypopnea index from baseline to 12 months post-operation or post transcutaneous stimulation
Change of apnea hypopnea index measured by on-off polysomnography from baseline to 12 months post-operation or post transcutaneous stimulation
Measured: 12 months post surgery or post transcutaneous stimulation
Change of apnea hypopnea index from baseline to 18 months post-operation or post transcutaneous stimulation
Change of apnea hypopnea index measured by on-off polysomnography from baseline to 18 months post-operation or post transcutaneous stimulation
Measured: 18 months post surgery or post transcutaneous stimulation
Change of apnea hypopnea index from baseline to 24 months post-operation or post transcutaneous stimulation
Change of apnea hypopnea index measured by on-off polysomnography from baseline to 24 months post-operation or post transcutaneous stimulation
Measured: 24 months post surgery or post transcutaneous stimulation
Change of on-off 24-hour blood pressure monitoring from baseline to immediately post-operation or post transcutaneous stimulation
Change of on-off 24-hour blood pressure monitoring from baseline to immediately post-operation or post transcutaneous stimulation
Measured: Immediately post surgery or post transcutaneous stimulation
Change of on-off 24-hour blood pressure monitoring from baseline to 3 months post-operation or post transcutaneous stimulation
Change of on-off 24-hour blood pressure monitoring from baseline to 3 months post-operation or post transcutaneous stimulation
Measured: 3 months post surgery or post transcutaneous stimulation
Change of on-off 24-hour blood pressure monitoring from baseline to 6 months post-operation or post transcutaneous stimulation
Change of on-off 24-hour blood pressure monitoring from baseline to 6 months post-operation or post transcutaneous stimulation
Measured: 6 months post surgery or post transcutaneous stimulation
Change of on-off 24-hour blood pressure monitoring from baseline to 9 months post-operation or post transcutaneous stimulation
Change of on-off 24-hour blood pressure monitoring from baseline to 9 months post-operation or post transcutaneous stimulation
Measured: 9 months post surgery or post transcutaneous stimulation
Change of on-off 24-hour blood pressure monitoring from baseline to 12 months post-operation or post transcutaneous stimulation
Change of on-off 24-hour blood pressure monitoring from baseline to 12 months post-operation or post transcutaneous stimulation
Measured: 12 months post surgery or post transcutaneous stimulation
Change of on-off 24-hour blood pressure monitoring from baseline to 18 months post-operation or post transcutaneous stimulation
Change of on-off 24-hour blood pressure monitoring from baseline to 18 months post-operation or post transcutaneous stimulation
Measured: 18 months post surgery or post transcutaneous stimulation
Change of on-off 24-hour blood pressure monitoring from baseline to 24 months post-operation or post transcutaneous stimulation
Change of on-off 24-hour blood pressure monitoring from baseline to 24 months post-operation or post transcutaneous stimulation
Measured: 24 months post surgery or post transcutaneous stimulation
Change of on-off time patient spend in supine status, seated status, standing/walking status from baseline to immediately post-operation or post transcutaneous stimulation
Change of on-off time patient spend in supine status, seated status, standing/walking status from baseline to immediately post-operation or post transcutaneous stimulation
Measured: Immediately post surgery or post transcutaneous stimulation
Change of on-off time patient spend in supine status, seated status, standing/walking status from baseline to 3 months post-operation or post transcutaneous stimulation
Change of on-off time patient spend in supine status, seated status, standing/walking status from baseline to 3 months post-operation or post transcutaneous stimulation
Measured: 3 months post surgery or post transcutaneous stimulation
Change of on-off time patient spend in supine status, seated status, standing/walking status from baseline to 6 months post-operation or post transcutaneous stimulation
Change of on-off time patient spend in supine status, seated status, standing/walking status from baseline to 6 months post-operation or post transcutaneous stimulation
Measured: 6 months post surgery or post transcutaneous stimulation
Change of on-off time patient spend in supine status, seated status, standing/walking status from baseline to 9 months post-operation or post transcutaneous stimulation
Change of on-off time patient spend in supine status, seated status, standing/walking status from baseline to 9 months post-operation or post transcutaneous stimulation
Measured: 9 months post surgery or post transcutaneous stimulation
Change of on-off time patient spend in supine status, seated status, standing/walking status from baseline to 12 months post-operation or post transcutaneous stimulation
Change of on-off time patient spend in supine status, seated status, standing/walking status from baseline to 12 months post-operation or post transcutaneous stimulation
Measured: 12 months post surgery or post transcutaneous stimulation
Change of on-off time patient spend in supine status, seated status, standing/walking status from baseline to 18 months post-operation or post transcutaneous stimulation
Change of on-off time patient spend in supine status, seated status, standing/walking status from baseline to 18 months post-operation or post transcutaneous stimulation
Measured: 18 months post surgery or post transcutaneous stimulation
Change of on-off time patient spend in supine status, seated status, standing/walking status from baseline to 24 months post-operation or post transcutaneous stimulation
Change of on-off time patient spend in supine status, seated status, standing/walking status from baseline to 24 months post-operation or post transcutaneous stimulation
Measured: 24 months post surgery or post transcutaneous stimulation
Change of serum catecholamine neurotransmitter levels from baseline to immediately post-operation or post transcutaneous stimulation
Change of on-off delta serum catecholamine neurotransmitter levels from baseline to immediately post-operation or post transcutaneous stimulation. Delta serum catecholamine neurotransmitter levels equals the serum catecholamine neurotransmitter levels of the patient lying minus the serum catecholamine neurotransmitter levels of the patient standing up for 10 minutes.
Measured: Immediately post surgery or post transcutaneous stimulation
Change of serum catecholamine neurotransmitter levels from baseline to 3 months post-operation or post transcutaneous stimulation
Change of on-off delta serum catecholamine neurotransmitter levels from baseline to 3 months post-operation or post transcutaneous stimulation. Delta serum catecholamine neurotransmitter levels equals the serum catecholamine neurotransmitter levels of the patient lying minus the serum catecholamine neurotransmitter levels of the patient standing up for 10 minutes.
Measured: 3 months post surgery or post transcutaneous stimulation
Change of serum catecholamine neurotransmitter levels from baseline to 6 months post-operation or post transcutaneous stimulation
Change of on-off delta serum catecholamine neurotransmitter levels from baseline to 6 months post-operation or post transcutaneous stimulation. Delta serum catecholamine neurotransmitter levels equals the serum catecholamine neurotransmitter levels of the patient lying minus the serum catecholamine neurotransmitter levels of the patient standing up for 10 minutes.
Measured: 6 months post surgery or post transcutaneous stimulation
Change of serum catecholamine neurotransmitter levels from baseline to 9 months post-operation or post transcutaneous stimulation
Change of on-off delta serum catecholamine neurotransmitter levels from baseline to 9 months post-operation or post transcutaneous stimulation. Delta serum catecholamine neurotransmitter levels equals the serum catecholamine neurotransmitter levels of the patient lying minus the serum catecholamine neurotransmitter levels of the patient standing up for 10 minutes.
Measured: 9 months post surgery or post transcutaneous stimulation
Change of serum catecholamine neurotransmitter levels from baseline to 12 months post-operation or post transcutaneous stimulation
Change of on-off delta serum catecholamine neurotransmitter levels from baseline to 12 months post-operation or post transcutaneous stimulation. Delta serum catecholamine neurotransmitter levels equals the serum catecholamine neurotransmitter levels of the patient lying minus the serum catecholamine neurotransmitter levels of the patient standing up for 10 minutes.
Measured: 12 months post surgery or post transcutaneous stimulation
Change of serum catecholamine neurotransmitter levels from baseline to 18 months post-operation or post transcutaneous stimulation
Change of on-off delta serum catecholamine neurotransmitter levels from baseline to 18 months post-operation or post transcutaneous stimulation. Delta serum catecholamine neurotransmitter levels equals the serum catecholamine neurotransmitter levels of the patient lying minus the serum catecholamine neurotransmitter levels of the patient standing up for 10 minutes.
Measured: 18 months post surgery or post transcutaneous stimulation
Change of serum catecholamine neurotransmitter levels from baseline to 24 months post-operation or post transcutaneous stimulation
Change of on-off delta serum catecholamine neurotransmitter levels from baseline to 24 months post-operation or post transcutaneous stimulation. Delta serum catecholamine neurotransmitter levels equals the serum catecholamine neurotransmitter levels of the patient lying minus the serum catecholamine neurotransmitter levels of the patient standing up for 10 minutes.
Measured: 24 months post surgery or post transcutaneous stimulation
Change of on-off delta heart rate variability from baseline to immediately post-operation or post transcutaneous stimulation
Change of on-off delta heart rate variability from baseline to immediately post-operation or post transcutaneous stimulation. Delta heart rate variability equals the heart rate variability of the patient lying minus the heart rate variability of the patient standing up for 10 minutes.
Measured: Immediately post surgery or post transcutaneous stimulation
Change of on-off delta heart rate variability from baseline to 3 months post-operation or post transcutaneous stimulation
Change of on-off delta heart rate variability from baseline to 3 months post-operation or post transcutaneous stimulation. Delta heart rate variability equals the heart rate variability of the patient lying minus the heart rate variability of the patient standing up for 10 minutes.
Measured: 3 months post surgery or post transcutaneous stimulation
Change of on-off delta heart rate variability from baseline to 6 months post-operation or post transcutaneous stimulation
Change of on-off delta heart rate variability from baseline to 6 months post-operation or post transcutaneous stimulation. Delta heart rate variability equals the heart rate variability of the patient lying minus the heart rate variability of the patient standing up for 10 minutes.
Measured: 6 months post surgery or post transcutaneous stimulation
Change of on-off delta heart rate variability from baseline to 9 months post-operation or post transcutaneous stimulation
Change of on-off delta heart rate variability from baseline to 9 months post-operation or post transcutaneous stimulation. Delta heart rate variability equals the heart rate variability of the patient lying minus the heart rate variability of the patient standing up for 10 minutes.
Measured: 9 months post surgery or post transcutaneous stimulation
Change of on-off delta heart rate variability from baseline to 12 months post-operation or post transcutaneous stimulation
Change of on-off delta heart rate variability from baseline to 12 months post-operation or post transcutaneous stimulation. Delta heart rate variability equals the heart rate variability of the patient lying minus the heart rate variability of the patient standing up for 10 minutes.
Measured: 12 months post surgery or post transcutaneous stimulation
Change of on-off delta heart rate variability from baseline to 18 months post-operation or post transcutaneous stimulation
Change of on-off delta heart rate variability from baseline to 18 months post-operation or post transcutaneous stimulation. Delta heart rate variability equals the heart rate variability of the patient lying minus the heart rate variability of the patient standing up for 10 minutes.
Measured: 18 months post surgery or post transcutaneous stimulation
Change of on-off delta heart rate variability from baseline to 24 months post-operation or post transcutaneous stimulation
Change of on-off delta heart rate variability from baseline to 24 months post-operation or post transcutaneous stimulation. Delta heart rate variability equals the heart rate variability of the patient lying minus the heart rate variability of the patient standing up for 10 minutes.
Measured: 24 months post surgery or post transcutaneous stimulation
Change of length of walking during 6-minute walking test from baseline to immediately post-operation or post transcutaneous stimulation
Change of on-off length of walking during 6-minute walking test from baseline to immediately post-operation or post transcutaneous stimulation
Measured: Immediately post surgery or post transcutaneous stimulation
Change of length of walking during 6-minute walking test from baseline to 3 months post-operation or post transcutaneous stimulation
Change of on-off length of walking during 6-minute walking test from baseline to 3 months post-operation or post transcutaneous stimulation
Measured: 3 months post surgery or post transcutaneous stimulation
Change of length of walking during 6-minute walking test from baseline to 6 months post-operation or post transcutaneous stimulation
Change of on-off length of walking during 6-minute walking test from baseline to 6 months post-operation or post transcutaneous stimulation
Measured: 6 months post surgery or post transcutaneous stimulation
Change of length of walking during 6-minute walking test from baseline to 9 months post-operation or post transcutaneous stimulation
Change of on-off length of walking during 6-minute walking test from baseline to 9 months post-operation or post transcutaneous stimulation
Measured: 9 months post surgery or post transcutaneous stimulation
Change of length of walking during 6-minute walking test from baseline to 12 months post-operation or post transcutaneous stimulation
Change of on-off length of walking during 6-minute walking test from baseline to 12 months post-operation or post transcutaneous stimulation
Measured: 12 months post surgery or post transcutaneous stimulation
Change of length of walking during 6-minute walking test from baseline to 18 months post-operation or post transcutaneous stimulation
Change of on-off length of walking during 6-minute walking test from baseline to 18 months post-operation or post transcutaneous stimulation
Measured: 18 months post surgery or post transcutaneous stimulation
Change of length of walking during 6-minute walking test from baseline to 24 months post-operation or post transcutaneous stimulation
Change of on-off length of walking during 6-minute walking test from baseline to 24 months post-operation or post transcutaneous stimulation
Measured: 24 months post surgery or post transcutaneous stimulation
Change of time of walking during 6-minute walking test from baseline to immediately post-operation or post transcutaneous stimulation
Change of on-off time of walking during 6-minute walking test from baseline to immediately post-operation or post transcutaneous stimulation
Measured: Immediately post surgery or post transcutaneous stimulation
Change of time of walking during 6-minute walking test from baseline to 3 months post-operation or post transcutaneous stimulation
Change of on-off time of walking during 6-minute walking test from baseline to 3 months post-operation or post transcutaneous stimulation
Measured: 3 months post surgery or post transcutaneous stimulation
Change of time of walking during 6-minute walking test from baseline to 6 months post-operation or post transcutaneous stimulation
Change of on-off time of walking during 6-minute walking test from baseline to 6 months post-operation or post transcutaneous stimulation
Measured: 6 months post surgery or post transcutaneous stimulation
Change of time of walking during 6-minute walking test from baseline to 9 months post-operation or post transcutaneous stimulation
Change of on-off time of walking during 6-minute walking test from baseline to 9 months post-operation or post transcutaneous stimulation
Measured: 9 months post surgery or post transcutaneous stimulation
Change of time of walking during 6-minute walking test from baseline to 12 months post-operation or post transcutaneous stimulation
Change of on-off time of walking during 6-minute walking test from baseline to 12 months post-operation or post transcutaneous stimulation
Measured: 12 months post surgery or post transcutaneous stimulation
Change of time of walking during 6-minute walking test from baseline to 18 months post-operation or post transcutaneous stimulation
Change of on-off time of walking during 6-minute walking test from baseline to 18 months post-operation or post transcutaneous stimulation
Measured: 18 months post surgery or post transcutaneous stimulation
Change of time of walking during 6-minute walking test from baseline to 24 months post-operation or post transcutaneous stimulation
Change of on-off time of walking during 6-minute walking test from baseline to 24 months post-operation or post transcutaneous stimulation
Measured: 24 months post surgery or post transcutaneous stimulation
Change of on-off numbers of mistakes made during Stroop Color and Word Test from baseline to immediately post-operation or post transcutaneous stimulation
Change of on-off numbers of mistakes made during Stroop Color and Word Test from baseline to immediately post-operation or post transcutaneous stimulation
Measured: Immediately post surgery or post transcutaneous stimulation
Change of on-off numbers of mistakes made during Stroop Color and Word Test from baseline to 3 months post-operation or post transcutaneous stimulation
Change of on-off numbers of mistakes made during Stroop Color and Word Test from baseline to 3 months post-operation or post transcutaneous stimulation
Measured: 3 months post surgery or post transcutaneous stimulation
Change of on-off numbers of mistakes made during Stroop Color and Word Test from baseline to 6 months post-operation or post transcutaneous stimulation
Change of on-off numbers of mistakes made during Stroop Color and Word Test from baseline to 6 months post-operation or post transcutaneous stimulation
Measured: 6 months post surgery or post transcutaneous stimulation
Change of on-off numbers of mistakes made during Stroop Color and Word Test from baseline to 9 months post-operation or post transcutaneous stimulation
Change of on-off numbers of mistakes made during Stroop Color and Word Test from baseline to 9 months post-operation or post transcutaneous stimulation
Measured: 9 months post surgery or post transcutaneous stimulation
Change of on-off numbers of mistakes made during Stroop Color and Word Test from baseline to 12 months post-operation or post transcutaneous stimulation
Change of on-off numbers of mistakes made during Stroop Color and Word Test from baseline to 12 months post-operation or post transcutaneous stimulation
Measured: 12 months post surgery or post transcutaneous stimulation
Change of on-off numbers of mistakes made during Stroop Color and Word Test from baseline to 18 months post-operation or post transcutaneous stimulation
Change of on-off numbers of mistakes made during Stroop Color and Word Test from baseline to 18 months post-operation or post transcutaneous stimulation
Measured: 18 months post surgery or post transcutaneous stimulation
Change of on-off numbers of mistakes made during Stroop Color and Word Test from baseline to 24 months post-operation or post transcutaneous stimulation
Change of on-off numbers of mistakes made during Stroop Color and Word Test from baseline to 24 months post-operation or post transcutaneous stimulation
Measured: 24 months post surgery or post transcutaneous stimulation
Change of on-off time to complete the Stroop Color and Word Test from baseline to immediately post-operation or post transcutaneous stimulation
Change of on-off time to complete the Stroop Color and Word Test from baseline to immediately post-operation or post transcutaneous stimulation
Measured: Immediately post surgery or post transcutaneous stimulation
Change of on-off time to complete the Stroop Color and Word Test from baseline to 3 months post-operation or post transcutaneous stimulation
Change of on-off time to complete the Stroop Color and Word Test from baseline to 3 months post-operation or post transcutaneous stimulation
Measured: 3 months post surgery or post transcutaneous stimulation
Change of on-off time to complete the Stroop Color and Word Test from baseline to 6 months post-operation or post transcutaneous stimulation
Change of on-off time to complete the Stroop Color and Word Test from baseline to 6 months post-operation or post transcutaneous stimulation
Measured: 6 months post surgery or post transcutaneous stimulation
Change of on-off time to complete the Stroop Color and Word Test from baseline to 9 months post-operation or post transcutaneous stimulation
Change of on-off time to complete the Stroop Color and Word Test from baseline to 9 months post-operation or post transcutaneous stimulation
Measured: 9 months post surgery or post transcutaneous stimulation
Change of on-off time to complete the Stroop Color and Word Test from baseline to 12 months post-operation or post transcutaneous stimulation
Change of on-off time to complete the Stroop Color and Word Test from baseline to 12 months post-operation or post transcutaneous stimulation
Measured: 12 months post surgery or post transcutaneous stimulation
Change of on-off time to complete the Stroop Color and Word Test from baseline to 18 months post-operation or post transcutaneous stimulation
Change of on-off time to complete the Stroop Color and Word Test from baseline to 18 months post-operation or post transcutaneous stimulation
Measured: 18 months post surgery or post transcutaneous stimulation
Change of on-off time to complete the Stroop Color and Word Test from baseline to 24 months post-operation or post transcutaneous stimulation
Change of on-off time to complete the Stroop Color and Word Test from baseline to 24 months post-operation or post transcutaneous stimulation
Measured: 24 months post surgery or post transcutaneous stimulation
Change of on-off delta brain cortex oxygenated hemoglobin levels from baseline to immediately post-operation or post transcutaneous stimulation
Change of on-off delta brain cortex oxygenated hemoglobin levels from baseline to immediately post-operation or post transcutaneous stimulation. Delta brain cortex oxygenated hemoglobin levels equals the brain cortex oxygenated hemoglobin levels of the patient lying minus the brain cortex oxygenated hemoglobin levels of the patient standing up for 10 minutes.
Measured: Immediately post surgery or post transcutaneous stimulation
Change of on-off delta brain cortex oxygenated hemoglobin levels from baseline to 3 months post-operation or post transcutaneous stimulation
Change of on-off delta brain cortex oxygenated hemoglobin levels from baseline to 3 months post-operation or post transcutaneous stimulation. Delta brain cortex oxygenated hemoglobin levels equals the brain cortex oxygenated hemoglobin levels of the patient lying minus the brain cortex oxygenated hemoglobin levels of the patient standing up for 10 minutes.
Measured: 3 months post surgery or post transcutaneous stimulation
Change of on-off delta brain cortex oxygenated hemoglobin levels from baseline to 6 months post-operation or post transcutaneous stimulation
Change of on-off delta brain cortex oxygenated hemoglobin levels from baseline to 6 months post-operation or post transcutaneous stimulation. Delta brain cortex oxygenated hemoglobin levels equals the brain cortex oxygenated hemoglobin levels of the patient lying minus the brain cortex oxygenated hemoglobin levels of the patient standing up for 10 minutes.
Measured: 6 months post surgery or post transcutaneous stimulation
Change of on-off delta brain cortex oxygenated hemoglobin levels from baseline to 9 months post-operation or post transcutaneous stimulation
Change of on-off delta brain cortex oxygenated hemoglobin levels from baseline to 9 months post-operation or post transcutaneous stimulation. Delta brain cortex oxygenated hemoglobin levels equals the brain cortex oxygenated hemoglobin levels of the patient lying minus the brain cortex oxygenated hemoglobin levels of the patient standing up for 10 minutes.
Measured: 9 months post surgery or post transcutaneous stimulation
Change of on-off delta brain cortex oxygenated hemoglobin levels from baseline to 12 months post-operation or post transcutaneous stimulation
Change of on-off delta brain cortex oxygenated hemoglobin levels from baseline to 12 months post-operation or post transcutaneous stimulation. Delta brain cortex oxygenated hemoglobin levels equals the brain cortex oxygenated hemoglobin levels of the patient lying minus the brain cortex oxygenated hemoglobin levels of the patient standing up for 10 minutes.
Measured: 12 months post surgery or post transcutaneous stimulation
Change of on-off delta brain cortex oxygenated hemoglobin levels from baseline to 18 months post-operation or post transcutaneous stimulation
Change of on-off delta brain cortex oxygenated hemoglobin levels from baseline to 18 months post-operation or post transcutaneous stimulation. Delta brain cortex oxygenated hemoglobin levels equals the brain cortex oxygenated hemoglobin levels of the patient lying minus the brain cortex oxygenated hemoglobin levels of the patient standing up for 10 minutes.
Measured: 18 months post surgery or post transcutaneous stimulation
Change of on-off delta brain cortex oxygenated hemoglobin levels from baseline to 24 months post-operation or post transcutaneous stimulation
Change of on-off delta brain cortex oxygenated hemoglobin levels from baseline to 24 months post-operation or post transcutaneous stimulation. Delta brain cortex oxygenated hemoglobin levels equals the brain cortex oxygenated hemoglobin levels of the patient lying minus the brain cortex oxygenated hemoglobin levels of the patient standing up for 10 minutes.
Measured: 24 months post surgery or post transcutaneous stimulation
Change of dysarthria symptom from baseline to immediately post-operation or post transcutaneous stimulation
Change of dysarthria symptom measured by on-off Dysphonia Severity Index of Atoms Speech Assessment System from baseline to immediately post-operation or post transcutaneous stimulation
Measured: Immediately post surgery or post transcutaneous stimulation
Change of dysarthria symptom from baseline to 3 months post-operation or post transcutaneous stimulation
Change of dysarthria symptom measured by on-off Dysphonia Severity Index of Atoms Speech Assessment System from baseline to 3 months post-operation or post transcutaneous stimulation
Measured: 3 months post surgery or post transcutaneous stimulation
Change of dysarthria symptom from baseline to 6 months post-operation or post transcutaneous stimulation
Change of dysarthria symptom measured by on-off Dysphonia Severity Index of Atoms Speech Assessment System from baseline to 6 months post-operation or post transcutaneous stimulation
Measured: 6 months post surgery or post transcutaneous stimulation
Change of dysarthria symptom from baseline to 9 months post-operation or post transcutaneous stimulation
Change of dysarthria symptom measured by on-off Dysphonia Severity Index of Atoms Speech Assessment System from baseline to 9 months post-operation or post transcutaneous stimulation
Measured: 9 months post surgery or post transcutaneous stimulation
Change of dysarthria symptom from baseline to 12 months post-operation or post transcutaneous stimulation
Change of dysarthria symptom measured by on-off Dysphonia Severity Index of Atoms Speech Assessment System from baseline to 12 months post-operation or post transcutaneous stimulation
Measured: 12 months post surgery or post transcutaneous stimulation
Change of dysarthria symptom from baseline to 18 months post-operation or post transcutaneous stimulation
Change of dysarthria symptom measured by on-off Dysphonia Severity Index of Atoms Speech Assessment System from baseline to 18 months post-operation or post transcutaneous stimulation
Measured: 18 months post surgery or post transcutaneous stimulation
Change of dysarthria symptom from baseline to 24 months post-operation or post transcutaneous stimulation
Change of dysarthria symptom measured by on-off Dysphonia Severity Index of Atoms Speech Assessment System from baseline to 24 months post-operation or post transcutaneous stimulation
Measured: 24 months post surgery or post transcutaneous stimulation
Change of urinary retention from baseline to immediately post-operation or post transcutaneous stimulation
The change of volume of urinary retention measured by ultrasound and urodynamic study from baseline to immediately post-operation or post transcutaneous stimulation
Measured: Immediately post surgery or post transcutaneous stimulation
Change of urinary retention from baseline to 3 months post-operation or post transcutaneous stimulation
The change of volume of urinary retention measured by ultrasound and urodynamic study from baseline to 3 months post-operation or post transcutaneous stimulation
Measured: 3 months post surgery or post transcutaneous stimulation
Change of urinary retention from baseline to 6 months post-operation or post transcutaneous stimulation
The change of volume of urinary retention measured by ultrasound and urodynamic study from baseline to 6 months post-operation or post transcutaneous stimulation
Measured: 6 months post surgery or post transcutaneous stimulation
Change of urinary retention from baseline to 9 months post-operation or post transcutaneous stimulation
The change of volume of urinary retention measured by ultrasound and urodynamic study from baseline to 9 months post-operation or post transcutaneous stimulation
Measured: 9 months post surgery or post transcutaneous stimulation
Change of urinary retention from baseline to 12 months post-operation or post transcutaneous stimulation
The change of volume of urinary retention measured by ultrasound and urodynamic study from baseline to 12 months post-operation or post transcutaneous stimulation
Measured: 12 months post surgery or post transcutaneous stimulation
Change of urinary retention from baseline to 18 months post-operation or post transcutaneous stimulation
The change of volume of urinary retention measured by ultrasound and urodynamic study from baseline to 18 months post-operation or post transcutaneous stimulation
Measured: 18 months post surgery or post transcutaneous stimulation
Change of urinary retention from baseline to 24 months post-operation or post transcutaneous stimulation
The change of volume of urinary retention measured by ultrasound and urodynamic study from baseline to 24 months post-operation or post transcutaneous stimulation
Measured: 24 months post surgery or post transcutaneous stimulation
Change of MDS-UPDRS from baseline to immediately post-operation or post transcutaneous stimulation
The change of on-off rating of the Movement Disorders Society sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) from baseline to immediately post-operation or post transcutaneous stimulation
Measured: Immediately post surgery or post transcutaneous stimulation
Change of MDS-UPDRS from baseline to 3 months post-operation or post transcutaneous stimulation
The change of on-off rating of the Movement Disorders Society sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) from baseline to 3 months post-operation or post transcutaneous stimulation
Measured: 3 months post surgery or post transcutaneous stimulation
Change of MDS-UPDRS from baseline to 6 months post-operation or post transcutaneous stimulation
The change of on-off rating of the Movement Disorders Society sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) from baseline to 6 months post-operation or post transcutaneous stimulation
Measured: 6 months post surgery or post transcutaneous stimulation
Change of MDS-UPDRS from baseline to 9 months post-operation or post transcutaneous stimulation
The change of on-off rating of the Movement Disorders Society sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) from baseline to 9 months post-operation or post transcutaneous stimulation
Measured: 9 months post surgery or post transcutaneous stimulation
Change of MDS-UPDRS from baseline to 12 months post-operation or post transcutaneous stimulation
The change of on-off rating of the Movement Disorders Society sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) from baseline to 12 months post-operation or post transcutaneous stimulation
Measured: 12 months post surgery or post transcutaneous stimulation
Change of MDS-UPDRS from baseline to 18 months post-operation or post transcutaneous stimulation
The change of on-off rating of the Movement Disorders Society sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) from baseline to 18 months post-operation or post transcutaneous stimulation
Measured: 18 months post surgery or post transcutaneous stimulation
Change of MDS-UPDRS from baseline to 24 months post-operation or post transcutaneous stimulation
The change of on-off rating of the Movement Disorders Society sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) from baseline to 24 months post-operation or post transcutaneous stimulation
Measured: 24 months post surgery or post transcutaneous stimulation
Change of UMSARS from baseline to 3 months post-operation or post transcutaneous stimulation
The change of on- off rating of the Unified Multiple System Atrophy Rating Scale (UMSARS) from baseline to 3 months post-operation or post transcutaneous stimulation
Measured: 3 months post surgery or post transcutaneous stimulation
Change of UMSARS from baseline to 6 months post-operation or post transcutaneous stimulation
The change of on- off rating of the Unified Multiple System Atrophy Rating Scale (UMSARS) from baseline to 6 months post-operation or post transcutaneous stimulation
Measured: 6 months post surgery or post transcutaneous stimulation
Change of UMSARS from baseline to 9 months post-operation or post transcutaneous stimulation
The change of on- off rating of the Unified Multiple System Atrophy Rating Scale (UMSARS) from baseline to 9 months post-operation or post transcutaneous stimulation
Measured: 9 months post surgery or post transcutaneous stimulation
Change of UMSARS from baseline to 12 months post-operation or post transcutaneous stimulation
The change of on- off rating of the Unified Multiple System Atrophy Rating Scale (UMSARS) from baseline to 12 months post-operation or post transcutaneous stimulation
Measured: 12 months post surgery or post transcutaneous stimulation
Change of UMSARS from baseline to 18 months post-operation or post transcutaneous stimulation
The change of on- off rating of the Unified Multiple System Atrophy Rating Scale (UMSARS) from baseline to 18 months post-operation or post transcutaneous stimulation
Measured: 18 months post surgery or post transcutaneous stimulation
Change of UMSARS from baseline to 24 months post-operation or post transcutaneous stimulation
The change of on- off rating of the Unified Multiple System Atrophy Rating Scale (UMSARS) from baseline to 24 months post-operation or post transcutaneous stimulation
Measured: 24 months post surgery or post transcutaneous stimulation
Change of UMSARS from baseline to immediately post-operation or post transcutaneous stimulation
The change of on- off rating of the Unified Multiple System Atrophy Rating Scale (UMSARS) from baseline to immediately post-operation or post transcutaneous stimulation
Measured: Immediately post surgery or post transcutaneous stimulation
Change of lowest oxygen saturation from baseline to immediately post-operation or post transcutaneous stimulation
Change of lowest oxygen saturation measured by on-off polysomnography from baseline to immediately post-operation or post transcutaneous stimulation
Measured: Immediately post surgery or post transcutaneous stimulation
Change of lowest oxygen saturation from baseline to 3 months post-operation or post transcutaneous stimulation
Change of lowest oxygen saturation measured by on-off polysomnography from baseline to 3 months post-operation or post transcutaneous stimulation
Measured: 3 months post surgery or post transcutaneous stimulation
Change of lowest oxygen saturation from baseline to 6 months post-operation or post transcutaneous stimulation
Change of lowest oxygen saturation measured by on-off polysomnography from baseline to 6 months post-operation or post transcutaneous stimulation
Measured: 6 months post surgery or post transcutaneous stimulation
Change of lowest oxygen saturation from baseline to 9 months post-operation or post transcutaneous stimulation
Change of lowest oxygen saturation measured by on-off polysomnography from baseline to 9 months post-operation or post transcutaneous stimulation
Measured: 9 months post surgery or post transcutaneous stimulation
Change of lowest oxygen saturation from baseline to 12 months post-operation or post transcutaneous stimulation
Change of lowest oxygen saturation measured by on-off polysomnography from baseline to 12 months post-operation or post transcutaneous stimulation
Measured: 12 months post surgery or post transcutaneous stimulation
Change of lowest oxygen saturation from baseline to 18 months post-operation or post transcutaneous stimulation
Change of lowest oxygen saturation measured by on-off polysomnography from baseline to 18 months post-operation or post transcutaneous stimulation
Measured: 18 months post surgery or post transcutaneous stimulation
Change of lowest oxygen saturation from baseline to 24 months post-operation or post transcutaneous stimulation
Change of lowest oxygen saturation measured by on-off polysomnography from baseline to 24 months post-operation or post transcutaneous stimulation
Measured: 24 months post surgery or post transcutaneous stimulation
Change of mean oxygen saturation from baseline to immediately post-operation or post transcutaneous stimulation
Change of mean oxygen saturation measured by on-off polysomnography from baseline to immediately post-operation or post transcutaneous stimulation
Measured: Immediately post surgery or post transcutaneous stimulation
Change of mean oxygen saturation from baseline to 3 months post-operation or post transcutaneous stimulation
Change of mean oxygen saturation measured by on-off polysomnography from baseline to 3 months post-operation or post transcutaneous stimulation
Measured: 3 months post surgery or post transcutaneous stimulation
Change of mean oxygen saturation from baseline to 6 months post-operation or post transcutaneous stimulation
Change of mean oxygen saturation measured by on-off polysomnography from baseline to 6 months post-operation or post transcutaneous stimulation
Measured: 6 months post surgery or post transcutaneous stimulation
Change of mean oxygen saturation from baseline to 9 months post-operation or post transcutaneous stimulation
Change of mean oxygen saturation measured by on-off polysomnography from baseline to 9 months post-operation or post transcutaneous stimulation
Measured: 9 months post surgery or post transcutaneous stimulation
Change of mean oxygen saturation from baseline to 12 months post-operation or post transcutaneous stimulation
Change of mean oxygen saturation measured by on-off polysomnography from baseline to 12 months post-operation or post transcutaneous stimulation
Measured: 12 months post surgery or post transcutaneous stimulation
Change of mean oxygen saturation from baseline to 18 months post-operation or post transcutaneous stimulation
Change of mean oxygen saturation measured by on-off polysomnography from baseline to 18 months post-operation or post transcutaneous stimulation
Measured: 18 months post surgery or post transcutaneous stimulation
Change of mean oxygen saturation from baseline to 24 months post-operation or post transcutaneous stimulation
Change of mean oxygen saturation measured by on-off polysomnography from baseline to 24 months post-operation or post transcutaneous stimulation
Measured: 24 months post surgery or post transcutaneous stimulation
Change of SCOPA-AUT from baseline to immediately post-operation or post transcutaneous stimulation
Change of scales for outcomes in Parkinson's disease - autonomic dysfunction from baseline to immediately post-operation or post transcutaneous stimulation
Measured: Immediately post surgery or post transcutaneous stimulation
Change of SCOPA-AUT from baseline to 3 months post-operation or post transcutaneous stimulation
Change of scales for outcomes in Parkinson's disease - autonomic dysfunction from baseline to 3 months post-operation or post transcutaneous stimulation
Measured: 3 months post surgery or post transcutaneous stimulation
Change of SCOPA-AUT from baseline to 6 months post-operation or post transcutaneous stimulation
Change of scales for outcomes in Parkinson's disease - autonomic dysfunction from baseline to 6 months post-operation or post transcutaneous stimulation
Measured: 6 months post surgery or post transcutaneous stimulation
Change of SCOPA-AUT from baseline to 9 months post-operation or post transcutaneous stimulation
Change of scales for outcomes in Parkinson's disease - autonomic dysfunction from baseline to 9 months post-operation or post transcutaneous stimulation
Measured: 9 months post surgery or post transcutaneous stimulation
Change of SCOPA-AUT from baseline to 12 months post-operation or post transcutaneous stimulation
Change of scales for outcomes in Parkinson's disease - autonomic dysfunction from baseline to 12 months post-operation or post transcutaneous stimulation
Measured: 12 months post surgery or post transcutaneous stimulation
Change of SCOPA-AUT from baseline to 18 months post-operation or post transcutaneous stimulation
Change of scales for outcomes in Parkinson's disease - autonomic dysfunction from baseline to 18 months post-operation or post transcutaneous stimulation
Measured: 18 months post surgery or post transcutaneous stimulation
Change of SCOPA-AUT from baseline to 24 months post-operation or post transcutaneous stimulation
Change of scales for outcomes in Parkinson's disease - autonomic dysfunction from baseline to 24 months post-operation or post transcutaneous stimulation
Measured: 24 months post surgery or post transcutaneous stimulation
Change of delta cerebral artery velocity from baseline to immediately post-operation or post transcutaneous stimulation
Change of on-off delta cerebral artery velocity from baseline to immediately post-operation or post transcutaneous stimulation. Delta cerebral artery velocity equals cerebral artery velocity of the patient lying minus the systolic blood pressure of the patient standing up for 10 minutes.
Measured: Immediately post surgery or post transcutaneous stimulation
Change of delta cerebral artery velocity from baseline to 3 months post-operation or post transcutaneous stimulation
Change of on-off delta cerebral artery velocity from baseline to 3 months post-operation or post transcutaneous stimulation. Delta cerebral artery velocity equals cerebral artery velocity of the patient lying minus the systolic blood pressure of the patient standing up for 10 minutes.
Measured: 3 months post surgery or post transcutaneous stimulation
Change of delta cerebral artery velocity from baseline to 6 months post-operation or post transcutaneous stimulation
Change of on-off delta cerebral artery velocity from baseline to 6 months post-operation or post transcutaneous stimulation. Delta cerebral artery velocity equals cerebral artery velocity of the patient lying minus the systolic blood pressure of the patient standing up for 10 minutes.
Measured: 6 months post surgery or post transcutaneous stimulation
Change of delta cerebral artery velocity from baseline to 9 months post-operation or post transcutaneous stimulation
Change of on-off delta cerebral artery velocity from baseline to 9 months post-operation or post transcutaneous stimulation. Delta cerebral artery velocity equals cerebral artery velocity of the patient lying minus the systolic blood pressure of the patient standing up for 10 minutes.
Measured: 9 months post surgery or post transcutaneous stimulation
Change of delta cerebral artery velocity from baseline to 12 months post-operation or post transcutaneous stimulation
Change of on-off delta cerebral artery velocity from baseline to 12 months post-operation or post transcutaneous stimulation. Delta cerebral artery velocity equals cerebral artery velocity of the patient lying minus the systolic blood pressure of the patient standing up for 10 minutes.
Measured: 12 months post surgery or post transcutaneous stimulation
Change of delta cerebral artery velocity from baseline to 18 months post-operation or post transcutaneous stimulation
Change of on-off delta cerebral artery velocity from baseline to 18 months post-operation or post transcutaneous stimulation. Delta cerebral artery velocity equals cerebral artery velocity of the patient lying minus the systolic blood pressure of the patient standing up for 10 minutes.
Measured: 18 months post surgery or post transcutaneous stimulation
Change of delta cerebral artery velocity from baseline to 24 months post-operation or post transcutaneous stimulation
Change of on-off delta cerebral artery velocity from baseline to 24 months post-operation or post transcutaneous stimulation. Delta cerebral artery velocity equals cerebral artery velocity of the patient lying minus the systolic blood pressure of the patient standing up for 10 minutes.
Measured: 24 months post surgery or post transcutaneous stimulation
Change of TUG from baseline to immediately post-operation or post transcutaneous stimulation
Change of on-off timed up and go from baseline to immediately post-operation or post transcutaneous stimulation
Measured: Immediately post surgery or post transcutaneous stimulation
Change of TUG from baseline to 3 months post-operation or post transcutaneous stimulation
Change of on-off timed up and go from baseline to 3 months post-operation or post transcutaneous stimulation
Measured: 3 months post surgery or post transcutaneous stimulation
Change of TUG from baseline to 6 months post-operation or post transcutaneous stimulation
Change of on-off timed up and go from baseline to 6 months post-operation or post transcutaneous stimulation
Measured: 6 months post surgery or post transcutaneous stimulation
Change of TUG from baseline to 9 months post-operation or post transcutaneous stimulation
Change of on-off timed up and go from baseline to 9 months post-operation or post transcutaneous stimulation
Measured: 9 months post surgery or post transcutaneous stimulation
Change of TUG from baseline to 12 months post-operation or post transcutaneous stimulation
Change of on-off timed up and go from baseline to 12 months post-operation or post transcutaneous stimulation
Measured: 12 months post surgery or post transcutaneous stimulation
Change of TUG from baseline to 18 months post-operation or post transcutaneous stimulation
Change of on-off timed up and go from baseline to 18 months post-operation or post transcutaneous stimulation
Measured: 18 months post surgery or post transcutaneous stimulation
Change of TUG from baseline to 24 months post-operation or post transcutaneous stimulation
Change of on-off timed up and go from baseline to 24 months post-operation or post transcutaneous stimulation
Measured: 24 months post surgery or post transcutaneous stimulation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202630 Jun 2028

First posted7 Jan 2026
Study start1 Jan 2026 (estimated)
Primary completion30 Jun 2028 (estimated)
Study completion30 Jun 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for ParkinsonismStudies of the same condition, open and under way.
More trials run by Ruijin HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 40 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07322458
Sponsor's protocol ID: PDS_OH_tSCS
Status last verified: Sep 2025
First submitted: 21 Dec 2025
Last updated: 9 Jan 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Jun LIU, MD, PhD

021-64370045

jly0520@hotmail.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)

All Parkinsonism trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Spinal Cord Stimulation on Orthostatic Hypotension in Parkinsonism and Its Related Mechanisms
ClinicalTrials.gov ID: NCT07322458
Acronym / sponsor ID: PDS_OH_tSCS
Conditions: Parkinsonism
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 40 participants (estimated)
Lead sponsor: Ruijin HospitalUniversity, hospital or other
Study start: 1 Jan 2026 (estimated)
Primary completion: 30 Jun 2028 (estimated)
Study completion: 30 Jun 2028 (estimated)
First posted: 7 Jan 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Epidural spinal cord stimulation (eSCS) implantation	Experimental	Device: Epidural spinal cord stimulationPhase I: (1) Spinal cord segment is selected as the puncture location according to the patient's symptom and the condition of the patient's spinal cord. Percutaneous puncture is performed under X-ray guidance. One or two electrodes are placed in the patient's epidural cavity, and the electrode position is adjusted intraoperatively and by the patient's feedback of the current stimulation position until the current can cover the entire area. (2) An extension lead is connected, an external temporary stimulator is attached, and the patient decides whether to proceed to full implantation in phase II after 7-10 days of phase I testing experience. Phase II: The complete SCS system is implanted under local anesthesia or epidural anesthesia after successful testing. A subcutaneous capsular bag is usually created in the lower abdomen and the implanted electrodes are connected to the pulse generator through a connecting wire in the subcutaneous tunnel.
Transcutaneous spinal cord stimulation (tSCS) application	Experimental	Device: Transcutaneous spinal cord stimulationAfter completing the necessary assessments and informed consent procedures, subjects will undergo device installation and seated programming. The cathode of the tSCS device will be placed at the level of the lower thoracic spinal cord via a hydrogel adhesive electrode, and the anode will be placed bilaterally at the iliac crest via a hydrogel adhesive electrode. During seated programming, subjects will undergo continuous non-invasive blood pressure monitoring and a medication-free head-up tilt test (TTT). If subjects demonstrate a satisfactory clinical response during the testing phase (defined as an increase in systolic blood pressure of more than 15-20 mmHg with stimulation on compared to the off state), they will enter regular tSCS therapy during the treatment phase.

Who may qualify

Ages: 40 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

1. Aged between 40 and 80 years;
2. No dementia as measured by the cMMSE scale (formal cMMSE score should be >20 for subjects with 1 to 6 years of formal education; cMMSE score should be >24 for subjects with >6 years of formal education);
3. Able and willing to follow instruction of the researcher;
4. No other conditions that the researchers consider inappropriate for inclusion:

Key exclusion criteria (5 listed)

1. Severe depression (HAMD-17 above 17 as moderate to severe) or anxiety;
2. Pregnancy;
3. History of alcoholism;
4. No skin abnormalities;
5. Non-neurological disease-related symptoms that prevent patients from participation in the study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Epidural spinal cord stimulationEpidural spinal cord stimulation (eSCS) is a very thin electrode implanted in the dorsal epidural space of the spinal cord to improve the patient's symptoms by stimulating the spinal nerves with pulsed electrical currents, which attenuate or enhance the flow of nerve impulses from the periphery to the central system, i.e., stimulating thick fibres to achieve therapeutic results. SCS system consists of three components: an electrode implanted in the epidural space of the patient's spinal cord, a stimulator implanted subcutaneously in the abdomen or buttocks that delivers electrical impulses, and an extension cord that connects the two.	Device	Epidural spinal cord stimulation (eSCS) implantation
Transcutaneous spinal cord stimulationTranscutaneous spinal cord stimulation (tSCS) is a non-invasive treatment that improves symptoms by stimulating spinal nerves with pulsed electrical currents via electrodes placed at corresponding spinal cord segments. The tSCS system consists of an electrical pulse stimulator, wires, and conductive patches.	Device	Transcutaneous spinal cord stimulation (tSCS) application

Primary outcome

Change of blood pressure from baseline to immediately post-operation or post transcutaneous stimulation
Time frame: Immediately post surgery or post transcutaneous stimulation
Changes of on-off delta systolic and delta diastolic blood pressure from baseline to immediately post-operation or post-stimulation. Delta systolic blood pressure equals the systolic blood pressure of the patient lying minus the systolic blood pressure of the patient standing up for 10 minutes. Delta diastolic blood pressure equals the diastolic blood pressure of the patient lying minus the diastolic blood pressure of the patient standing up for 10 minutes.
Change of blood pressure from baseline to 3 months post-operation or post transcutaneous stimulation
Time frame: 3 months post surgery or post transcutaneous stimulation
Changes of on-off delta systolic and delta diastolic blood pressure from baseline to 3 months post-operation or post-stimulation. Delta systolic blood pressure equals the systolic blood pressure of the patient lying minus the systolic blood pressure of the patient standing up for 10 minutes. Delta diastolic blood pressure equals the diastolic blood pressure of the patient lying minus the diastolic blood pressure of the patient standing up for 10 minutes.
Change of blood pressure from baseline to 6 months post-operation or post transcutaneous stimulation
Time frame: 6 months post surgery or post transcutaneous stimulation
Changes of on-off delta systolic and delta diastolic blood pressure from baseline to 6 months post-operation or post-stimulation. Delta systolic blood pressure equals the systolic blood pressure of the patient lying minus the systolic blood pressure of the patient standing up for 10 minutes. Delta diastolic blood pressure equals the diastolic blood pressure of the patient lying minus the diastolic blood pressure of the patient standing up for 10 minutes.
Change of blood pressure from baseline to 9 months post-operation or post transcutaneous stimulation
Time frame: 9 months post surgery or post transcutaneous stimulation
Changes of on-off delta systolic and delta diastolic blood pressure from baseline to immediately post-operation or post-stimulation. Delta systolic blood pressure equals the systolic blood pressure of the patient lying minus the systolic blood pressure of the patient standing up for 10 minutes. Delta diastolic blood pressure equals the diastolic blood pressure of the patient lying minus the diastolic blood pressure of the patient standing up for 10 minutes.
Change of blood pressure from baseline to 12 months post-operation or post transcutaneous stimulation
Time frame: 12 months post surgery or post transcutaneous stimulation
Changes of on-off delta systolic and delta diastolic blood pressure from baseline to 12 months post-operation or post-stimulation. Delta systolic blood pressure equals the systolic blood pressure of the patient lying minus the systolic blood pressure of the patient standing up for 10 minutes. Delta diastolic blood pressure equals the diastolic blood pressure of the patient lying minus the diastolic blood pressure of the patient standing up for 10 minutes.
Change of blood pressure from baseline to 18 months post-operation or post transcutaneous stimulation
Time frame: 18 months post surgery or post transcutaneous stimulation
Changes of on-off delta systolic and delta diastolic blood pressure from baseline to 18 months post-operation or post-stimulation. Delta systolic blood pressure equals the systolic blood pressure of the patient lying minus the systolic blood pressure of the patient standing up for 10 minutes. Delta diastolic blood pressure equals the diastolic blood pressure of the patient lying minus the diastolic blood pressure of the patient standing up for 10 minutes.
Change of blood pressure from baseline to 24 months post-operation or post transcutaneous stimulation
Time frame: 24 months post surgery or post transcutaneous stimulation
Changes of on-off delta systolic and delta diastolic blood pressure from baseline to 24 months post-operation or post-stimulation. Delta systolic blood pressure equals the systolic blood pressure of the patient lying minus the systolic blood pressure of the patient standing up for 10 minutes. Delta diastolic blood pressure equals the diastolic blood pressure of the patient lying minus the diastolic blood pressure of the patient standing up for 10 minutes.

140 secondary outcomes

Change of oxygen desaturation index from baseline to immediately post-operation or post transcutaneous stimulation
Time frame: Immediately post surgery or post transcutaneous stimulation
Change of oxygen desaturation index from baseline to 3 months post-operation or post transcutaneous stimulation
Time frame: 3 months post surgery or post transcutaneous stimulation
Change of oxygen desaturation index from baseline to 6 months post-operation or post transcutaneous stimulation
Time frame: 6 months post surgery or post transcutaneous stimulation
Change of oxygen desaturation index from baseline to 9 months post-operation or post transcutaneous stimulation
Time frame: 9 months post surgery or post transcutaneous stimulation
Change of oxygen desaturation index from baseline to 12 months post-operation or post transcutaneous stimulation
Time frame: 12 months post surgery or post transcutaneous stimulation
Change of oxygen desaturation index from baseline to 18 months post-operation or post transcutaneous stimulation
Time frame: 18 months post surgery or post transcutaneous stimulation
Change of oxygen desaturation index from baseline to 24 months post-operation or post transcutaneous stimulation
Time frame: 24 months post surgery or post transcutaneous stimulation
Change of apnea hypopnea index from baseline to immediately post-operation or post transcutaneous stimulation
Time frame: Immediately post surgery or post transcutaneous stimulation
Change of apnea hypopnea index from baseline to 3 months post-operation or post transcutaneous stimulation
Time frame: 3 months post surgery or post transcutaneous stimulation
Change of apnea hypopnea index from baseline to 6 months post-operation or post transcutaneous stimulation
Time frame: 6 months post surgery or post transcutaneous stimulation
Change of apnea hypopnea index from baseline to 9 months post-operation or post transcutaneous stimulation
Time frame: 9 months post surgery or post transcutaneous stimulation
Change of apnea hypopnea index from baseline to 12 months post-operation or post transcutaneous stimulation
Time frame: 12 months post surgery or post transcutaneous stimulation
Change of apnea hypopnea index from baseline to 18 months post-operation or post transcutaneous stimulation
Time frame: 18 months post surgery or post transcutaneous stimulation
Change of apnea hypopnea index from baseline to 24 months post-operation or post transcutaneous stimulation
Time frame: 24 months post surgery or post transcutaneous stimulation
Change of on-off 24-hour blood pressure monitoring from baseline to immediately post-operation or post transcutaneous stimulation
Time frame: Immediately post surgery or post transcutaneous stimulation
Change of on-off 24-hour blood pressure monitoring from baseline to 3 months post-operation or post transcutaneous stimulation
Time frame: 3 months post surgery or post transcutaneous stimulation
Change of on-off 24-hour blood pressure monitoring from baseline to 6 months post-operation or post transcutaneous stimulation
Time frame: 6 months post surgery or post transcutaneous stimulation
Change of on-off 24-hour blood pressure monitoring from baseline to 9 months post-operation or post transcutaneous stimulation
Time frame: 9 months post surgery or post transcutaneous stimulation
Change of on-off 24-hour blood pressure monitoring from baseline to 12 months post-operation or post transcutaneous stimulation
Time frame: 12 months post surgery or post transcutaneous stimulation
Change of on-off 24-hour blood pressure monitoring from baseline to 18 months post-operation or post transcutaneous stimulation
Time frame: 18 months post surgery or post transcutaneous stimulation
Change of on-off 24-hour blood pressure monitoring from baseline to 24 months post-operation or post transcutaneous stimulation
Time frame: 24 months post surgery or post transcutaneous stimulation
Change of on-off time patient spend in supine status, seated status, standing/walking status from baseline to immediately post-operation or post transcutaneous stimulation
Time frame: Immediately post surgery or post transcutaneous stimulation
Change of on-off time patient spend in supine status, seated status, standing/walking status from baseline to 3 months post-operation or post transcutaneous stimulation
Time frame: 3 months post surgery or post transcutaneous stimulation
Change of on-off time patient spend in supine status, seated status, standing/walking status from baseline to 6 months post-operation or post transcutaneous stimulation
Time frame: 6 months post surgery or post transcutaneous stimulation
Change of on-off time patient spend in supine status, seated status, standing/walking status from baseline to 9 months post-operation or post transcutaneous stimulation
Time frame: 9 months post surgery or post transcutaneous stimulation
Change of on-off time patient spend in supine status, seated status, standing/walking status from baseline to 12 months post-operation or post transcutaneous stimulation
Time frame: 12 months post surgery or post transcutaneous stimulation
Change of on-off time patient spend in supine status, seated status, standing/walking status from baseline to 18 months post-operation or post transcutaneous stimulation
Time frame: 18 months post surgery or post transcutaneous stimulation
Change of on-off time patient spend in supine status, seated status, standing/walking status from baseline to 24 months post-operation or post transcutaneous stimulation
Time frame: 24 months post surgery or post transcutaneous stimulation
Change of serum catecholamine neurotransmitter levels from baseline to immediately post-operation or post transcutaneous stimulation
Time frame: Immediately post surgery or post transcutaneous stimulation
Change of serum catecholamine neurotransmitter levels from baseline to 3 months post-operation or post transcutaneous stimulation
Time frame: 3 months post surgery or post transcutaneous stimulation
Change of serum catecholamine neurotransmitter levels from baseline to 6 months post-operation or post transcutaneous stimulation
Time frame: 6 months post surgery or post transcutaneous stimulation
Change of serum catecholamine neurotransmitter levels from baseline to 9 months post-operation or post transcutaneous stimulation
Time frame: 9 months post surgery or post transcutaneous stimulation
Change of serum catecholamine neurotransmitter levels from baseline to 12 months post-operation or post transcutaneous stimulation
Time frame: 12 months post surgery or post transcutaneous stimulation
Change of serum catecholamine neurotransmitter levels from baseline to 18 months post-operation or post transcutaneous stimulation
Time frame: 18 months post surgery or post transcutaneous stimulation
Change of serum catecholamine neurotransmitter levels from baseline to 24 months post-operation or post transcutaneous stimulation
Time frame: 24 months post surgery or post transcutaneous stimulation
Change of on-off delta heart rate variability from baseline to immediately post-operation or post transcutaneous stimulation
Time frame: Immediately post surgery or post transcutaneous stimulation
Change of on-off delta heart rate variability from baseline to 3 months post-operation or post transcutaneous stimulation
Time frame: 3 months post surgery or post transcutaneous stimulation
Change of on-off delta heart rate variability from baseline to 6 months post-operation or post transcutaneous stimulation
Time frame: 6 months post surgery or post transcutaneous stimulation
Change of on-off delta heart rate variability from baseline to 9 months post-operation or post transcutaneous stimulation
Time frame: 9 months post surgery or post transcutaneous stimulation
Change of on-off delta heart rate variability from baseline to 12 months post-operation or post transcutaneous stimulation
Time frame: 12 months post surgery or post transcutaneous stimulation

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Jun LIU, MD, PhD contact

021-64370045

jly0520@hotmail.com

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Epidural spinal cord stimulation and Transcutaneous spinal cord stimulation in people with Parkinsonism, run by Ruijin Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jun LIU, MD, PhD (021-64370045, jly0520@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of blood pressure from baseline to immediately post-operation or post transcutaneous stimulation (time frame: Immediately post surgery or post transcutaneous stimulation). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07322458.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.