Neurogenic Orthostatic HypotensionNCT07879391
Spinal Cord Stimulation for Neurogenic Orthostatic Hypotension
A study testing Lower thoracic epidural spinal cord stimulation in people with Neurogenic Orthostatic Hypotension, run by Aerospace Center Hospital.
Trial summary
Neurogenic orthostatic hypotension is a disabling manifestation of synucleinopathies including Parkinson's disease, multiple system atrophy, dementia with Lewy bodies, and pure autonomic failure. It commonly coexists with supine hypertension and requires individualized management. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neurogenic Orthostatic Hypotension
- What is being tested?
- Lower thoracic epidural spinal cord stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 31 Dec 2029
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 80 years.
- Diagnosis of Parkinson's disease, multiple system atrophy, dementia with Lewy bodies, or pure autonomic failure by a neurologist using applicable accepted diagnostic criteria at screening.
- Neurogenic orthostatic hypotension documented by a standardized active standing test or tilt-table test: after at least 5 minutes of supine rest, a reduction in systolic blood pressure of at least 20 mmHg or diastolic blood pressure of at least 10 mmHg within 3 minutes of standing. A systolic reduction of at least 30 mmHg may support eligibility in participants with supine hypertension.
- Orthostatic symptoms or fall risk that remain clinically meaningful despite standardized nonpharmacologic management and stable usual medical management.
- Ability to understand study procedures and provide written informed consent. Participants with mild cognitive impairment require sufficient ability to complete safety assessments and, where required by the ethics committee, involvement of a legally authorized representative.
Who cannot join
- Orthostatic hypotension primarily attributable to a non-neurogenic or reversible cause, including uncorrected hypovolemia, recent major blood loss, or an active medication-adjustment period.
- Uncontrolled heart failure, active myocardial ischemia, clinically significant arrhythmia, or other cardiovascular disease making surgery, sedation, or orthostatic testing unsafe.
- Persistent severe supine hypertension, defined as repeated systolic blood pressure of at least 180 mmHg or diastolic blood pressure of at least 110 mmHg after clinical optimization, that makes stimulation titration unsuitable.
- Active infection, coagulopathy, inability to interrupt anticoagulant or antiplatelet therapy when required for epidural procedures, or another contraindication to epidural access or implantation.
- Severe thoracolumbar spinal deformity, prior fusion in the intended lead-placement region, or imaging evidence that makes epidural placement unsuitable.
- An implanted electronic medical device that is contraindicated or cannot be safely managed with the study stimulation system after specialist assessment.
- Severe cognitive, psychiatric, or communication impairment that prevents safe participation, symptom reporting, or follow-up.
- Pregnancy, breastfeeding, or planned pregnancy during study follow-up.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective, Single-Center, Open-Label, Single-Arm Feasibility Study of Lower Thoracic Epidural Spinal Cord Stimulation for Neurogenic Orthostatic Hypotension
Neurogenic orthostatic hypotension is a disabling manifestation of synucleinopathies including Parkinson's disease, multiple system atrophy, dementia with Lewy bodies, and pure autonomic failure. It commonly coexists with supine hypertension and requires individualized management. An implanted thoracic epidural stimulation system improved blood-pressure regulation, standing, and walking in a patient with multiple system atrophy, providing a rationale for further feasibility evaluation. This study evaluates the feasibility, safety, and preliminary hemodynamic response of lower thoracic epidural spinal cord stimulation in participants with symptomatic neurogenic orthostatic hypotension. All participants undergo surgical percutaneous placement of a lower thoracic epidural spinal cord stimulation lead, followed by an externalized trial stimulation period generally lasting no more than 2 weeks. During this period, the acute hemodynamic effect of stimulation is evaluated with a within-participant randomized stimulation ON/OFF comparison during a standardized orthostatic challenge. Participants who meet predefined response and safety criteria receive permanent implantation of the compatible spinal cord stimulation system. After permanent implantation, follow-up occurs at 1, 3, 6, and 12 months to evaluate symptom improvement and safety.
Read the detailed description
The study evaluates a commercially available 16-contact spinal cord stimulation electrode manufactured by PINS Medical, used with its compatible implanted stimulation system. The intended epidural target spans the T10 to T12 vertebral levels. This target is a study hypothesis informed by the rationale of spinal autonomic neuromodulation; it is not an established optimal target for neurogenic orthostatic hypotension. The device model, China registration certificate number, implantable pulse generator model, magnetic resonance imaging conditions, and permitted programming range will be documented before enrollment.
All participants undergo surgical percutaneous placement of a lower thoracic epidural spinal cord stimulation lead, followed by an externalized trial stimulation period generally lasting no more than 2 weeks. During this period, the acute hemodynamic effect of stimulation is evaluated with a within-participant randomized stimulation ON/OFF comparison during a standardized orthostatic challenge. Participants who meet predefined response and safety criteria receive permanent implantation of the compatible stimulation system. After permanent implantation, follow-up occurs at 1 month, 3 months, 6 months, and 1 year to evaluate symptom improvement and safety.
- Conditions
- Neurogenic Orthostatic Hypotension
- Being tested
- Lower thoracic epidural spinal cord stimulation
- Keywords
- Neurogenic Orthostatic Hypotension, Spinal Cord Stimulation, Single-Arm Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lower thoracic epidural spinal cord stimulationDevice
A 16-contact epidural spinal cord stimulation lead is placed with active contacts covering the intended T10 to T12 region. The lead is externalized for a trial stimulation period generally lasting no more than 2 weeks. During this period, the acute hemodynamic effect of stimulation is assessed using a within-participant randomized stimulation ON/OFF comparison during a standardized orthostatic challenge. Participants meeting predefined response and safety criteria proceed to permanent implantation of the compatible spinal cord stimulation system. Initial programming uses individualized low-to-high titration within the device instructions for use: frequency 5 to 50 Hz and pulse width 200 to 500 μs. Amplitude increases from a subperception or lowest perceptible level until hemodynamic benefit, intolerable symptoms, or the device-specific permitted limit is reached.
| Study group | Role | What they receive |
|---|---|---|
| Lower Thoracic Epidural Spinal Cord Stimulation | Experimental | All participants undergo surgical percutaneous placement of a lower thoracic epidural spinal cord stimulation lead, followed by an externalized trial stimulation period generally lasting no more than 2 weeks. During this period, the acute hemodynamic effect of stimulation is evaluated with a within-participant randomized stimulation ON/OFF comparison during a standardized orthostatic challenge. Participants who meet predefined response and safety criteria receive permanent implantation of the compatible spinal cord stimulation system. After permanent implantation, follow-up occurs at 1, 3, 6, and 12 months to evaluate symptom improvement and safety. Receives: Device: Lower thoracic epidural spinal cord stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in lowest systolic blood pressure during standardized orthostatic challenge with stimulation ON versus OFF
During the externalized trial stimulation period, each participant completes standardized orthostatic challenges under randomized stimulation ON and OFF conditions. After at least 5 minutes of supine rest, blood pressure is measured continuously from the start of standing until 10 minutes of standing or until a prespecified stopping criterion is met. The lowest systolic blood pressure in each condition is identified. The outcome is the difference in lowest systolic blood pressure during stimulation ON versus OFF, calculated as ON minus OFF, in mmHg. A positive value indicates a higher lowest systolic blood pressure with stimulation ON. The ON and OFF order is randomized within each participant.
Measured: During the externalized trial stimulation period, generally no more than 2 weeks after lead placement
Secondary outcomes (7)
Feasibility of the trial-to-implant pathway
Proportion of enrolled participants who complete the externalized trial stimulation period, meet predefined trial success criteria, receive permanent implantation of the spinal cord stimulation system, and complete scheduled follow-up assessments. Trial success is defined as at least one standardized orthostatic assessment during trial stimulation showing either an increase of at least 10 mmHg in the lowest systolic blood pressure with stimulation ON versus OFF, or an increase of at least 30% in orthostatic tolerance time, together with participant-reported overall symptom improvement and no device- or procedure-related serious adverse event.
Measured: From enrollment through 12 months after permanent implantation
Orthostatic blood-pressure response
Change in systolic and diastolic blood pressure from supine baseline during standardized orthostatic challenge, time to lowest blood pressure, and occurrence of systolic blood pressure below 90 mmHg within 10 minutes of standing. Blood pressure is measured after at least 5 minutes of supine rest and continuously from standing onset until 10 minutes of standing or until a prespecified stopping criterion is met. A greater increase in blood pressure from supine baseline indicates better orthostatic blood-pressure response.
Measured: Baseline; externalized trial stimulation period; 1, 3, 6, and 12 months after permanent implantation
Orthostatic tolerance time
Duration of tolerated standing during the standardized orthostatic challenge, up to 10 minutes. The reason for early termination, including presyncope, syncope, intolerable symptoms, or safety concern, is recorded. A longer tolerated standing time indicates better orthostatic tolerance. Participants who complete 10 minutes of standing without early termination are assigned the maximum value of 10 minutes.
Measured: Baseline; externalized trial stimulation period; 1, 3, 6, and 12 months after permanent implantation
Orthostatic symptom burden
Change in score on a licensed or linguistically validated Chinese orthostatic hypotension symptom measure. The scale range and direction of possible scores will be provided once the instrument is confirmed. A decrease in score indicates improvement in orthostatic symptom burden if the selected instrument uses a higher score to indicate worse symptoms.
Measured: Baseline; externalized trial stimulation period; 1, 3, 6, and 12 months after permanent implantation
Patient Global Impression of Change
Participant-rated global change in orthostatic symptoms. Participants rate their overall change in orthostatic symptoms compared with baseline using a validated Patient Global Impression of Change scale. The scale typically ranges from 1 to 7, with 1 indicating very much improved and 7 indicating very much worse, or according to the validated version used.
Measured: Externalized trial stimulation period; 1, 3, 6, and 12 months after permanent implantation
Supine hypertension and ambulatory blood pressure
Supine blood pressure after 5 minutes of rest and prespecified metrics from 24-hour ambulatory blood-pressure monitoring, including nighttime blood pressure where available.Metrics may include mean 24-hour, daytime, and nighttime systolic and diastolic blood pressure, as well as the proportion of participants with supine systolic blood pressure at least 180 mmHg or diastolic blood pressure at least 110 mmHg. A lower supine blood pressure indicates less severe supine hypertension.
Measured: Baseline; externalized trial stimulation period; 1, 3, 6, and 12 months after permanent implantation
Device-, procedure-, and stimulation-related adverse events
Number and proportion of participants with adverse events and serious adverse events, classified by severity, relationship to device or procedure, action taken, and outcome. Events are assessed from consent through 12 months after permanent implantation and are coded according to the applicable regulatory and institutional standards.
Measured: From consent through 12 months after permanent implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start1 Dec 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurogenic Orthostatic HypotensionStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aerospace Center Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07879391
- Sponsor's protocol ID
- Neurosurgery-2603
- Status last verified
- Oct 2026
- First submitted
- 10 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Center, Open-Label, Single-Arm Feasibility Study of Lower Thoracic Epidural Spinal Cord Stimulation for Neurogenic Orthostatic Hypotension
- ClinicalTrials.gov ID
- NCT07879391
- Acronym / sponsor ID
- Neurosurgery-2603
- Conditions
- Neurogenic Orthostatic Hypotension
- Keywords
- Neurogenic Orthostatic Hypotension, Spinal Cord Stimulation, Single-Arm Study
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Aerospace Center HospitalUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 16 Oct 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.
Neurogenic orthostatic hypotension is a disabling manifestation of synucleinopathies including Parkinson's disease, multiple system atrophy, dementia with Lewy bodies, and pure autonomic failure. It commonly coexists with supine hypertension and requires individualized management. An implanted thoracic epidural stimulation system improved blood-pressure regulation, standing, and walking in a patient with multiple system atrophy, providing a rationale for further feasibility evaluation. This study evaluates the feasibility, safety, and preliminary hemodynamic response of lower thoracic epidural spinal cord stimulation in participants with symptomatic neurogenic orthostatic hypotension. All participants undergo surgical percutaneous placement of a lower thoracic epidural spinal cord stimulation lead, followed by an externalized trial stimulation period generally lasting no more than 2 weeks. During this period, the acute hemodynamic effect of stimulation is evaluated with a within-participant randomized stimulation ON/OFF comparison during a standardized orthostatic challenge. Participants who meet predefined response and safety criteria receive permanent implantation of the compatible spinal cord stimulation system. After permanent implantation, follow-up occurs at 1, 3, 6, and 12 months to evaluate symptom improvement and safety.
Detailed description
The study evaluates a commercially available 16-contact spinal cord stimulation electrode manufactured by PINS Medical, used with its compatible implanted stimulation system. The intended epidural target spans the T10 to T12 vertebral levels. This target is a study hypothesis informed by the rationale of spinal autonomic neuromodulation; it is not an established optimal target for neurogenic orthostatic hypotension. The device model, China registration certificate number, implantable pulse generator model, magnetic resonance imaging conditions, and permitted programming range will be documented before enrollment.
All participants undergo surgical percutaneous placement of a lower thoracic epidural spinal cord stimulation lead, followed by an externalized trial stimulation period generally lasting no more than 2 weeks. During this period, the acute hemodynamic effect of stimulation is evaluated with a within-participant randomized stimulation ON/OFF comparison during a standardized orthostatic challenge. Participants who meet predefined response and safety criteria receive permanent implantation of the compatible stimulation system. After permanent implantation, follow-up occurs at 1 month, 3 months, 6 months, and 1 year to evaluate symptom improvement and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lower Thoracic Epidural Spinal Cord Stimulation | Experimental | Device: Lower thoracic epidural spinal cord stimulationAll participants undergo surgical percutaneous placement of a lower thoracic epidural spinal cord stimulation lead, followed by an externalized trial stimulation period generally lasting no more than 2 weeks. During this period, the acute hemodynamic effect of stimulation is evaluated with a within-participant randomized stimulation ON/OFF comparison during a standardized orthostatic challenge. Participants who meet predefined response and safety criteria receive permanent implantation of the compatible spinal cord stimulation system. After permanent implantation, follow-up occurs at 1, 3, 6, and 12 months to evaluate symptom improvement and safety. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 to 80 years.
- Diagnosis of Parkinson's disease, multiple system atrophy, dementia with Lewy bodies, or pure autonomic failure by a neurologist using applicable accepted diagnostic criteria at screening.
- Neurogenic orthostatic hypotension documented by a standardized active standing test or tilt-table test: after at least 5 minutes of supine rest, a reduction in systolic blood pressure of at least 20 mmHg or diastolic blood pressure of at least 10 mmHg within 3 minutes of standing. A systolic reduction of at least 30 mmHg may support eligibility in participants with supine hypertension.
- Orthostatic symptoms or fall risk that remain clinically meaningful despite standardized nonpharmacologic management and stable usual medical management.
- Ability to understand study procedures and provide written informed consent. Participants with mild cognitive impairment require sufficient ability to complete safety assessments and, where required by the ethics committee, involvement of a legally authorized representative.
Key exclusion criteria (8 listed)
- Orthostatic hypotension primarily attributable to a non-neurogenic or reversible cause, including uncorrected hypovolemia, recent major blood loss, or an active medication-adjustment period.
- Uncontrolled heart failure, active myocardial ischemia, clinically significant arrhythmia, or other cardiovascular disease making surgery, sedation, or orthostatic testing unsafe.
- Persistent severe supine hypertension, defined as repeated systolic blood pressure of at least 180 mmHg or diastolic blood pressure of at least 110 mmHg after clinical optimization, that makes stimulation titration unsuitable.
- Active infection, coagulopathy, inability to interrupt anticoagulant or antiplatelet therapy when required for epidural procedures, or another contraindication to epidural access or implantation.
- Severe thoracolumbar spinal deformity, prior fusion in the intended lead-placement region, or imaging evidence that makes epidural placement unsuitable.
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 |
|---|---|---|
| Lower thoracic epidural spinal cord stimulationA 16-contact epidural spinal cord stimulation lead is placed with active contacts covering the intended T10 to T12 region. The lead is externalized for a trial stimulation period generally lasting no more than 2 weeks. During this period, the acute hemodynamic effect of stimulation is assessed using a within-participant randomized stimulation ON/OFF comparison during a standardized orthostatic challenge. Participants meeting predefined response and safety criteria proceed to permanent implantation of the compatible spinal cord stimulation system. Initial programming uses individualized low-to-high titration within the device instructions for use: frequency 5 to 50 Hz and pulse width 200 to 500 μs. Amplitude increases from a subperception or lowest perceptible level until hemodynamic benefit, intolerable symptoms, or the device-specific permitted limit is reached. | Device | Lower Thoracic Epidural Spinal Cord Stimulation |
Primary outcome
Difference in lowest systolic blood pressure during standardized orthostatic challenge with stimulation ON versus OFF
Time frame: During the externalized trial stimulation period, generally no more than 2 weeks after lead placement
During the externalized trial stimulation period, each participant completes standardized orthostatic challenges under randomized stimulation ON and OFF conditions. After at least 5 minutes of supine rest, blood pressure is measured continuously from the start of standing until 10 minutes of standing or until a prespecified stopping criterion is met. The lowest systolic blood pressure in each condition is identified. The outcome is the difference in lowest systolic blood pressure during stimulation ON versus OFF, calculated as ON minus OFF, in mmHg. A positive value indicates a higher lowest systolic blood pressure with stimulation ON. The ON and OFF order is randomized within each participant.
7 secondary outcomes
Feasibility of the trial-to-implant pathway
Time frame: From enrollment through 12 months after permanent implantation
Orthostatic blood-pressure response
Time frame: Baseline; externalized trial stimulation period; 1, 3, 6, and 12 months after permanent implantation
Orthostatic tolerance time
Time frame: Baseline; externalized trial stimulation period; 1, 3, 6, and 12 months after permanent implantation
Orthostatic symptom burden
Time frame: Baseline; externalized trial stimulation period; 1, 3, 6, and 12 months after permanent implantation
Patient Global Impression of Change
Time frame: Externalized trial stimulation period; 1, 3, 6, and 12 months after permanent implantation
Supine hypertension and ambulatory blood pressure
Time frame: Baseline; externalized trial stimulation period; 1, 3, 6, and 12 months after permanent implantation
Device-, procedure-, and stimulation-related adverse events
Time frame: From consent through 12 months after permanent implantation
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 16 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Lower thoracic epidural spinal cord stimulation in people with Neurogenic Orthostatic Hypotension, run by Aerospace Center Hospital.
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 5 inclusion and 8 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 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Mingming Zhao, Doctor of Medicine(M.D.) (86-010-59971952, mingming157@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in lowest systolic blood pressure during standardized orthostatic challenge with stimulation ON versus OFF (time frame: During the externalized trial stimulation period, generally no more than 2 weeks after lead placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2026.