Parkinson DiseaseTIS-STN-PD1NCT07361250
Subthalamic Nucleus (STN)-Targeted Transcranial Temporal Interference Stimulation (TIS) for Parkinson's Disease: Efficacy and Safety From a Single-Center, Prospective, Double-Blind Randomized Controlled Trial
A study testing NervioX-1000 in people with Parkinson Disease, run by Tang Zhouping at 1 site in China.
Trial summary
This is a single-center, prospective, double-blind, randomized controlled trial to evaluate the efficacy and safety of transcranial temporal interference stimulation targeting the subthalamic nucleus in patients with Parkinson's disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- NervioX-1000
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2026to 20 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older, no gender restriction;
- Diagnosis of primary Parkinson's disease according to MDS criteria: specifically, the patient must (a) exhibit parkinsonism (bradykinesia + resting tremor/rigidity); (b) not meet any of the MDS absolute exclusion criteria; and (c) meet at least two MDS supportive criteria.
- Disease duration ≥1 year, stable condition;
- Hoehn-Yahr stage between 1.5 and 3, with a stable dose of levodopa or other dopaminergic medications for at least 4 weeks, responsive to levodopa-like medications, and no changes to the treatment regimen during the trial;
- Good compliance, with the patient and family willing to participate in the clinical trial, voluntarily sign the informed consent form, attend regular treatments and follow-ups, and accurately complete evaluation tasks.
Who cannot join
- Severe cognitive impairment, resulting in poor compliance due to dementia, and/or inability to sign the informed consent form;
- History of severe psychiatric disorders, patients with a Hamilton Depression Scale (HAMD) score >24;
- History of taking antipsychotic drugs, antidepressants, or other medications that may affect dopamine levels;
- History of seizures within the last year or a family history of epilepsy;
- Unable to complete MRI scanning (e.g., due to claustrophobia, or having metal implants in the body);
- Patients with severe heart, liver, or kidney diseases, severe hypertension, and severe orthostatic hypotension that affect their health condition;
Show all 13Show fewer
- Patients with severe diabetes or severe cardio-cerebrovascular diseases that affect their health condition;
- Diagnosed with malignant tumors;
- Contraindications for non-invasive electrical stimulation, such as intracranial active implants (regardless of whether they are turned on) or passive implants that may affect electrical stimulation treatment, those who have undergone stereotactic deep brain stimulation or neurotomy, or have had any surgical procedures within the last six months that the investigator believes may affect this trial;
- History of traumatic brain injury;
- Pregnant women or women planning to become pregnant;
- Subjects currently participating in other clinical trials or have participated in other clinical research within the last three months without reaching primary endpoints;
- Patients deemed unsuitable to participate in this clinical study by the investigators.
Trial locations and contacts
1 site in 1 country.
China1 site
Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 450001
About this study
Official title: Evaluation of the Efficacy and Safety of Transcranial Temporal Interference Stimulation (TIS) Targeting the Subthalamic Nucleus (STN) in Parkinson's Disease: A Single-Center, Prospective, Double-Blind, Randomized Controlled Clinical Trial
This is a single-center, prospective, double-blind, randomized controlled trial to evaluate the efficacy and safety of transcranial temporal interference stimulation targeting the subthalamic nucleus in patients with Parkinson's disease. It plans to enroll 20 eligible participants who will be randomly assigned in a 1:1 ratio to either the active TIS stimulation group or the sham stimulation group.
Read the detailed description
Parkinson's disease is a progressive neurodegenerative disorder characterized by motor dysfunction.
Temporal Interference Stimulation (TIS) is a non-invasive deep brain stimulation technique. Its core principle involves placing two pairs of transcranial stimulation electrodes on the scalp surface, each delivering high-frequency currents with slight differences. Since the human cerebral cortex does not respond to high-frequency currents, when these two currents intersect in the deep brain (i.e., the target area), they generate a low-frequency interference wave-similar to tACS-with a frequency equal to the difference between the two currents. This enables selective modulation of deep brain regions while minimizing activation of the superficial cortex. Additionally, a breakthrough aspect of TIS is its ability to flexibly adjust the stimulation target location by modifying electrode positions and current ratios. This makes it highly suitable for future clinical applications in regulating deep brain nuclei and developing personalized diagnosis and treatment plans for Parkinson's disease (PD) patients. The technology offers a non-invasive method to alter neuronal activity in deep brain nuclei and has shown promise in improving PD motor symptoms in prior proof-of-concept studies, thereby providing a potential treatment for PD motor symptoms.
In animal models, TIS has been demonstrated to have the potential to modulate the activity of brain regions closely associated with PD motor symptoms, such as the subthalamic nucleus and globus pallidus. Preliminary clinical studies have shown that TIS stimulation of the unilateral STN in PD patients resulted in alleviation of motor symptoms such as tremor and bradykinesia before and after treatment . A recent exploratory study on TIS stimulation of the right GPi also confirmed that TIS is feasible and safe for alleviating mild PD motor symptoms, particularly bradykinesia and tremor. Compared to the right side, motor symptoms (especially bradykinesia) on the left side showed more significant improvement. PD patients with more severe bradykinesia and tremor before stimulation experienced greater improvement after TIS. Current research findings suggest that TIS has the potential to improve PD motor symptoms. However, in these two studies, some patients did not respond to TIS stimulation. Although preliminary data support the therapeutic potential of TIS for PD motor symptoms, there is still a lack of large-sample, randomized controlled, and systematic studies targeting different brain regions and parameter systems. Therefore, there is an urgent need to conduct standardized clinical trials to evaluate the optimal stimulation parameters, target selection, efficacy persistence, and safety of TIS, providing evidence-based support for its further promotion and application.
This study employs a single-center, prospective, randomized, double-blind, sham-controlled design to evaluate the efficacy and safety of TIS targeting the subthalamic nucleus in Parkinson's disease patients. The study protocol involves structural MRI scanning for all participants to establish individualized computational models, with neuronavigation techniques determining optimal electrode placement. Participants are randomized to either the active stimulation group (using 2000/2130 Hz dual-frequency configuration) or the sham control group (using 2000/2000 Hz configuration). All treatment sessions are conducted during patients' "ON" medication state, administered twice daily for 30 minutes over five consecutive days. Assessment is performed through blinded evaluation by raters unaware of group allocation using standardized scales at predetermined time points. The entire process follows structured data collection and safety monitoring protocols. This study aims to systematically evaluate the therapeutic effects and safety profile of TIS for motor symptoms in Parkinson's disease, providing an evidence base for the clinical application of this novel neuromodulation approach.
- Conditions
- Parkinson Disease
- Being tested
- NervioX-1000
- Keywords
- Parkinson Disease, Temporal Interference Stimulation, Subthalamic Nucleus (STN)
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NervioX-1000Device
All participants will receive individualized T1-weighted MRI scans for computational modeling to determine optimized electrode placement and stimulation parameters for transcranial temporal interference stimulation targeting the subthalamic nucleus. The stimulation protocol is designed to generate a focal 130 Hz interference field in the target region while minimizing cortical activation. Parameters including electrode positions and current intensity are customized based on each participant's unique neuroanatomy to ensure precise and tailored neuromodulation.
| Study group | Role | What they receive |
|---|---|---|
| Active TIS stimulation | Experimental | Participants in this group will receive transcranial temporal interference stimulation targeting the subthalamic nucleus using a frequency pair of 2000 Hz and 2130 Hz. Stimulation will be delivered twice daily at the same time for 30 minutes per session over five consecutive days（only once on the 5th day）. Stimulation intensity will be individually titrated starting from a low level and gradually increased to the maximum tolerable level. All treatments will be administered during the participant's medication "on" state. Receives: Device: NervioX-1000 |
| Sham stimulation | Sham comparator | Participants in this group will receive sham stimulation using a frequency pair of 2000 Hz and 2000 Hz. Stimulation will be administered twice daily for 30 minutes per session over five consecutive days（only once on the 5th day） during the participant's medication "on" state, with current intensity individually titrated in the same manner as the active group. The sham protocol includes cutaneous sensation simulation during a 30-second ramp-up and ramp-down phase to maintain participant blinding, but does not generate an effective interference field in the deep brain target. Receives: Device: NervioX-1000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Score on Part III (Motor Examination) of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
The motor function of patients was assessed using Part III of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS-III), which has a total score range of 0 to 132. In this scale, a higher score indicates greater severity of motor symptoms and therefore a worse outcome, with 0 representing no impairment and 132 representing the most severe impairment. Changes in the score reflect the degree of improvement in motor function.
Measured: Baseline (before treatment), immediately after the 1st（day1）, 5th（day3）, and 9th（day5） stimulation sessions (each session lasts for 30 min), and at the two-week and four-week follow-ups after the completion of treatment.
Secondary outcomes (9)
MDS-UPDRS Scale Part I Non-Motor Function Score Changes
The MDS-UPDRS Scale Part I Non-Motor Function score was used to assess the patient's Cognitive impairment, hallucinations and psychiatric symptoms, depression, apathy, impulse control disorders/dopamine dysregulation syndrome, sleep disorders, pain and other sensory symptoms, and urinary symptoms, with changes in the score reflecting the degree of improvement in those functions. The score for Part I ranges from 0 to 52 points. A higher score indicates greater impairment or more severe non-motor symptoms.
Measured: Baseline (before treatment), immediately after the 9th（day5） stimulation sessions (each session lasts for 30 min), and at the two-week and four-week follow-ups after the completion of treatment.
MDS-UPDRS Scale Part II: Activities of Daily Living Score Changes
The MDS-UPDRS Scale Part II score was used to assess the patient's Activities of Daily Living, with changes in the score reflecting the degree of improvement in daily functions. The score for Part II ranges from 0 to 52 points. A higher score indicates greater impairment in daily activities.
Measured: Baseline (before treatment), immediately after the 9th（day5） stimulation sessions (each session lasts for 30 min), and at the two-week and four-week follow-ups after the completion of treatment.
MDS-UPDRS Scale Part IV: Motor Fluctuations, Dyskinesias, and Dystonia Score Changes
The MDS-UPDRS Scale Part IV score was used to assess the patient's Motor Fluctuations, Dyskinesias, and Dystonia. The score for Part IV ranges from 0 to 24 points. A higher score indicates more severe motor complications caused by long-term levodopa therapy.
Measured: Baseline (before treatment), immediately after the 9th（day5） stimulation sessions (each session lasts for 30 min), and at the two-week and four-week follow-ups after the completion of treatment.
Change in Score on the 39-item Parkinson's Disease Questionnaire (PDQ-39)
The 39-item Parkinson's Disease Questionnaire (PDQ-39) is used to assess the disease-specific health-related quality of life in patients with Parkinson's disease. The summary index score ranges from 0 to 100 points. A higher score indicates a poorer quality of life.
Measured: Baseline (before treatment), immediately after the 9th（day5） stimulation sessions (each session lasts for 30 min), and at the two-week and four-week follow-ups after the completion of treatment.
Change in Score on the Hamilton Depression Rating Scale (HAMD)
Change in Score on the Hamilton Depression Rating Scale (HAMD) is used to evaluate the severity of depressive symptoms. This assessment consists of 17 items with a total score range from 0 to 54 points; a higher score indicates a worse outcome. With common clinical thresholds (e.g., 0-7 = Normal, 8-16 = Mild Depression, 17-23 = Moderate Depression, ≥24 = Severe Depression).
Measured: Baseline (before treatment), immediately after the 9th（day5） stimulation sessions (each session lasts for 30 min), and at the two-week and four-week follow-ups after the completion of treatment.
Change in Score on the Hamilton Anxiety Rating Scale (HAMA)
The Hamilton Anxiety Rating Scale (HAMA) is a 14-item scale to evaluate the severity of anxiety symptoms, where each item is rated on a scale from 0 to 4. The HAMA total score ranges from 0 to 56, with lower scores indicating fewer anxiety symptoms.
Measured: Baseline (before treatment), immediately after the 9th（day5） stimulation sessions (each session lasts for 30 min), and at the two-week and four-week follow-ups after the completion of treatment.
Change in Score on the Visual Analog Scale for Fatigue (VAS-Fatigue)
Visual Analog Scale for Fatigue is used to quantify the subjective intensity of fatigue. The score typically ranges from 0 to 10 cm, where 0 represents "no fatigue" and 10 represents "the worst imaginable fatigue. A higher score indicates greater fatigue severity
Measured: Baseline (before treatment), immediately after the 9th（day5） stimulation sessions (each session lasts for 30 min), and at the two-week and four-week follow-ups after the completion of treatment.
Change in Score on the Pittsburgh Sleep Quality Index (PSQI)
the Pittsburgh Sleep Quality Index (PSQI) is used to assess sleep quality and disturbances over the past month. With changes in the score reflecting the multiple factors of daily function. Each component is scored from 0 to 3. The global PSQI score is the sum of the 7 component scores, ranging from 0 to 21 points. A higher total score indicates poorer sleep quality
Measured: Baseline (before treatment), immediately after the 9th（day5） stimulation sessions (each session lasts for 30 min), and at the two-week and four-week follow-ups after the completion of treatment.
Changes in Magnetoencephalography (MEG)
Magnetoencephalography (MEG) is a non-invasive, functional neuroimaging technique that measures the magnetic fields generated by the electrical activity of neurons in the brain. It provides direct, real-time (millisecond resolution) information about brain function. With changes in MEG reflecting the brain functional connectivity before and after treatment
Measured: Baseline (before treatment) and immediately after the 9th（day5） stimulation sessions (each session lasts for 30 min).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start20 Jan 2026
- Primary completion20 Jun 2026
- Study completion20 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tang Zhouping
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tang Zhouping, Tongji Hospital
- Investigators
- Zhouping Tang, PhD MD, Principal investigator, Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 450001
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07361250
- Sponsor's protocol ID
- 202511129
- Acronym
- TIS-STN-PD1
- Status last verified
- Jul 2026
- First submitted
- 14 Dec 2025
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yang C, Xu Y, Du Y, Shen X, Li T, Chen N, Zhu Y, Li L, Huang L, Lu J, Qian Z, Wang Z, Zhou J, Ziemann U, Zhang C, Liu Y. Transcranial temporal interference subthalamic stimulation for treating motor symptoms in Parkinson's disease: A pilot study. Brain Stimul. 2024 Nov-Dec;17(6):1250-1252. doi: 10.1016/j.brs.2024.10.012. Epub 2024 Oct 30. No abstract available.
PubMed 39486623Violante IR, Alania K, Cassara AM, Neufeld E, Acerbo E, Carron R, Williamson A, Kurtin DL, Rhodes E, Hampshire A, Kuster N, Boyden ES, Pascual-Leone A, Grossman N. Non-invasive temporal interference electrical stimulation of the human hippocampus. Nat Neurosci. 2023 Nov;26(11):1994-2004. doi: 10.1038/s41593-023-01456-8. Epub 2023 Oct 19.
PubMed 37857775Grossman N, Bono D, Dedic N, Kodandaramaiah SB, Rudenko A, Suk HJ, Cassara AM, Neufeld E, Kuster N, Tsai LH, Pascual-Leone A, Boyden ES. Noninvasive Deep Brain Stimulation via Temporally Interfering Electric Fields. Cell. 2017 Jun 1;169(6):1029-1041.e16. doi: 10.1016/j.cell.2017.05.024.
PubMed 28575667
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of Transcranial Temporal Interference Stimulation (TIS) Targeting the Subthalamic Nucleus (STN) in Parkinson's Disease: A Single-Center, Prospective, Double-Blind, Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07361250
- Acronym / sponsor ID
- TIS-STN-PD1 / 202511129
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease, Temporal Interference Stimulation, Subthalamic Nucleus (STN)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Tang ZhoupingUniversity, hospital or other
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- 20 Jun 2026 (actual)
- Study completion
- 20 Jun 2026 (actual)
- First posted
- 22 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.
This is a single-center, prospective, double-blind, randomized controlled trial to evaluate the efficacy and safety of transcranial temporal interference stimulation targeting the subthalamic nucleus in patients with Parkinson's disease. It plans to enroll 20 eligible participants who will be randomly assigned in a 1:1 ratio to either the active TIS stimulation group or the sham stimulation group.
Detailed description
Parkinson's disease is a progressive neurodegenerative disorder characterized by motor dysfunction.
Temporal Interference Stimulation (TIS) is a non-invasive deep brain stimulation technique. Its core principle involves placing two pairs of transcranial stimulation electrodes on the scalp surface, each delivering high-frequency currents with slight differences. Since the human cerebral cortex does not respond to high-frequency currents, when these two currents intersect in the deep brain (i.e., the target area), they generate a low-frequency interference wave-similar to tACS-with a frequency equal to the difference between the two currents. This enables selective modulation of deep brain regions while minimizing activation of the superficial cortex. Additionally, a breakthrough aspect of TIS is its ability to flexibly adjust the stimulation target location by modifying electrode positions and current ratios. This makes it highly suitable for future clinical applications in regulating deep brain nuclei and developing personalized diagnosis and treatment plans for Parkinson's disease (PD) patients. The technology offers a non-invasive method to alter neuronal activity in deep brain nuclei and has shown promise in improving PD motor symptoms in prior proof-of-concept studies, thereby providing a potential treatment for PD motor symptoms.
In animal models, TIS has been demonstrated to have the potential to modulate the activity of brain regions closely associated with PD motor symptoms, such as the subthalamic nucleus and globus pallidus. Preliminary clinical studies have shown that TIS stimulation of the unilateral STN in PD patients resulted in alleviation of motor symptoms such as tremor and bradykinesia before and after treatment . A recent exploratory study on TIS stimulation of the right GPi also confirmed that TIS is feasible and safe for alleviating mild PD motor symptoms, particularly bradykinesia and tremor. Compared to the right side, motor symptoms (especially bradykinesia) on the left side showed more significant improvement. PD patients with more severe bradykinesia and tremor before stimulation experienced greater improvement after TIS. Current research findings suggest that TIS has the potential to improve PD motor symptoms. However, in these two studies, some patients did not respond to TIS stimulation. Although preliminary data support the therapeutic potential of TIS for PD motor symptoms, there is still a lack of large-sample, randomized controlled, and systematic studies targeting different brain regions and parameter systems. Therefore, there is an urgent need to conduct standardized clinical trials to evaluate the optimal stimulation parameters, target selection, efficacy persistence, and safety of TIS, providing evidence-based support for its further promotion and application.
This study employs a single-center, prospective, randomized, double-blind, sham-controlled design to evaluate the efficacy and safety of TIS targeting the subthalamic nucleus in Parkinson's disease patients. The study protocol involves structural MRI scanning for all participants to establish individualized computational models, with neuronavigation techniques determining optimal electrode placement. Participants are randomized to either the active stimulation group (using 2000/2130 Hz dual-frequency configuration) or the sham control group (using 2000/2000 Hz configuration). All treatment sessions are conducted during patients' "ON" medication state, administered twice daily for 30 minutes over five consecutive days. Assessment is performed through blinded evaluation by raters unaware of group allocation using standardized scales at predetermined time points. The entire process follows structured data collection and safety monitoring protocols. This study aims to systematically evaluate the therapeutic effects and safety profile of TIS for motor symptoms in Parkinson's disease, providing an evidence base for the clinical application of this novel neuromodulation approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active TIS stimulation | Experimental | Device: NervioX-1000Participants in this group will receive transcranial temporal interference stimulation targeting the subthalamic nucleus using a frequency pair of 2000 Hz and 2130 Hz. Stimulation will be delivered twice daily at the same time for 30 minutes per session over five consecutive days（only once on the 5th day）. Stimulation intensity will be individually titrated starting from a low level and gradually increased to the maximum tolerable level. All treatments will be administered during the participant's medication "on" state. |
| Sham stimulation | Sham comparator | Device: NervioX-1000Participants in this group will receive sham stimulation using a frequency pair of 2000 Hz and 2000 Hz. Stimulation will be administered twice daily for 30 minutes per session over five consecutive days（only once on the 5th day） during the participant's medication "on" state, with current intensity individually titrated in the same manner as the active group. The sham protocol includes cutaneous sensation simulation during a 30-second ramp-up and ramp-down phase to maintain participant blinding, but does not generate an effective interference field in the deep brain target. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older, no gender restriction;
- Diagnosis of primary Parkinson's disease according to MDS criteria: specifically, the patient must (a) exhibit parkinsonism (bradykinesia + resting tremor/rigidity); (b) not meet any of the MDS absolute exclusion criteria; and (c) meet at least two MDS supportive criteria.
- Disease duration ≥1 year, stable condition;
- Hoehn-Yahr stage between 1.5 and 3, with a stable dose of levodopa or other dopaminergic medications for at least 4 weeks, responsive to levodopa-like medications, and no changes to the treatment regimen during the trial;
- Good compliance, with the patient and family willing to participate in the clinical trial, voluntarily sign the informed consent form, attend regular treatments and follow-ups, and accurately complete evaluation tasks.
Key exclusion criteria (13 listed)
- Severe cognitive impairment, resulting in poor compliance due to dementia, and/or inability to sign the informed consent form;
- History of severe psychiatric disorders, patients with a Hamilton Depression Scale (HAMD) score >24;
- History of taking antipsychotic drugs, antidepressants, or other medications that may affect dopamine levels;
- History of seizures within the last year or a family history of epilepsy;
- Unable to complete MRI scanning (e.g., due to claustrophobia, or having metal implants in the body);
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 |
|---|---|---|
| NervioX-1000All participants will receive individualized T1-weighted MRI scans for computational modeling to determine optimized electrode placement and stimulation parameters for transcranial temporal interference stimulation targeting the subthalamic nucleus. The stimulation protocol is designed to generate a focal 130 Hz interference field in the target region while minimizing cortical activation. Parameters including electrode positions and current intensity are customized based on each participant's unique neuroanatomy to ensure precise and tailored neuromodulation. | Device | Active TIS stimulation, Sham stimulation |
Primary outcome
Change in Score on Part III (Motor Examination) of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Time frame: Baseline (before treatment), immediately after the 1st（day1）, 5th（day3）, and 9th（day5） stimulation sessions (each session lasts for 30 min), and at the two-week and four-week follow-ups after the completion of treatment.
The motor function of patients was assessed using Part III of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS-III), which has a total score range of 0 to 132. In this scale, a higher score indicates greater severity of motor symptoms and therefore a worse outcome, with 0 representing no impairment and 132 representing the most severe impairment. Changes in the score reflect the degree of improvement in motor function.
9 secondary outcomes
MDS-UPDRS Scale Part I Non-Motor Function Score Changes
Time frame: Baseline (before treatment), immediately after the 9th（day5） stimulation sessions (each session lasts for 30 min), and at the two-week and four-week follow-ups after the completion of treatment.
MDS-UPDRS Scale Part II: Activities of Daily Living Score Changes
Time frame: Baseline (before treatment), immediately after the 9th（day5） stimulation sessions (each session lasts for 30 min), and at the two-week and four-week follow-ups after the completion of treatment.
MDS-UPDRS Scale Part IV: Motor Fluctuations, Dyskinesias, and Dystonia Score Changes
Time frame: Baseline (before treatment), immediately after the 9th（day5） stimulation sessions (each session lasts for 30 min), and at the two-week and four-week follow-ups after the completion of treatment.
Change in Score on the 39-item Parkinson's Disease Questionnaire (PDQ-39)
Time frame: Baseline (before treatment), immediately after the 9th（day5） stimulation sessions (each session lasts for 30 min), and at the two-week and four-week follow-ups after the completion of treatment.
Change in Score on the Hamilton Depression Rating Scale (HAMD)
Time frame: Baseline (before treatment), immediately after the 9th（day5） stimulation sessions (each session lasts for 30 min), and at the two-week and four-week follow-ups after the completion of treatment.
Change in Score on the Hamilton Anxiety Rating Scale (HAMA)
Time frame: Baseline (before treatment), immediately after the 9th（day5） stimulation sessions (each session lasts for 30 min), and at the two-week and four-week follow-ups after the completion of treatment.
Change in Score on the Visual Analog Scale for Fatigue (VAS-Fatigue)
Time frame: Baseline (before treatment), immediately after the 9th（day5） stimulation sessions (each session lasts for 30 min), and at the two-week and four-week follow-ups after the completion of treatment.
Change in Score on the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline (before treatment), immediately after the 9th（day5） stimulation sessions (each session lasts for 30 min), and at the two-week and four-week follow-ups after the completion of treatment.
Changes in Magnetoencephalography (MEG)
Time frame: Baseline (before treatment) and immediately after the 9th（day5） stimulation sessions (each session lasts for 30 min).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Results publication: PubMed 39486623Yang C, Xu Y, Du Y, Shen X, Li T, Chen N, Zhu Y, Li L, Huang L, Lu J, Qian Z, Wang Z, Zhou J, Ziemann U, Zhang C, Liu Y. Transcranial temporal interference subthalamic stimulation for treating motor symptoms in Parkinson's disease: A pilot study. Brain Stimul. 2024 Nov-Dec;17(6):1250-1252. doi: 10.1016/j.brs.2024.10.012. Epub 2024 Oct 30. No abstract available.
- Results publication: PubMed 37857775Violante IR, Alania K, Cassara AM, Neufeld E, Acerbo E, Carron R, Williamson A, Kurtin DL, Rhodes E, Hampshire A, Kuster N, Boyden ES, Pascual-Leone A, Grossman N. Non-invasive temporal interference electrical stimulation of the human hippocampus. Nat Neurosci. 2023 Nov;26(11):1994-2004. doi: 10.1038/s41593-023-01456-8. Epub 2023 Oct 19.
- Results publication: PubMed 28575667Grossman N, Bono D, Dedic N, Kodandaramaiah SB, Rudenko A, Suk HJ, Cassara AM, Neufeld E, Kuster N, Tsai LH, Pascual-Leone A, Boyden ES. Noninvasive Deep Brain Stimulation via Temporally Interfering Electric Fields. Cell. 2017 Jun 1;169(6):1029-1041.e16. doi: 10.1016/j.cell.2017.05.024.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Parkinson Disease
RecruitingPhase 2
A Study to Evaluate the Effectiveness of Two Doses of AP-472 as Adjunctive Therapy to Levodopa in Parkinson's Disease (PD) Participants With Motor Fluctuations
Parkinson Disease
RecruitingEarly Phase 1
[18F]ACI-15916 PET in α-synucleinopathies
Parkinson's Disease (PD), Multiple System Atrophy (MSA)
Not yet recruitingPhase 4
Behavioral and/or Mirabegron to Treat Urinary Symptoms in Parkinson Disease
Overactive Bladder, Parkinson Disease
RecruitingPhase 2
A Study to Evaluate the Efficacy, PK, Safety, and Tolerability of VIM0423 in Adults With Parkinson's Disease Tremor Insufficiently Responsive to Dopaminergic Therapy
PARKINSON DISEASE (Disorder)
RecruitingObservational study
Parkinson's Disease in Type 1 Gaucher Disease
Parkinson Disease (PD), Type 1 Gaucher Disease
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. This study is not recruiting at the moment.
Zhouping Tang, PhD MD principal investigator
Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 450001
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NervioX-1000 in people with Parkinson Disease, run by Tang Zhouping 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 5 inclusion and 13 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: finished, as of the sponsor's last update on 21 Jul 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Score on Part III (Motor Examination) of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (time frame: Baseline (before treatment), immediately after the 1st（day1）, 5th（day3）, and 9th（day5） stimulation sessions (each session lasts for 30 min), and at the two-week and four-week follow-ups after the completion of treatment.). 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 NCT07361250, which also lists 3 linked publications.
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 21 Jul 2026.