Parkinson Disease (PD)NCT07827456
MRI-Guided Temporal Interference Stimulation for Parkinson's Disease
A study testing Temporal Interference Stimulation (130 Hz) in people with Parkinson Disease (PD), run by Tongji Hospital.
Trial summary
This study aims to evaluate the efficacy and safety of tTIS treatment in patients with Parkinson's disease (PD). The study will enroll eligible PD patients and randomly assign them to two groups: Group A will first receive combined GPi and STN stimulation, followed by GPi stimulation one week later; Group B will first… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Parkinson Disease (PD)
- What is being tested?
- Temporal Interference Stimulation (130 Hz)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2026to 10 Jun 2027
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years (inclusive), any gender.
- Diagnosis of idiopathic Parkinson's disease according to the Chinese diagnostic criteria for Parkinson's disease (2016 edition).
- Hoehn and Yahr stage 2-4 (inclusive) during the "off" state.
- Documented response to levodopa (>33% improvement), with a stable anti-parkinsonian medication regimen for at least 4 weeks prior to screening, and no dose adjustments during the study.
- Voluntary signed informed consent, and ability to understand and comply with the study protocol to complete the study.
- No significant cognitive impairment (Montreal Cognitive Assessment [MoCA] score ≥21).
Who cannot join
- Inability or unwillingness to comply with the study protocol and/or inability to provide written informed consent;
- Presence of a significant medical condition that may interfere with study procedures or confound the assessment of study endpoints;
- Presence of a severe psychiatric disorder that may affect the participant's ability to comply with the study protocol;
- A history of psychiatric disorders or current severe depression or anxiety;
- Presence of metallic implants in the brain;
- Known pregnancy or current breastfeeding;
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- Severe neurological disorders, such as a brain tumor;
- Severe cardiac disease, including the presence of an implanted cardiac pacemaker;
- Scalp lesions, inflammation, infection, active bleeding, or an increased bleeding tendency;
- Any other current medical condition for which the use of transcranial electrical stimulation may pose an unacceptable risk;
- A history of epilepsy or structural brain lesions, including severe cerebral atrophy or cerebrovascular disease;
- Inability to undergo magnetic resonance imaging (MRI), such as because of claustrophobia or implanted metallic devices;
- Inability to cooperate with or complete the required assessments; or any other condition that, in the investigator's judgment, makes the individual unsuitable for participation in the study.
About this study
Official title: Efficacy of MRI-Guided Transcranial Temporal Interference Electrical Stimulation (tTIS) Modulation for Parkinson's Disease: An Exploratory Study
This study aims to evaluate the efficacy and safety of tTIS treatment in patients with Parkinson's disease (PD). The study will enroll eligible PD patients and randomly assign them to two groups: Group A will first receive combined GPi and STN stimulation, followed by GPi stimulation one week later; Group B will first receive GPi stimulation, followed by combined GPi and STN stimulation one week later. The MDS-UPDRS Part III will be assessed at pre-stimulation baseline, immediately after stimulation, and at 30 and 60 minutes post-stimulation for each session, in order to evaluate and compare the therapeutic effects of tTIS targeting GPi alone versus combined GPi and STN stimulation on motor symptoms in PD patients, and to assess the differential efficacy of tTIS at different targets among PD patients with varying symptoms.
- Conditions
- Parkinson Disease (PD)
- Being tested
- Temporal Interference Stimulation (130 Hz)
- Keywords
- Parkinson Disease, Temporal Interference Stimulation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporal Interference Stimulation (130 Hz)Device
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 |
|---|---|---|
| Experimental group A | Active comparator | Patients in this group receive individualized targeting based on MRI head modeling. During the medication-off period, they first undergo 130 Hz combined GPi and STN stimulation (GPi+STN), and one week later, they undergo 130 Hz GPi stimulation alone. Receives: Device: Temporal Interference Stimulation (130 Hz) |
| Experimental group B | Active comparator | Patients in this group receive individualized targeting based on MRI head modeling. During the medication-off period, they first undergo 130 Hz GPi stimulation alone, and one week later, they undergo 130 Hz combined GPi and STN stimulation (GPi+STN). Receives: Device: Temporal Interference Stimulation (130 Hz) |
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: at pre-stimulation baseline, immediately after stimulation, and at 30 and 60 minutes post-stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start15 Sep 2026 (estimated)
- Primary completion10 Jun 2027 (estimated)
- Study completion10 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson Disease (PD)Studies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tang Zhouping, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07827456
- Sponsor's protocol ID
- 20260599
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of MRI-Guided Transcranial Temporal Interference Electrical Stimulation (tTIS) Modulation for Parkinson's Disease: An Exploratory Study
- ClinicalTrials.gov ID
- NCT07827456
- Acronym / sponsor ID
- 20260599
- Conditions
- Parkinson Disease (PD)
- Keywords
- Parkinson Disease, Temporal Interference Stimulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 10 Jun 2027 (estimated)
- Study completion
- 10 Jun 2027 (estimated)
- First posted
- 18 Sep 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 study aims to evaluate the efficacy and safety of tTIS treatment in patients with Parkinson's disease (PD). The study will enroll eligible PD patients and randomly assign them to two groups: Group A will first receive combined GPi and STN stimulation, followed by GPi stimulation one week later; Group B will first receive GPi stimulation, followed by combined GPi and STN stimulation one week later. The MDS-UPDRS Part III will be assessed at pre-stimulation baseline, immediately after stimulation, and at 30 and 60 minutes post-stimulation for each session, in order to evaluate and compare the therapeutic effects of tTIS targeting GPi alone versus combined GPi and STN stimulation on motor symptoms in PD patients, and to assess the differential efficacy of tTIS at different targets among PD patients with varying symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group A | Active comparator | Device: Temporal Interference Stimulation (130 Hz)Patients in this group receive individualized targeting based on MRI head modeling. During the medication-off period, they first undergo 130 Hz combined GPi and STN stimulation (GPi+STN), and one week later, they undergo 130 Hz GPi stimulation alone. |
| Experimental group B | Active comparator | Device: Temporal Interference Stimulation (130 Hz)Patients in this group receive individualized targeting based on MRI head modeling. During the medication-off period, they first undergo 130 Hz GPi stimulation alone, and one week later, they undergo 130 Hz combined GPi and STN stimulation (GPi+STN). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-75 years (inclusive), any gender.
- Diagnosis of idiopathic Parkinson's disease according to the Chinese diagnostic criteria for Parkinson's disease (2016 edition).
- Hoehn and Yahr stage 2-4 (inclusive) during the "off" state.
- Documented response to levodopa (>33% improvement), with a stable anti-parkinsonian medication regimen for at least 4 weeks prior to screening, and no dose adjustments during the study.
- Voluntary signed informed consent, and ability to understand and comply with the study protocol to complete the study.
Key exclusion criteria (13 listed)
- Inability or unwillingness to comply with the study protocol and/or inability to provide written informed consent;
- Presence of a significant medical condition that may interfere with study procedures or confound the assessment of study endpoints;
- Presence of a severe psychiatric disorder that may affect the participant's ability to comply with the study protocol;
- A history of psychiatric disorders or current severe depression or anxiety;
- Presence of metallic implants in the brain;
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 |
|---|---|---|
| Temporal Interference Stimulation (130 Hz)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. | Device | Experimental group A, Experimental group B |
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: at pre-stimulation baseline, immediately after stimulation, and at 30 and 60 minutes post-stimulation
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.
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 21 Sep 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Temporal Interference Stimulation (130 Hz) in people with Parkinson Disease (PD), run by Tongji 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 6 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: opening soon, as of the sponsor's last update on 21 Sep 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?
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: at pre-stimulation baseline, immediately after stimulation, and at 30 and 60 minutes post-stimulation). 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 21 Sep 2026.