Temporal Interference Noninvasive Deep Brain Stimulation for Idiopathic Parkinson's Disease and P… (NCT07698236) | Clinical Trial Compass
By InvitationNot Applicable
Temporal Interference Noninvasive Deep Brain Stimulation for Idiopathic Parkinson's Disease and Parkinsonian Syndromes: Effects and Target Exploration
China100 participantsStarted 2026-07-03
Plain-language summary
This study aims to explore the therapeutic effects of noninvasive deep brain electrical stimulation using temporal interference principles (Temporal Interference Stimulation, TIS) on both motor and non-motor symptoms in patients with idiopathic Parkinson's disease and Parkinsonian syndromes, and to investigate strategies for optimal stimulation target selection. A prospective, single-center, double-blind, randomized, crossover design will be implemented. Participants will be recruited from outpatient and inpatient departments of Ruijin Hospital, Shanghai Jiao Tong University School of Medicine. The primary hypothesis is that TIS will significantly improve motor symptoms in patients with Parkinson's disease and Parkinsonian syndromes. The primary outcome measure will be the change in the MDS-UPDRS Part III score from baseline to post-stimulation.
This study is expected to provide direct evidence supporting the clinical application and target selection strategies of noninvasive deep brain stimulation for the treatment of Parkinson's disease and Parkinsonian syndromes.
Who can participate
Age range
40 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Aged 40 to 80 years, diagnosed with idiopathic Parkinson's disease or Parkinsonian syndromes according to the Movement Disorder Society (MDS) diagnostic criteria.
. Receiving stable doses of levodopa or other dopaminergic medications for at least 4 weeks prior to enrollment, with a documented response to levodopa; medication regimen must remain unchanged during the study.
. Hoehn and Yahr (H\&Y) stage ≤ 3 in the "ON" medication state.
. Normal cognitive function, defined as a Mini-Mental State Examination (MMSE) score ≥ 24.
. Able to maintain and cooperate with Parkinson's disease symptom diaries.
. Signed written informed consent.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Efficacy of temporal interference stimulation (TIS) on motor symptoms in patients with idiopathic Parkinson's disease and Parkinsonian syndromes
Timeframe: Baseline, 3 days after sham stimulation, and 3 days after active stimulation.