Not Yet RecruitingNot Applicable

Effects of Targeted Temporal Interference Stimulation of Cerebellar Nuclei on Tremor and Gait Disturbance in Parkinson's Disease Patients

China50 participantsStarted 2026-08-19

Plain-language summary

The goal of this clinical trial is to explore the effects of cerebellar nuclei TIS stimulation on improving tremor and gait disorders in PD patients. Through randomized double-blind grouping, the differences in efficacy between TIS intervention and sham stimulation intervention for tremor and gait disorders in PD patients will be compared.

Who can participate

Age range

50 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: * 1.Aged 50 years or older; * 2.Confirmed diagnosis of idiopathic Parkinson's disease (IPD) according to the 2015 MDS diagnostic criteria, with tremor and gait disturbance; * 3.Disease duration ≥2 years after diagnosis, stable condition, and ability to cooperate with study assessment and intervention; * 4.Stable medication dosage for at least 4 weeks prior to the trial; * 5.Good response to Levodopa therapy; * 6.Capable of independent walking (without assistive devices) for at least 5 minutes and able to complete gait testing independently. * 7.Signed informed consent form, with the participant or their legal guardian able to understand and willing to participate in this study. Exclusion Criteria: * 1.History or confirmed diagnosis of severe mental disorders, such as depression, anxiety disorders, schizophrenia spectrum disorders, and bipolar disorder; * 2.The subject has clinically defined neurological conditions (assessed through self-report), including but not limited to: any disease potentially associated with increased intracranial pressure, space-occupying lesions, stroke history, transient ischemic attack (TIA) within the past two years, cerebral aneurysm, dementia, multiple sclerosis; * 3.Severe cognitive impairment, Mini-Mental State Examination (MMSE) score \<22, or inability to independently complete questionnaires; * 4.Inability to read or understand Chinese; * 5.Use of other neuromodulatory therapies within the past 3 months; * 6.Presence o…

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.

1This trial uses something called 'targeted temporal interference stimulation' aimed at the cerebellar nuclei — can you explain in plain terms what that means physically, and whether stimulating that part of the brain is considered safe based on what's currently known?
2The trial is listed as 'not yet recruiting' — given where my Parkinson's symptoms are right now, does it make sense to wait for this study to open, or should we be pursuing other treatment options in the meantime?
3The study is measuring tremor and gait changes using EMG readings and a specialized gait device — how would my current tremor and walking difficulties be assessed to know if those outcomes are even relevant to my specific situation?
4Since this is listed as Phase NA, which often applies to device or non-drug studies, what does that mean for how much safety and effectiveness data already exists for this type of brain stimulation compared to more established options like deep brain stimulation?
5Are there standard Parkinson's treatments — such as medication adjustments or physical therapy — that you'd recommend trying first before considering an experimental stimulation study like this one?

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

Changes of electromyographic tremor index

Timeframe: Baseline, at the end of the 19-day post-treatment, 30-day follow up.

Changes of Zhenluo Gait Device evaluation

Timeframe: Baseline, at the end of the 19-day post-treatment, 30-day follow up.

Trial details

NCT IDNCT07384442

SponsorYangPan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Yang Pan

+8613952098253 panyang.zn@whu.edu.cn

View on ClinicalTrials.gov More Parkinson's Disease trials