Home-based remote temporal interference stimulation for motor problems in Parkinson's disease
Remotely Supervised Home-based Transcranial Temporal Interference Stimulation on Motor Symptoms in Parkinson's Disease: Protocol For a Double Blind Randomized Controlled Trial
This trial will test whether daily, remotely supervised home temporal interference brain stimulation can help movement problems like slowness, stiffness, and walking difficulty in people with Parkinson's disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 68 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | Shanghai University of Sport Academic / other |
| Locations | 2 sites (Shanghai, Shanghai Municipality and 1 other locations) |
| Trial ID | NCT07518290 on ClinicalTrials.gov |
What this trial studies
This randomized, sham-controlled interventional trial delivers daily home-based temporal interference stimulation (TIS) under remote supervision for 4 weeks, with participants randomized to active or sham stimulation. Participants will attend clinic visits at set time points for standardized motor assessments and complete online questionnaires about symptoms and quality of life. The study will monitor safety by recording adverse events and will check whether any benefits persist after treatment ends. Outcomes focus on changes in motor symptoms and the occurrence of treatment-related medical problems.
Who should consider this trial
Good fit: People aged 40–80 with a clinical diagnosis of Parkinson's disease, mild-to-moderate severity (Hoehn and Yahr 1.5–3), stable Parkinson medications, the ability to walk unaided for at least 2 minutes, and no contraindications to temporal interference stimulation are ideal candidates.
Not a fit: People with advanced disease, dementia or MoCA <21, deep brain stimulation, certain metal implants or pacemakers, other major neurological or psychiatric disorders, or severe orthopedic problems affecting gait are unlikely to benefit or are excluded from participation.
Why it matters
Potential benefit: If successful, this could provide a noninvasive, at-home treatment option to reduce slowness, stiffness, and walking problems in people with Parkinson's disease.
How similar studies have performed: Temporal interference stimulation is a novel approach with limited human data, while related noninvasive brain stimulation methods have shown mixed and generally modest effects in Parkinson's disease.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of Parkinson's disease according to established clinical criteria * Mild-to-moderate disease severity, defined as Hoehn and Yahr stage 1.5-3; * Age between 40 and 80 years; * Stable anti-parkinsonian medication regimen; * Ability to walk unaided for at least 2 minutes. Exclusion Criteria: * contraindications to TIs (e.g., metal implantation, pacemakers, etc.); * the use of DBS; * significant cognitive impairment as defined by the diagnosis of Alzheimer's disease or dementia, or Montreal Cognitive Assessment (MoCA) total score\<21, a recommended threshold for dementia in PD; * diagnosis of other neurological conditions such as multiple sclerosis, previous stroke; * report of severe lower-extremity arthritis, pain, or orthopedic problems significantly affecting gait; * physician-diagnosis of schizophrenia or other psychiatric illness; * an unwillingness to cooperate or participate in the study protocol. Eligible and interested participants will then be enrolled and complete baseline assessments before the randomization.
Where this trial is running
Shanghai, Shanghai Municipality and 1 other locations
- Shanghai University of Sport — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
- Shanghai University of Sport — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Yu Liu, Prof.
- Email: yuliu@sus.edu.cn
- Phone: +86 21 65507351
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.