Home-based remote temporal interference stimulation for motor problems in Parkinson's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Shanghai University of Sport
  Shanghai, Shanghai Municipality, China Recruiting
• Shanghai University of Sport
  Shanghai, Shanghai Municipality, China Not yet recruiting

Study contacts

• Study coordinator: Yu Liu, Prof.
• Email: yuliu@sus.edu.cn
• Phone: +86 21 65507351

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.