Remotely Supervised Home-based Transcranial Temporal Interference Stimulation on Motor Symptoms in Parkinson's Disease

StatusRecruiting
PhaseNot applicable
Started

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Record History

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  1. Primary endpoints: details revised at 1 of 2 entries
    • Enrollment increased: 68 → 98 participants
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 10 of 15 entries
  2. Re-verified, no change to tracked fieldsv3
  3. Recruitment opened
    • Study sites: 1 to 2
    v2
  4. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
The goal of this clinical trial is to learn if home-based temporal interference stimulation (TIS) works to improve motor symptoms in people with Parkinson's disease (PD). It will also learn about the safety of this treatment. The main questions it aims to answer are: 1. Does home-based TIS improve movement problems such as slow movement, stiffness, and walking difficulty? 2. Are the effects maintained after the treatment ends? 3. What medical problems (adverse events) occur during treatment? Researchers will compare active TIS to a sham treatment (a look-alike procedure that does not deliver active stimulation) to see if TIS works. Participants will: 1. Receive active TIS or sham stimulation once a day for 4 weeks at home under remote supervision 2. Visit the clinic at specific time points for movement assessments 3. Complete online questionnaires about symptoms and quality of life
Trial Details
NCT Number NCT07518290
Lead Sponsor Shanghai University of Sport
Conditions
(from sponsor)		 PARKINSON DISEASE (Disorder), Motor Symptoms
Related terms Parkinson Disease
Enrollment 98 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov