NCT07518290 Remotely Supervised Home-based Transcranial Temporal Interference Stimulation on Motor Symptoms in Parkinson's Disease
| NCT ID | NCT07518290 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai University of Sport |
| Condition | PARKINSON DISEASE (Disorder) |
| Study Type | INTERVENTIONAL |
| Enrollment | 68 participants |
| Start Date | 2026-04-04 |
| Primary Completion | 2028-01-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 68 participants in total. It began in 2026-04-04 with a primary completion date of 2028-01-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07518290 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 80 Years, studying PARKINSON DISEASE (Disorder). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07518290 currently recruiting?
Yes, NCT07518290 is actively recruiting participants. Contact the research team at yuliu@sus.edu.cn for enrollment information.
Where is the NCT07518290 trial being conducted?
This trial is being conducted at Shanghai, China, Shanghai, China.
Who is sponsoring the NCT07518290 clinical trial?
NCT07518290 is sponsored by Shanghai University of Sport. The trial plans to enroll 68 participants.
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