Remotely Supervised Home-based Transcranial Temporal Interference Stimulation on Motor Symptoms 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

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

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.