This is a single-center, prospective, double-blind, randomized controlled trial to evaluate the efficacy and safety of transcranial temporal interference stimulation targeting the subthalamic nucleus in patients with Parkinson's disease. It plans to enroll 20 eligible participants who will be randomly assigned in a 1:1 ratio to either the active TIS stimulation group or the sham stimulation group.
Age 18 years or older, no gender restriction;
Diagnosis of primary Parkinson's disease according to MDS criteria: specifically, the patient must (a) exhibit parkinsonism (bradykinesia + resting tremor/rigidity); (b) not meet any of the MDS absolute
Disease duration ≥1 year, stable condition;
Hoehn-Yahr stage between 1.5 and 3, with a stable dose of levodopa or other dopaminergic medications for at least 4 weeks, responsive to levodopa-like medications, and no changes to the treatment regimen during the trial;
Good compliance, with the patient and family willing to participate in the clinical trial, voluntarily sign the informed consent form, attend regular treatments and follow-ups, and accurately complete evaluation tasks.
Severe cognitive impairment, resulting in poor compliance due to dementia, and/or inability to sign the informed consent form;
Tang Zhouping
Lead sponsor
Tongji Hospital
Sponsor institution