Subthalamic Nucleus (STN)-Targeted Transcranial Temporal Interference Stimulation (TIS) for Parkinson's Disease: Efficacy and Safety From a Single-Center, Prospective, Double-Blind Randomized Controlled Trial

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.

Inclusion Criteria: 1. Age 18 years or older, no gender restriction; 2. 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 exclusion criteria; and (c) meet at least two MDS supportive criteria. 3. Disease duration ≥1 year, stable condition; 4. 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; 5. 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. Exclusion Criteria: 1. Severe cognitive impairment, resulting in poor compliance due to dementia, and/or inability to sign the informed consent form; 2. History of severe psychiatric disorders, patients with a Hamilton Depression Scale (HAMD) score \>24; 3. History of taking antipsychotic drugs, antidepressants, or other medications that may affect dopamine levels; 4. History of seizures within the last year or a family history of epilepsy; 5. Unable to complete MRI scanning (e.g., due to claustrophobia, or having metal implants in the body); 6. Patients with severe heart, liver, or kidney diseases, severe hypertension, and severe orthostatic hypotension that affect their health condition; 7. Patients with severe diabetes or severe cardio-cerebrovascular diseases that affect their health condition; 8. Diagnosed with malignant tumors; 9. Contraindications for non-invasive electrical stimulation, such as intracranial active implants (regardless of whether they are turned on) or passive implants that may affect electrical stimulation treatment, those who have undergone stereotactic deep brain stimulation or neurotomy, or have had any surgical procedures within the last six months that the investigator believes may affect this trial; 10. History of traumatic brain injury; 11. Pregnant women or women planning to become pregnant; 12. Subjects currently participating in other clinical trials or have participated in other clinical research within the last three months without reaching primary endpoints; 13. Patients deemed unsuitable to participate in this clinical study by the investigators.