Subthalamic Nucleus-Targeted Transcranial Temporal Interference Stimulation for Motor and Non-Motor Symptoms in Parkinson's Disease

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Parkinson's Disease (PD)

In brief

Transcranial temporal interference stimulation (tTIS) is a non-invasive deep brain stimulation method. This study aims to comprehensively explore the efficacy and safety of bilateral subthalamic nucleus (STN) tTIS on motor and non-motor symptoms in patients with Parkinson's disease (PD).

Key facts

Study ID

NCT07625540

Run by

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

People needed

32

Starts

2026-05-20

Expected to finish

2027-04-01

Last updated by the study team

2026-06-04

Who can join

Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged 50-85 years, male or female.
• Diagnosed with "clinically established" or "clinically probable" Parkinson's disease according to the 2015 MDS Clinical Diagnostic Criteria for Parkinson's Disease.
• Hoehn-Yahr stage ≥ 2, and judged by the investigator to be able to cooperate in completing scale-based assessments and MRI examinations.
• Stable regimen of anti-Parkinsonian medication for at least 4 weeks before enrollment, and agreement to maintain a stable regimen during the main study phase unless medically necessary to change.
• Written informed consent signed by the study participant.

You may not qualify if…

• Non-primary Parkinson's disease or other parkinsonism / atypical parkinsonism.
• Previous receipt of invasive neuromodulation therapies such as deep brain stimulation (DBS) or other intracranial implantation/stereotactic brain surgery.
• Presence of contraindications or high-risk conditions for transcranial electrical stimulation (e.g., incompatible metal implants/implantable electrical stimulation devices, etc.), or judged by the investigator as unsuitable to receive transcranial electrical stimulation.
• Receipt of non-invasive neuromodulation interventions such as transcranial magnetic stimulation or transcranial electrical stimulation within the past six months.
• Presence of contraindications to MRI or inability to tolerate MRI examination.
• Significant cognitive impairment or severe psychiatric symptoms that prevent completion of assessments or result in poor compliance.
• New initiation or dose adjustment of medications or treatments that significantly affect sleep architecture/consciousness status within the past 4 weeks.
• History of epilepsy.
• Pregnancy or breastfeeding.
• Any other condition judged by the investigator as unsuitable for participation in the study.

Where it is running

• Shanghai General Hospital — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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