STN-targeted non-invasive brain stimulation for Parkinson’s symptoms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, randomized, double-blind, sham-controlled trial in Parkinson’s disease. The study uses bilateral subthalamic nucleus-targeted transcranial temporal interference stimulation over 5 days, with follow-up assessments at 0, 10, and 30 days after the intervention. Real stimulation uses two carrier frequencies (2000/2130 Hz) for 20 minutes per side each day, with personalized electrode placement based on MRI and head modeling. The sham group undergoes the same procedures but receives only brief fade-in/fade-out currents to maintain blinding. Eligible participants are adults aged 50–85 with PD and stable medication regimens, while those with prior invasive neuromodulation or other parkinsonian syndromes are excluded.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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's running

• Shanghai General Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Xiaoying Zhu, MD
• Email: docxiaoying@163.com
• Phone: 86-13817659260

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.