Temporal interference stimulation in Parkinson's disease: STN vs GPi targets

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 randomized, participant- and outcome-assessor-blinded, parallel-group trial in adults with Parkinson's disease. Participants are randomized 1:1 to receive either STN-targeted or GPi-targeted temporal interference stimulation (TIS) for 20 minutes daily over 7 days. Motor function is measured with MDS-UPDRS Part III before and after each session, and resting-state fMRI and 64-channel EEG are recorded before the first session and after the final session to explore neural changes. Primary outcome is the change in MDS-UPDRS Part III from Day 1 before stimulation to Day 7, with secondary imaging and electrophysiological endpoints.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Adult males or females aged ≥40 years;
2. Diagnosis of idiopathic Parkinson's disease according to the UK Brain Bank criteria, with age of onset ≥40 years;
3. Previous or current treatment with dopamine replacement therapy (e.g., levodopa) with good response;
4. Hoehn and Yahr (H\&Y) stage 1.5-2.5;
5. Able to walk independently for at least 5 minutes without assistive devices;
6. No severe freezing of gait (FOG);
7. Disease duration ≥2 years since diagnosis, clinically stable, and able to comply with study assessments and interventions;
8. Stable medication regimen for at least 4 weeks prior to the study;
9. Signed informed consent form; subject or legal guardian is able to understand and willing to participate in this study.

Exclusion Criteria:

1. Presence of other neurological disorders that may affect the study (e.g., ...);
2. Mild cognitive impairment or above (MoCA ≤23);
3. Orthopedic or other medical conditions that may affect gait or balance;
4. Contraindications to MRI, such as claustrophobia;
5. History of antipsychotic, antidepressant, or other medications that may affect dopamine levels;
6. History of other severe psychiatric disorders;
7. History of epilepsy, traumatic brain injury, or implanted metallic devices in the brain or heart (e.g., stimulators, pacemakers) or other contraindications;
8. History of electroconvulsive therapy (ECT);
9. Currently participating in other gait- or balance-related intervention training;
10. Physician-diagnosed cardiovascular risk factors for exercise.

Where it's running

• Zhongnan Hospital of Wuhan University
  Wuhan, Hubei, China Recruiting

Study contacts

• Study coordinator: Yang Pan
• Email: panyang.zn@whu.edu.cn
• Phone: 13952098253

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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.