Temporal interference stimulation targeting the internal globus pallidus to improve movement in Parkinson's disease
Effects and Mechanisms of Non-invasive Deep Brain Stimulation in Patients With Parkinson's Disease
Researchers will try transcranial temporal interference stimulation (TIS) aimed at the brain's internal globus pallidus to see if it reduces motor symptoms in people with Parkinson's disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 50 Years to 80 Years |
| Sex | All |
| Sponsor | Shanghai University of Sport Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT07309198 on ClinicalTrials.gov |
What this trial studies
This randomized interventional study compares active transcranial temporal interference stimulation (TIS) of the internal globus pallidus (GPi) with sham stimulation. Participants receive 10 sessions of active or sham TIS over two weeks, with motor assessments during treatment and follow-ups at 2, 4, and 8 weeks after the last session. The study also records brain activity changes linked to any motor improvements using neuroimaging or electrophysiologic measures. Eligibility focuses on people with idiopathic Parkinson's disease who can walk unassisted, are on stable medications, and do not have dementia.
Who should consider this trial
Good fit: Adults with physician-diagnosed idiopathic Parkinson's disease, Hoehn and Yahr stage 1.5–3, able to walk without assistance, on stable antiparkinsonian medication, and with MoCA ≥ 21 are ideal candidates.
Not a fit: People with dementia, MRI or stimulation contraindications (like metal implants), recent orthopedic problems affecting movement, or who take excluded psychiatric or dopamine-modulating medications are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, TIS could offer a noninvasive treatment that lessens Parkinson's motor symptoms for weeks after a short course of sessions.
How similar studies have performed: Temporal interference stimulation is a novel approach with encouraging preclinical data but only limited early human evidence, so clinical efficacy remains largely unproven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * A physician-diagnosed idiopathic Parkinson's disease (PD) according to the Movement Disorder Society (MDS) diagnostic criteria, with onset after the age of 40. * Stable antiparkinsonian medication regimen, including levodopa-containing therapy, unchanged for at least 4 weeks before and during the trial. * Hoehn and Yahr (H\&Y) stages 1.5 to 3 and ability to walk unassisted. * Absence of dementia, defined as a Montreal Cognitive Assessment (MoCA) score ≥ 21. Exclusion Criteria: * Any contraindication for MRI or transcranial temporal interference stimulation (TIS), including claustrophobia, metallic implants in the head or heart, or a history of electroconvulsive therapy. * Current use of antipsychotic, antidepressant, or other dopamine-modulating medications. * Presence of orthopedic conditions that may interfere with motor assessments, such as osteoarthritis or recent orthopedic surgery (within the past 6 months). * History of physician-diagnosed major psychiatric illness. * Physician-diagnosed cardiovascular risks that could contraindicate exercise or study participation. * Prior history of deep brain stimulation (DBS) surgery.
Where this trial is running
Shanghai, Shanghai Municipality
- Shanghai University of Sport — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Yu Liu, PhD
- Email: yuliu@sus.edu.cn
- Phone: +86 21 65507351
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.