Study on the Efficacy of Temporal Interference Stimulation (TIS) for Parkinson's Disease (NCT07312279) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Study on the Efficacy of Temporal Interference Stimulation (TIS) for Parkinson's Disease
24 participantsStarted 2025-12-30
Plain-language summary
The primary objective of this clinical study is to evaluate the therapeutic efficacy of Temporal Interference Stimulation (TIS), a non-invasive deep brain stimulation technique, in patients with Parkinson's disease, and to further investigate its potential mechanisms of action. Although TIS offers lower stimulation intensity and precision compared to conventional Deep Brain Stimulation (DBS), it possesses the distinct advantage of being non-invasive. This study utilizes TIS to explore different stimulation targets analogous to those used in DBS for Parkinson's disease, thereby providing valuable insights for subsequent DBS surgical interventions. The findings will contribute preliminary exploratory evidence regarding the application of non-invasive deep brain stimulation technology in the treatment of Parkinson's disease.
Who can participate
Age range40 Years
SexALL
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Inclusion criteria
✓. Adult males or females aged 40 years or above;
✓. Diagnosed with idiopathic Parkinson's disease according to the UK Brain Bank Criteria, with onset after 40 years of age;
✓. Previous or current dopaminergic replacement therapy (e.g., levodopa) with good response; (4) Hoehn and Yahr (H\&Y) stage 1.5-2.5;
✓. Ability to walk independently without assistive devices for at least 5 minutes;
✓. Absence of severe freezing of gait (FOG);
✓. Disease duration ≥2 years since diagnosis, with stable clinical condition and ability to comply with study assessments and interventions;
✓. Stable medication dosage for at least 4 weeks prior to the study;
✓. Hoehn and Yahr (H\&Y) stage 1.5-2.5;
Exclusion criteria
✕. Presence of other neurological disorders that may interfere with the study
What they're measuring
1
UPDRS-3
Timeframe: From enrollment through the 3-month follow-up
. Mild or greater cognitive impairment (MoCA score ≤23)
✕. Orthopedic or other health conditions that may affect gait or balance
✕. Contraindications to MRI scanning, such as claustrophobia
✕. History of antipsychotic, antidepressant, or other medications that may affect dopamine levels
✕. Other significant psychiatric history
✕. Contraindications including history of epilepsy, traumatic brain injury, or implanted metal devices in the brain or heart (e.g., stimulators, pacemakers)