Clinical Trial

The Efficacy and Safety of Temporal Interference Stimulation on Motor Symptoms of Parkinson's Disease

Completed
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Summary
This study aimed to evaluate the clinical efficacy and safety of temporal interference stimulation (TIS) targeting different targets in patients with Parkinson's disease (PD), and to investigate the associated neurophysiological mechanisms. A three-arm, randomised, double-blind, parallel-group design was employed, consisting of a right globus pallidus internus (GPi) stimulation group, a right subthalamic nucleus (STN) stimulation group, and a sham stimulation group. PD patients in the OFF-medication state (≥12 hours after the last dopaminergic dose) were randomly assigned to receive either active TIS targeting the GPi or STN, or sham stimulation, with each session lasting 30 minutes. Clinical symptom assessments were conducted before and immediately after the intervention, and safety was monitored throughout by the research team.
Protocol Amendment History 2 changes
critical Trial completed 2026-08-12
critical Recruitment opened 2026-05-13
Trial Details
NCT Number NCT07572903
Lead Sponsor The First Affiliated Hospital of Anhui Medical University
Conditions Parkinson s Disease
Enrollment 96 participants
Start Date 2026-05-06
Primary Completion 2026-07-16 (estimated)
Study Completion 2026-08-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-11