The Efficacy and Safety of Temporal Interference Stimulation on Motor Symptoms of Parkinson's Disease: A Three-arm, Randomized, Double-blind, Parallel-controlled Study
This study aimed to observe the clinical efficacy and safety of single-target transcranial temporal stimulation (tTIS) intervention in Parkinson's disease (PD) patients and explore the neurophysiological mechanism of TIS intervention. The study was designed as a three-arm (A: GPi group, B: STN group, C: Sham group), randomized, double-blind, parallel-controlled trial. PD patients in the drug-off state (≥12 hours after drug withdrawal) were randomly assigned to receive either tTIS or sham stimulation targeting GPi/STN, with each stimulation lasting 30 minutes. Clinical symptom assessments were conducted before and after the intervention, and safety was monitored by researchers throughout the process.
• Age \>= 40 years;
• Meet the diagnostic criteria for primary Parkinson's disease (MDS Parkinson's Disease Diagnostic Criteria (2015 Edition));
• No medication adjustment in the 4 weeks before and during each stimulation;
• MDS-UPDRS III score \>= 8 points, Hoehn-Yahr score 1-4 points