Temporal Interference Noninvasive Deep Brain Stimulation for Idiopathic Parkinson's Disease and Parkinsonian Syndromes: Effects and Target Exploration

Condition(s) studied

Investigational drug(s) / intervention(s)

AB Temporal Interference Stimulation: Participants with PD or PDS receive TIS. Each session lasts 30 minutes for 3 consecutive days. The study uses a crossover design with AB sequence (Active → Sham). Active stimulation: current 1.5-4 mA (patient's maximum tolerated), carrier frequency 2000 Hz, frequency offset 130 Hz; Sham stimulation: current 1.5-4 mA, carrier frequency 2000 Hz, frequency offset 0 Hz.

BA Temporal Interference Stimulation: Participants with PD or PDS receive TIS. Each session lasts 30 minutes for 3 consecutive days. The study uses a crossover design with BA sequence (Sham → Active). Sham stimulation: current 1.5-4 mA, carrier frequency 2000 Hz, frequency offset 0 Hz. Active stimulation: current 1.5-4 mA (patient's maximum tolerated), carrier frequency 2000 Hz, frequency offset 130 Hz;

Study summary

This study aims to explore the therapeutic effects of noninvasive deep brain electrical stimulation using temporal interference principles (Temporal Interference Stimulation, TIS) on both motor and non-motor symptoms in patients with idiopathic Parkinson's disease and Parkinsonian syndromes, and to investigate strategies for optimal stimulation target selection. A prospective, single-center, double-blind, randomized, crossover design will be implemented. Participants will be recruited from outpatient and inpatient departments of Ruijin Hospital, Shanghai Jiao Tong University School of Medicine. The primary hypothesis is that TIS will significantly improve motor symptoms in patients with Parkinson's disease and Parkinsonian syndromes. The primary outcome measure will be the change in the MDS-UPDRS Part III score from baseline to post-stimulation.

This study is expected to provide direct evidence supporting the clinical application and target selection strategies of noninvasive deep brain stimulation for the treatment of Parkinson's disease and Parkinsonian syndromes.

Eligibility

Primary outcome measure(s)

• Efficacy of temporal interference stimulation (TIS) on motor symptoms in patients with idiopathic Parkinson's disease and Parkinsonian syndromes — Baseline, 3 days after sham stimulation, and 3 days after active stimulation.
  The MDS-UPDRS Part III is a rater-administered motor examination used to evaluate the severity of motor impairment in patients with idiopathic Parkinson's disease and Parkinsonian syndromes. The total score ranges from 0 to 132, with lower scores indicating less severe motor symptoms. Changes from baseline after real or sham stimulation will be analyzed and compared between groups.

Trial sites (1)

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