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

Sponsor
Ruijin Hospital
Study ID
NCT07698236
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • AB Temporal Interference Stimulation — DEVICE
    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 — DEVICE
    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 Details

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.

Key Dates

First listed
Jul 13, 2026
Start date
Jul 3, 2026
Status verified
Jul 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: GPi TIS
    Participants with PD or PDS receive TIS targeting the contralateral globus pallidus internus (GPi). Each group consists of 10 patients with PD and 10 patients with PDS.
  • Experimental: STN TIS
    Participants with PD or PDS receive TIS targeting the contralateral subthalamic nucleus (STN). Each group consists of 10 patients with PD and 10 patients with Parkinsonian syndromes.
  • Experimental: Putamen TIS
    Participants with PD or PDS receive TIS targeting the contralateral putamen. Each group consists of 10 patients with PD and 10 patients with Parkinsonian syndromes.
  • Experimental: LHA TIS
    Participants with PD or PDS receive TIS targeting the contralateral lateral hypothalamic area (LHA). Each group consists of 10 patients with PD and 10 patients with Parkinsonian syndromes.
  • Experimental: Dentate TIS
    Participants with PD or PDS receive TIS targeting the ipsilateral cerebellar dentate nucleus. Each group consists of 10 patients with PD and 10 patients with Parkinsonian syndromes.

Primary Outcome Measure

Efficacy of temporal interference stimulation (TIS) on motor symptoms in patients with idiopathic Parkinson's disease and Parkinsonian syndromes [ Time Frame: Baseline, 3 days after sham stimulation, and 3 days after active stimulation. ]

Find similar trials

Nationwide
Parkinson's disease trialsNeurology trialsBrain disorders trials

Related Studies