NCT07018388

Intrapatient Comparison of STN and GPi tTIS in PD

Intrapatient Comparison of Subthalamic and Globus Pallidus Internus Temporal Interference Stimulation in Parkinson's Disease

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to investigate the therapeutic efficacy of tTIS in patients with Parkinson's disease and to evaluate the immediate effects and conduct intrapatient comparisons of individualized 130 Hz Subthalamic Nucleus-transcranial Temporal Interference Stimulation (STN-tTIS) and Globus Pallidus Internus-transcranial Temporal Interference Stimulation (GPi-tTIS) on motor symptoms in patients with early to mid-stage Parkinson's Disease (PD) during "off" medication states. The main questions this study aims to answer are: 1. Can tTIS significantly improve the motor symptoms of patients with Parkinson's disease? 2. Is the therapeutic effect of STN-tTIS superior to that of GPi-tTIS?

Detailed description

This clinical trial aims to verify the efficacy of tTIS in patients with Parkinson's disease and to explore which targets are better for improving PD motor symptoms.Patients were randomly assigned to receive Stimulation Type A, B, or C. Type A received STN-tTIS therapy; Type B received GPi-tTIS therapy; Type C received sham stimulation targeting the subthalamic nucleus. Each session lasted 20 minutes, and patients were in the off-medication state for all treatments.The order of stimulation types was randomized, with at least 7 days of washout between sessions to avoid carryover effects. MDS-UPDRS-III evaluations were assessed before and after each treatment.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DEVICE	NervioX-2400	To design the individualized STN-tTIS, each patient completes a T1-weighted anatomical magnetic resonance imaging (MRI) scan. The individual's structural brain MRI data are used to determine the STN-tTIS montage and stimulation settings through computational modeling.
DEVICE	NervioX-2400	To design the individualized GPi-tTIS, each patient completes a T1-weighted anatomical magnetic resonance imaging (MRI) scan. The individual's structural brain MRI data is used to determine the GPi-tTIS montage and stimulation settings via computational modeling.
DEVICE	NervioX-2400	To design the individualized STN-tTIS, each patient completes a T1-weighted anatomical magnetic resonance imaging (MRI) scan. The individual's structural brain MRI data are used to determine the STN-tTIS montage and stimulation settings through computational modeling.

Timeline

• Start date: 2025-04-23
• Primary completion: 2026-02-28
• Completion: 2026-03-15
• First posted: 2025-06-12
• Last updated: 2026-02-27

Locations

1 site across 1 country: China