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Intrapatient Comparison of STN and GPi tTIS in PD

NCT07018388 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-04-22

No results posted yet for this study

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?

Conditions

  • Parkinson Disease

Interventions

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.

Sponsors & Collaborators

  • Ruijin Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-23
Primary Completion
2026-11-01
Completion
2026-11-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07018388 on ClinicalTrials.gov