Intrapatient Comparison of STN and GPi tTIS in PD

April 20, 2026 updated by: Ruijin Hospital

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

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?

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, China
        • Ruijin Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of primary Parkinson's disease (MDS);
  • Hoehn & Yahr stage ≤ 3;
  • Antiparkinsonian drugs must have remained unchanged in the past four weeks, and the dosage must have remained stable throughout the study.

Exclusion Criteria:

  • Presence of neurological disorders that may affect the study (e.g., traumatic brain injury);
  • Antipsychotics, antidepressants, or dopamine modulators outside of PD drugs;
  • Metal devices in the head or heart (e.g., deep brain stimulators, pacemakers);
  • Unstable vital signs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: STN-tTIS
Patients in this group receive 20 minutes of individualized 130 Hz STN-tTIS sessions targeting the more affected hemisphere during medication "off" and are evaluated for the MDS-UPDRS-Ⅲ before and after treatment.
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.
Experimental: GPi-tTIS
Patients in this group receive 20 minutes of individualized 130 Hz GPi-tTIS sessions targeting the more affected hemisphere during medication "off" and are evaluated for the MDS-UPDRS-Ⅲ both before and after treatment.
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.
Experimental: Sham stimulation
Patients in this group receive sham stimulation targeting the subthalamic nucleus in the more affected hemisphere during the medication "off" state, with a stimulation beat frequency of 0 Hz. Each session lasts 20 minutes, and the MDS-UPDRS-III is assessed both before and after treatment.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MDS-UPDRS-Ⅲ scores
Time Frame: pre-intervention, immediately after the intervention
The score range for MDS-UPDRS-III is from 0 to 132. The minimum value is 0, indicating no motor impairment, and the maximum value is 132, indicating the most severe motor impairment. Higher scores on the MDS-UPDRS-III indicate worse outcomes, as they reflect greater severity of motor symptoms.
pre-intervention, immediately after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MDS-UPDRS-Ⅲ sub-scores
Time Frame: pre-intervention, immediately after the intervention
The MDS-UPDRS-III assesses motor symptoms in Parkinson's disease through sub-scores: Tremor Sub-score: Items 15-18; range 0-16. Higher scores indicate more severe tremors. Rigidity Sub-score: Item 3; range 0-12. Higher scores reflect greater rigidity. Bradykinesia Sub-score: Items 2, 4-9, and 14; range 0-40. Higher scores indicate more severe slowness of movement. Axial Sub-score: Items 1 and 9-13; range 0-24. Higher scores suggest more significant axial impairments.
pre-intervention, immediately after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 23, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

June 5, 2025

First Submitted That Met QC Criteria

June 5, 2025

First Posted (Actual)

June 12, 2025

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 20, 2026

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025140B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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