Intrapatient Comparison of STN and GPi tTIS in PD

NCT ID: NCT07018388

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-23
• Study Completion Date: 2025-06-30

Brief Summary

The goal of this clinical trial is 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 "on" medication states.

The main questions this study aims to answer are:

1. Is the therapeutic effect of STN-tTIS superior to that of GPi-tTIS?

2. What is the degree of improvement in motor symptoms of Parkinson's Disease patients after receiving STN-tTIS or GPi-tTIS during the "on" medication phase?

Researchers will compare the MDS-UPDRS-III improvement scores of tTIS therapy at different targets. Participants are required to:

1. Visit the clinic twice within two weeks for therapy and testing.

2. Record their symptoms and scores.

Detailed Description

This clinical trial aims to explore which targets are better for improving PD motor symptoms. Patients were randomly assigned to either Group A or Group B. Group A first received STN-tTIS therapy, followed by GPi-tTIS therapy; Group B received the treatments in the reverse order. Each session lasted 20 minutes, and patients were in the on-medication state for both treatments. The order of sessions 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

STN-tTIS

Patients in this group receive 20 minutes of individualized 130 Hz STN-tTIS sessions targeting the more affected hemisphere's STN during medication "on" and are evaluated for the MDS-UPDRS-Ⅲ before and after treatment.

Group Type: EXPERIMENTAL

NervioX-2400

Intervention Type: DEVICE

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.

GPi-tTIS

Patients in this group receive 20 minutes of individualized 130 Hz GPi-tTIS sessions targeting the more affected hemisphere's STN during medication "on" and are evaluated for the MDS-UPDRS-Ⅲ both before and after treatment.

Group Type: EXPERIMENTAL

NervioX-2400

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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);
• History of 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.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ruijin Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

2025140B

Identifier Type: -

Identifier Source: org_study_id