Intrapatient Comparison of STN and GPi tTIS in PD

Shanghai Jiao Tong University

Status: Invitation-only

Conditions: Parkinson Disease

Treatments: Device: NervioX-2400

Study type: Interventional

Funder types: Other

Identifiers

NCT07018388

2025140B

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 55 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 2 patient groups

STN-tTIS

Experimental group

Description:

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.

Treatment:

Device: NervioX-2400

Device: NervioX-2400

GPi-tTIS

Experimental group

Description:

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.

Treatment:

Device: NervioX-2400

Device: NervioX-2400