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Intrapatient Comparison of STN and GPi tTIS in PD

Enrolling By InvitationNA

Sponsor: Ruijin Hospital

Conditions: Parkinson Disease

Interventions: NervioX-2400, NervioX-2400, NervioX-2400

Countries: China

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?

Eligibility overview

Sex: ALL

Age: 50 Years to 85 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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);
* 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.

Locations (1)

Shanghai, Shanghai Municipality, China