Intrapatient Comparison of STN and GPi tTIS in PD (NCT07018388) — China Trial Details

Condition(s) studied

Parkinson Disease

Investigational drug(s) / intervention(s)

NervioX-2400NervioX-2400NervioX-2400

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.

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.

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.

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?

Eligibility

Sex

ALL

Min age

50 Years

Max age

85 Years

Healthy volunteers

No

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.

Primary outcome measure(s)

MDS-UPDRS-Ⅲ scores — 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.

Trial sites (1)

Facility	City	Region	Status
Ruijin Hospital	Shanghai	Shanghai Municipality

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