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Enrolling by invitation NCT07018388

Intrapatient Comparison of STN and GPi tTIS in PD

No phase Interventional Parkinson Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: NervioX-2400, NervioX-2400, NervioX-2400.
Who it may be relevant to
Registry conditions: Parkinson Disease. Basic parameters: 50 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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?

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • MDS-UPDRS-Ⅲ scores [Time frame: pre-intervention, immediately after the intervention]
Secondary outcome measures (1)
  • MDS-UPDRS-Ⅲ sub-scores [Time frame: pre-intervention, immediately after the intervention]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Triple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Ruijin Hospital — Shanghai

Identifiers

NCT: NCT07018388 · 2025140B

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗