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Enrolling by Invitation

NCT Number: NCT07018388

Intrapatient Comparison of STN and GPi tTIS in PD

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?

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Key information

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ruijin Hospital

Shanghai, Shanghai Municipality, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NervioX-2400

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.

Primary outcomes

  1. MDS-UPDRS-Ⅲ scores

    Time frame: 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.

Secondary outcomes

  1. MDS-UPDRS-Ⅲ sub-scores

    Time frame: pre-intervention, immediately after the intervention

    The MDS-UPDRS-III assesses motor symptoms in Parkinson's disease through sub-scores: Tremor Sub-score: Items 15-18; range 0-16. Higher scores indicate more severe tremors. Rigidity Sub-score: Item 3; range 0-12. Higher scores reflect greater rigidity. Bradykinesia Sub-score: Items 2, 4-9, and 14; range 0-40. Higher scores indicate more severe slowness of movement. Axial Sub-score: Items 1 and 9-13; range 0-24. Higher scores suggest more significant axial impairments.

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 12, 2025
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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