Intrapatient Comparison of STN and GPi tTIS in PD

Официальное название

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

Обзор

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?

Подробное описание

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.

Вмешательства

• Устройство 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.
• Устройство 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.
• Устройство 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.

Первичные конечные точки

• MDS-UPDRS-Ⅲ scores [Срок оценки: pre-intervention, immediately after the intervention]

Вторичные конечные точки (1)

• MDS-UPDRS-Ⅲ sub-scores [Срок оценки: pre-intervention, immediately after the intervention]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Ruijin Hospital — Шанхай

Идентификаторы

NCT: NCT07018388 · 2025140B

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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