Intrapatient Comparison of Subthalamic and Globus Pallidus Internus Temporal Interference Stimulation in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- MDS-UPDRS-Ⅲ scores
研究概览
简要总结
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:
- Can tTIS significantly improve the motor symptoms of patients with Parkinson's disease?
- Is the therapeutic effect of STN-tTIS superior to that of GPi-tTIS?
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
STN-tTIS
Patients in this group receive 20 minutes of individualized 130 Hz STN-tTIS sessions targeting the more affected hemisphere during medication "off" and are evaluated for the MDS-UPDRS-Ⅲ before and after treatment.
干预措施: NervioX-2400 (Device)
GPi-tTIS
Patients in this group receive 20 minutes of individualized 130 Hz GPi-tTIS sessions targeting the more affected hemisphere during medication "off" and are evaluated for the MDS-UPDRS-Ⅲ both before and after treatment.
干预措施: NervioX-2400 (Device)
Sham stimulation
Patients in this group receive sham stimulation targeting the subthalamic nucleus in the more affected hemisphere during the medication "off" state, with a stimulation beat frequency of 0 Hz. Each session lasts 20 minutes, and the MDS-UPDRS-III is assessed both before and after treatment.
干预措施: NervioX-2400 (Device)
结局指标
主要结局
MDS-UPDRS-Ⅲ scores
时间窗: 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.
次要结局
- MDS-UPDRS-Ⅲ sub-scores(pre-intervention, immediately after the intervention)