Individualized 130 Hz Subthalamic Temporal Interference Stimulation Versus Medication for Motor Symptoms in Parkinson Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 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 evaluate the immediate effects of individualized 130 Hz STN-tTIS(Subthalamic Nucleus - transcranial Temporal Interference Stimulation)on motor symptoms in early-to-mid-stage PD patients during both medication "on" and "off" states. The main questions it aims to answer are:
- Does the therapeutic effect of STN - tTIS relate to medication?
- The degree of improvement in motor symptoms of Parkinson's disease patients after STN - tTIS therapy under different medication conditions.
Researchers compared the MDS - UPDRS - III improvement scores of tTIS therapy in the "on" and "off" medication phases to see if tTIS could work of independently medication.
- Visit the clinic once every 1 weeks for therapy and test.
- Record their symptoms and scores.
详细描述
This clinical trial aims to explore whether individualized 130 Hz subthalamic tTIS can improve motor symptoms of PD independently of medication. . Each participant underwent two separate 20-minute sessions of individualized 130 Hz STN-tTIS: one during medication "on" (defined as stable dopaminergic medication effect) and one during medication "off" (after ≥12 hours withdrawal of dopaminergic medications). The order of sessions was randomized with at least 7 days washout between sessions to avoid carryover effects. And MDS - UPDRS - III scales are 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
- Single (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
- •MDS diagnosis of primary Parkinson's disease
- •Hoehn & Yahr stage < 3
- •Antiparkinsonian drugs remained unchanged in the past four weeks and dosage remained unchanged during the study
排除标准
- •Presence of neurological disorders that may affect the study (e.g., Traumatic brain injury)
- •History of antipsychotics, antidepressants, or dopamine modulators other than 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
Only use STN - tTIS therapy.
Patients in this group received two 20-minute individualized 130 Hz STN-tTIS sessions targeting the more affected hemisphere's STN during medication "off" (≥12 hours withdrawal) and were evaluated for the MDS - UPDRS - III before and after treatment.
干预措施: NervioX-2400 (Device)
STN - tTIS therapy is used in combination with medication.
Patients in this group received two 20-minute individualized 130 Hz STN-tTIS sessions targeting the more affected hemisphere's STN during medication "on" and were evaluated for the MDS - UPDRS - III 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. Minimum Value: 0, indicating no motor impairment. Maximum Value: 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)