The Efficacy and Safety of Temporal Interference Stimulation on Motor Symptoms of Parkinson's Disease
2026年8月8日 更新者:Panpan Hu, MD、The First Affiliated Hospital of Anhui Medical University
The Efficacy and Safety of Temporal Interference Stimulation on Motor Symptoms of Parkinson's Disease: A Three-arm, Randomized, Double-blind, Parallel-controlled Study
This study aimed to evaluate the clinical efficacy and safety of temporal interference stimulation (TIS) targeting different targets in patients with Parkinson's disease (PD), and to investigate the associated neurophysiological mechanisms.
A three-arm, randomised, double-blind, parallel-group design was employed, consisting of a right globus pallidus internus (GPi) stimulation group, a right subthalamic nucleus (STN) stimulation group, and a sham stimulation group.
PD patients in the OFF-medication state (≥12 hours after the last dopaminergic dose) were randomly assigned to receive either active TIS targeting the GPi or STN, or sham stimulation, with each session lasting 30 minutes.
Clinical symptom assessments were conducted before and immediately after the intervention, and safety was monitored throughout by the research team.
研究概览
研究类型
介入性
注册 (实际的)
96
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
Anhui
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Hefei、Anhui、中国
- The First Affiliated Hospital of Anhui Medical University
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Age >= 40 years;
- Meet the diagnostic criteria for primary Parkinson's disease (MDS Parkinson's Disease Diagnostic Criteria (2015 Edition));
- No medication adjustment in the 4 weeks before and during each stimulation;
- MDS-UPDRS III score >= 8 points, Hoehn-Yahr score 1-4 points
Exclusion Criteria:
- Focal brain injury or severe leukoencephalopathy (Fazekas grade 3 or above) on previous head MRI/CT scans;
- Various secondary Parkinson's syndromes (vascular Parkinson's syndrome, drug-induced Parkinson's syndrome, etc.);
- Severe craniocerebral trauma, cranial surgery or deep brain stimulation treatment;
- Ferromagnetic implants in the body, such as cochlear implants, cardiac pacemakers, etc.;
- A history of epilepsy, unexplained loss of consciousness, or taking anticonvulsant drugs for epileptic seizures;
- Diagnosed with neuropsychiatric diseases other than Parkinson's disease;
- A history of drug abuse or drug use;
- Participated in any clinical trial in the past 3 months;
- Pregnant/lactating women or subjects (including men) who plan to have children within 6 months;
- Other situations that the researchers consider unsuitable for inclusion.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
假比较器:假手术组
|
Temporal Interference Stimulation
|
|
实验性的:GPi group
|
Temporal Interference Stimulation
|
|
实验性的:STN group
|
Temporal Interference Stimulation
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
The part III of MDS-Unified Parkinson's Disease Rating Scale
大体时间:Baseline,Immediately after a single stimulation
|
Baseline,Immediately after a single stimulation
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Hoehn-Yahr Stage Scale
大体时间:Baseline,Immediately after a single stimulation
|
Baseline,Immediately after a single stimulation
|
|
|
3-Meter Timed Up and Go Test
大体时间:Baseline,Immediately after a single stimulation
|
Baseline,Immediately after a single stimulation
|
|
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10-meter walking test
大体时间:Baseline,Immediately after a single stimulation
|
Baseline,Immediately after a single stimulation
|
|
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Upper and lower limb alternation
大体时间:Baseline,Immediately after a single stimulation
|
Baseline,Immediately after a single stimulation
|
|
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Clinical Global Impression
大体时间:Baseline,Immediately after a single stimulation
|
CGI comprehensively quantifies the severity of a patient's illness and the net benefit of treatment by assessing disease severity (CGI-S), overall improvement (CGI-I), and the balance between efficacy and side effects (Efficacy Index EI).
|
Baseline,Immediately after a single stimulation
|
|
Resting-state electroencephalogram(rsEEG)
大体时间:Baseline,Immediately after a single stimulation
|
Baseline,Immediately after a single stimulation
|
|
|
Transcranial Magnetic Stimulation-Electroencephalography(TMS-EEG)
大体时间:Baseline,Immediately after a single stimulation
|
Transcranial magnetic stimulation (TMS) combined with electroencephalography (EEG) is a technique used to assess cortical excitability and causal network connectivity.
|
Baseline,Immediately after a single stimulation
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年5月6日
初级完成 (实际的)
2026年7月16日
研究完成 (实际的)
2026年8月1日
研究注册日期
首次提交
2026年4月27日
首先提交符合 QC 标准的
2026年5月3日
首次发布 (实际的)
2026年5月7日
研究记录更新
最后更新发布 (实际的)
2026年8月11日
上次提交的符合 QC 标准的更新
2026年8月8日
最后验证
2026年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.