An Open-label Study on the Clinical Efficacy of rTMS Intervention in PD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale Part Ⅲ
研究概览
简要总结
To demonstrate that intervention targeting the supplementary motor area (SMA) using precise navigation positioning can effectively improve motor symptoms in patients with Parkinson's disease.
详细描述
As an innovative non-invasive neuromodulation technology, repetitive transcranial magnetic stimulation (rTMS) has demonstrated efficacy in improving motor symptoms in patients with Parkinson's disease (PD). The supplementary motor area (SMA) has been identified as a brain region significantly associated with motor symptoms in PD patients. However, no large-sample clinical studies have yet established the clinical efficacy of rTMS, guided by neuroimaging navigation, targeting the SMA in patients with Parkinson's disease.
We describe a open-lable study designed to recruit 20 patients with idiopathic Parkinson's disease. Participants will be randomly assigned to receive either real stimulation or sham stimulation, with the left SMA undergoing 7 days of continuous theta burst stimulation (cTBS). The primary outcome measure is the change in the Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III scores from baseline to post-treatment and follow-up. Secondary outcomes include changes in scores on other clinical symptom scales.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥40 years old
- •Meet Movement Disorder Society standards;
- •Have no history of drug adjustment within 4 weeks before and during treatment;
- •The MDS-UPDRS Ⅲ score ≥8, and the Hoehn-Yahr rating is 1-4
- •MMSE ≥24，able to cooperate with the completion of behavioral tests and transcranial magnetic stimulation therapy.
排除标准
- •Head MRI/CT ruled out focal brain injury or severe leukoencephalopathy (Fazekas grade 3);
- •Various secondary parkinsonism syndromes (vascular parkinsonism, Parkinsonism combined with parkinsonism, drug parkinsonism, etc.);
- •Severe craniocerebral trauma, received craniocerebral surgery or deep brain stimulation treatment;
- •There are ferromagnetic implants in the body, such as cochlear implants, cardiac pacemakers, etc.
- •The person or first-degree relatives have a history of epilepsy, unexplained loss of consciousness, or are taking anticonvulsant drugs to treat epileptic seizures;
- •Diagnosed with a neuropsychiatric disorder other than PD
- •Have a history of drug abuse or drug use;
- •Participants in any clinical trial within the previous 6 month;
- •Pregnant/lactating women or subjects (including men) who have a birth plan within 6 months;
- •Other conditions deemed unsuitable for inclusion by the investigator.
研究组 & 干预措施
rTMS group
On the basis of drug treatment, a course of TBS treatment is performed for 7 days.
干预措施: transcranial magnetic stimulation (Other)
结局指标
主要结局
Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale Part Ⅲ
时间窗: baseline; day 8; week 5;week 9;
The primary outcome was the change in MDS-UPDRS III from baseline to 9 weeks of follow-up. MDS-UPDRS III is a questionnaire used by uniformly trained professionals to evaluate motor symptoms in patients with Parkinson's disease\[21\]. The questionnaire consists of 18 items, which professionals need to score according to the patient's motor symptoms, on a scale of 0-4. Among them, items 3.3-3.8 and 3.15-3.17 can be divided into several sub-items according to the body parts. The results of MDS-UPDRS III are the total of 18 items.
次要结局
- The timed up and go test(baseline; day 8; week 5;week 9;)
- Hoehn-Yahr(H-Y) stage(baseline; day 8; week 5;week 9;)
研究者
WANG KAI
Head, Dept of Neurology & Medical Psychology, Director, Cognitive Neuropsychology Lab, PRC
Anhui Medical University