The Efficacy of Repetitive Transcranial Magnetic Stimulation in Parkinson's Disease：A Randomized, Double-blind, Multicenter, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 312
- 主要终点
- Movement Disorder Society- Unified Parkinson's Disease Rating Scale III scores
研究概览
简要总结
Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive and widely used neuromodulation technology. Small sample studies have shown that rTMS treatment can significantly improve the symptoms of Parkinson's disease(PD) and delay the progression of the disease. In order to further explore the effectiveness of rTMS in the treatment of PD and lay the foundation for its clinical promotion, our research team plans to conduct a randomized double-blind controlled study of rTMS in the treatment of PD in multiple centers across the country.
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 randomized, controlled, double-blind, placebo-treated, multicenter study designed to recruit 312 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. The study is expected to be conducted across nine medical centers in China, commencing in 2024 and concluding in 2026.
This study will evaluate the clinical efficacy of cTBS targeting the left SMA in patients with Parkinson's disease. The findings may offer a new therapeutic approach for PD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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.
结局指标
主要结局
Movement Disorder Society- Unified Parkinson's Disease Rating Scale III scores
时间窗: baseline; day 8; week 5;week 9
This is an very common clinical motor estimating scale with 18 items and 140' in total. Higher scores indicate worse symptoms.
次要结局
- Hamilton Anxiety Scale（HAMA）(baseline; day 8; week 5;week 9)
- Movement Disorder Society- Unified Parkinson's Disease Rating Scale I scores(baseline; day 8; week 5;week 9)
- Movement Disorder Society- Unified Parkinson's Disease Rating Scale Ⅱ scores(baseline; day 8; week 5;week 9)
- Hoehn-Yahr(H-Y) scale(baseline; day 8; week 5;week 9)
- The timed up and go test (TUG)(baseline; day 8; week 5;week 9)
- Movement Disorder Society- Unified Parkinson's Disease Rating Scale Ⅳ scores(baseline; day 8; week 5;week 9)
- 20 meters walking(baseline; day 8; week 5;week 9)
- Upper and lower limb rotation counting(baseline; day 8; week 5;week 9)
- Parkinson's Disease questionnaire-39 items（PDQ-39）(baseline; day 8; week 5;week 9)
- Non-motor symptom scale（NMSS）(baseline; day 8; week 5;week 9)
- Clinical Global Impression（CGI）(baseline; day 8; week 5;week 9)
- Hamilton Depression Scale-17（HAMD-17）(baseline; day 8; week 5;week 9)
- Pittsburgh sleep quality index（PSQI）(baseline; day 8; week 5;week 9)
- Montreal Cognitive Assessment（MoCA）(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