A Randomized, Double-blind, Multicenter, Placebo-controlled Trial (PRESS-PD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 290
- 试验地点
- 1
- 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
This is a multi-center, double-blind, randomized controlled study that will be implemented in multiple hospital centers in China. In this study, the supplementary motor area (SMA) of the dominant hemisphere was selected as the stimulation target, and continuous theta burst stimulation (cTBS) sequence contact stimulation was used for a course of continuous stimulation for 7 days to observe the changes in clinical symptoms before and after the intervention.
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
- Double (Participant, Investigator)
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 the diagnostic criteria for idiopathic Parkinson's disease (MDS Diagnostic Criteria for Parkinson's Disease (2015 Edition))[1];
- •Have no history of drug adjustment within 4 weeks before treatment and the entire study period;
- •The MDS-UPDRS Ⅲ score ≥8, and the Hoehn-Yahr rating is 1-4;
- •MMSE ≥22，able to cooperate with the completion of behavioral tests and transcranial magnetic stimulation therapy.
排除标准
- •Previously head MRI/CT was focal brain injury or severe leukoencephalopathy (Fazekas grade 3 and above);
- •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 has 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
- 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)
- 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)
- Hoehn-Yahr(H-Y) scale(baseline; day 8; week 5;week 9)
- Hamilton Anxiety Scale（HAMA）(baseline; day 8; week 5;week 9)
- 20 meters walking(baseline; day 8; week 5;week 9)
- Clinical Global Impression（CGI）(baseline; day 8; week 5;week 9)
- Non-motor symptom scale（NMSS）(baseline; day 8; week 5;week 9)
- Parkinson's Disease questionnaire-39 items（PDQ-39）(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)
- Mini-Mental State Examination（MMSE）(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