Effects of a Periodic Repetitive Transcranial Magenetic Stimulation in Parkinson Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Unified Parkinson's Disease Rating Scale III scores
研究概览
简要总结
Previous studies have shown that repetitive transcranial magnetic stimulation(rTMS) can improve clinical symptoms of Parkinson's disease(PD). Continuous theta-burst stimulation(cTBS) is a novel rTMS protocol that produces physiological effects b acting on neurons in the brain, which can decrease the excitability of motor system. This study aims to explore the long-term effects of cTBS on improvement of movement symptoms in patients with PD.
详细描述
This was a open-label clinical trial to assess the Effects of a Periodic Repetitive Transcranial Magenetic Stimulation in Parkinson Disease.
Participants were randomly assigned to the cTBS group and the control group on a 1:1 basis using age as a stratification factor. In the cTBS group, after baseline assessment, participants received cTBS treatment on the left supplementary motor area(SMA) for 14 days, and symptoms were assessed on the second day after treatment. Ten weeks after completion of assessment, a second cTBS session was performed, with all patients taking stable doses of antiparkinsonian medications. The control group only received drug intervention, and symptom assessment was conducted at weeks 13, 23 , 33 , and 43. To rule out the influence of medication on symptom assessment, all patients stopped taking medication for at least 12 hours before assessment.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the Chinese diagnostic criteria for Parkinson's disease (2016 version);
- •Age ≥ 40 years old;
- •Stable use of medication for at least 2 weeks;
- •MMSE score ≧ 24 points;
- •Those who can cooperate to complete the experiment; (6) Those who have not received rTMS treatment in the past.
排除标准
- •History or clinical symptoms of other serious mental illnesses (such as major depression, psychosis, or obsessive-compulsive disorder);
- •Severe organic brain defects on T1 or T2 images;
- •History or unknown epilepsy Cause of loss of consciousness;
- •Head injury, stroke or other neurological disease;
- •Immovable metal objects on or around the head;
- •History of drug abuse within the past 6 months.
研究组 & 干预措施
cTBS group
On the basis of drug treatment, a course of TBS treatment is performed every eight weeks.
干预措施: transcranial magnetic stimulation (Other)
Drug group
Take antiparkinsonian medications regularly, with follow-up every 8 weeks including medication guidance and symptom assessment
干预措施: Pharmacotherapy（antiparkinsonian drugs） (Drug)
结局指标
主要结局
Unified Parkinson's Disease Rating Scale III scores
时间窗: baseline; week 3; week 13;week 23;week 33
This is an very common clinical motor estimating scale with 14 items and 108' in total. Higher scores indicate worse symptoms.
次要结局
- Levodopa equivalent dose(baseline; week 3; week 13;week 23;week 33)
- Hoehn-Yahr(H-Y) stage(baseline; week 3; week 13;week 23;week 33)
研究者
WANG KAI
Head, Dept of Neurology & Medical Psychology, Director, Cognitive Neuropsychology Lab, PRC
Anhui Medical University