the Effects of Repetitive Transcranial Magnetic Stimulation and Mechanisms in Clinical Function of Essential Tremor
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The efficacy of the treatment on the essential tremor evaluated by Essential Tremor Rating Assessment Scale (TETRAS) score
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and electrophysiology of repetitive transcranial magnetic stimulation in the treatment of essential tremor.
详细描述
This is a randomized controlled study.The purpose is to evaluate the efficacy of repetitive transcranial magnetic stimulation(rTMS) in the treatment of essential tremor,and explore the possible mechanism by detecting the changes of clinical scale and TMS-electroencephalogram(TMS-EEG), so as to seek an effective therapy for essential tremor.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed as essential tremor conforming to the diagnostic criteria for essential tremor in the tremor group of the International Parkinson's and Movement Disorders Society (IPMDS).
- •Signed informed consent form.
排除标准
- •Complicated with brain organic diseases, epilepsy, other mental diseases, family history of dementia, metal devices implanted in the body and any contraindications to TMS;
- •History of craniocerebral surgery;
- •TMS cannot cooperate;
- •TMS-EEG examination artifacts are obvious, or cannot be analyzed due to other technical reasons.
结局指标
主要结局
The efficacy of the treatment on the essential tremor evaluated by Essential Tremor Rating Assessment Scale (TETRAS) score
时间窗: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)
The TETRAS is widely used tremor evaluation scale.TETRAS has been used for evaluation tremor in patients with essential tremor focuses primarily on the assessment of activities of daily living and tremor.The TETRAS score ranges from 0 to 112. The higher the TETRAS score, the more severe the symptoms.
Changes from baseline in tremor analysis
时间窗: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)
This outcome reflects quantitative changes in the patient's tremor.
次要结局
- Changes from baseline in TMS-EEG(visit 1(baseline), visit 2(Day 10), visit 3(Day 30))
- Change in Non-Motor Symptoms Rating Scale (NMSS) score from baseline(visit 1(baseline), visit 2(Day 10), visit 3(Day 30))
- Change in Montreal Cognitive Assessment (MOCA) score from baseline(visit 1(baseline), visit 2(Day 10), visit 3(Day 30))
- Changes from baseline in Hamilton Depression Scale-24(HAMD-24) score(visit 1(baseline), visit 2(Day 10), visit 3(Day 30))
- Change in Mini-Mental State Examination (MMSE) score from baseline(visit 1(baseline), visit 2(Day 10), visit 3(Day 30))
- Quality of Life Questionnaire (QUEST) score change from baseline(visit 1(baseline), visit 2(Day 10), visit 3(Day 30))
- RBD Screening Questionnaire (RBDSQ) score(visit 1(baseline))
- Changes from baseline in Hamilton Anxiety Scale(HAMA) score(visit 1(baseline), visit 2(Day 10), visit 3(Day 30))
- Change in Pittsburgh Sleep Quality Index (PSQI) score from baseline(visit 1(baseline), visit 2(Day 10), visit 3(Day 30))
- Test the sleep characteristics by polysomnography (PSG)(visit 1(baseline))
- Change in Fatigue Severity Scale (FSS) score from baseline(visit 1(baseline), visit 2(Day 10), visit 3(Day 30))
- test the characteristics of vestibular evoked myogenic potential (VEMP)(visit 1(baseline))
- test the gene's type of the notch2nlc(visit 1(baseline))
研究者
Chun-Feng Liu
Professor
Second Affiliated Hospital of Soochow University