Effects of Repetitive Transcranial Magnetic Stimulation and Transcranial DC Stimulation on Motor Function in Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Changes in cortical excitability measures
研究概览
简要总结
In this study the investigators aim to investigate the effects of two different types of non-invasive brain stimulation techniques -- repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS) on motor function in stroke. This is a cross-over study where subjects will receive 5 sessions of stimulation (each separated by 1 week) -- with either active tDCS and sham rTMS, sham tDCS and active rTMS or both sham tDCS and rTMS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(1) All subjects must be between the ages of 18-90.
排除标准
- •History of Major depression, as defined by Beck Depression scale 30;
- •Any substantial decrease in alertness, language comprehension, or attention that might interfere with understanding instructions for motor testing;
- •Contraindications to TMS
- •history of seizures
- •unexplained loss of consciousness
- •metal in the head
- •frequent or severe headaches or neck pain
- •implanted brain medical devices.
- •Contraindications to tDCS
- •metal in the head
- •implanted brain medical devices
- •Advanced liver, kidney, cardiac, or pulmonary disease;
- •A terminal medical diagnosis consistent with survival < 1 year;
- •Coexistent major neurological or psychiatric disease (to decrease number of confounders);
- •A history of significant alcohol or drug abuse in the prior 6 months;
- •Subjects may not be actively enrolled in a separate intervention study targeting stroke recovery and any other clinical trials;
- •Subjects with global aphasia and deficits of comprehension
- •Pregnancy. Female subjects of child bearing potential will be asked to take a pregnancy test. If the pregnancy test is positive, the subject may not enroll in the study.
- •Use of neuropsychotropic medications [healthy subjects only]
- •Additional inclusion criteria for stroke subjects:
- •First-time clinical ischemic or hemorrhagic cerebrovascular events - evidenced by a radiological (or physician's) report
- •Weakness, defined as score of less than 55 (out of 66) on arm motor Fugl-Meyer (FM) scale
- •Stroke onset >6 months prior to study enrollment .
- •Additional exclusion criteria for stroke subjects:
- •Subjects may not have already received TMS and/or tDCS stimulation for stroke;
- •History of epilepsy before stroke or episodes of seizures within the last six months;
结局指标
主要结局
Changes in cortical excitability measures
时间窗: Measured for approximately 6 weeks
We will measure cortical excitability using single- and paired-pulse transcranial magnetic stimulation (TMS) before and after each stimulation session. We will compare the measurements from before stimulation to after stimulation, in each scheduled session, as this study is measuring the effects of a single session of tDCS/rTMS.
次要结局
- Changes in motor function(Measured for approximately 6 weeks)
研究者
Felipe Fregni
Associate Professor
Spaulding Rehabilitation Hospital