Safety and Efficacy of Non Invasive Transcranial Brain Stimulation in Motor Stroke Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Change from the baseline ARAT (measures Grasp, Grip, Pinch, Gross Movement)
研究概览
简要总结
Patients were randomized in 3 groups: two intervent groups and a control group. The first group received two weeks of daily session of repetitive Transcranial Magnetic Stimulation (rTMS, 10 sessions) and, at least 6 months after, two weeks of daily transcranial Direct Current Stimulation (tDCS, 10 sessions); the second group received 10 daily session of tDCS and, after at least 6 months, 10 sessions of rTMS; the control group received 10 daily session of sham tDCS.
Physiatric evaluations (ARAT scale), neuropsychological assessment and ERP (P300) were performed before (1 week) and after (1 week) the end of each treatment. Furthermore, all patients underwent follow-up neuropsychological assessment 6 months after the end of each stimulation period and follow-up physiatric evaluation at 3 and 6 months after the end of each stimulation period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ischemic or hemorrhagic stroke (> 6 months from the accident)
排除标准
- •general cognitive impairment (Mini Mental State Examination < 25), severe functional disability (Barthel Index < 45),
- •psychiatric disorders,
- •degenerative neurological disorders,
- •epilepsy,
- •severe medical conditions,
- •having been implanted a drug infusion system, spinal/brain-stimulator, or endovascular coil
研究组 & 干预措施
tDCS+rTMS
Stroke patients were treated with an initial two weeks of transcranial direct current stimulation and after six months with two weeks of repetitive transcranial magnetic stimulation.
干预措施: tDCS (Device)
tDCS+rTMS
Stroke patients were treated with an initial two weeks of transcranial direct current stimulation and after six months with two weeks of repetitive transcranial magnetic stimulation.
干预措施: rTMS (Device)
rTMS+tDCS
Stroke patients were treated with an initial two weeks of repetitive transcranial magnetic stimulation and after six months with two weeks of transcranial direct current stimulation.
干预措施: tDCS (Device)
rTMS+tDCS
Stroke patients were treated with an initial two weeks of repetitive transcranial magnetic stimulation and after six months with two weeks of transcranial direct current stimulation.
干预措施: rTMS (Device)
Sham stimulation
Stroke patients were treated with two weeks of sham transcranial direct current stimulation.
干预措施: Sham (Device)
结局指标
主要结局
Change from the baseline ARAT (measures Grasp, Grip, Pinch, Gross Movement)
时间窗: Baseline; 1 month; 3 months; 6 months; 6 months and 1 week; 7 months; 9 months; 12 months
Action Research Arm Test (ARAT) measures Grasp, Grip, Pinch, Gross Movement. Baseline is 1 week before first treatment; other time frame: 1 week after first treatment; 3 months after first treatment; 6 months follow-up after first treatment; 1 week before second treatment; 1 week after second treatment; 3 months follow-up after second treatment; 6 months follow-up after second treatment.
次要结局
- P300 (latency)(Baseline; 1 month; 6 months and 1 week; 7 months)
- Cognition (standardized neuropsychological assessment)(Baseline; 1 month; 6 months; 6 months and 1 week; 7 months; 12 months)
研究者
Federico Dagata
Assistant Professor
University of Turin, Italy