Comparing Different Transcranial Direct Current Stimulation Montages in Acute Stroke Patients: a Randomized, Triple-blinded, Sham-controlled Study
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in Wolf Motor Function Test
研究概览
简要总结
40 acute subjects will be split into 5 groups. Each group will receive one of the following tDCS montages : anodal, bilateral, cathodal, extracephalic or placebo.
Subjects will receive, in addition to conventional rehabilitation, 2mA for 20 mins of their attributed tDCS, 5 times a week.
Evaluations will take place before the first stimulation period (48h post stroke), after 1, 2, 3 and 4 weeks. Evaluations consist of the Wolf Motor Function Test, the Fugl Meyer, and the Semmes Weinstein Monofilament Test
详细描述
40 acute subjects will be randomized and split into 5 groups.
Each group will receive one of the following tDCS montages :
Anodal : Anode placer over the affected primary motor cortex, cathode over contralateral supra orbital area Bilateral : Anode placer over the affected primary motor cortex, cathode over unaffected motor cortex Cathodal : Cathode placer over the unaffected primary motor cortex, anode over contralateral supra orbital area Extracephalic : Anode placer over the affected primary motor cortex, cathode over right shoulder Placebo : anode montage but current is ramped up over 15 secondes, then ramped down.
Subjects will receive, in addition to conventional rehabilitation (±1.5h/weekday), 2mA for 20 mins of their attributed tDCS, 5 times a week.
Evaluations will take place before the first stimulation period (48h post stroke), after 1, 2, 3 and 4 weeks. Evaluations consist of the Wolf Motor Function Test, the Fugl Meyer, and the Semmes Weinstein Monofilament Test
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Everyone is blinded, codes are selected by a third party not involved in any step of the study
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
- •First Ever Stroke
- •Motor or sensory deficit
- •Understands and follows orders
- •Signed inform consent
排除标准
- •One Yes on the medium and high risk sections of the TSST (Bornheim et al.,2019)
结局指标
主要结局
Change in Wolf Motor Function Test
时间窗: Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4
Functional upper limb test, filmed and scored subjectively
Change in Fugl Meyer Motor Assessment
时间窗: Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4
Functional upper limb, lower limb and sensory test
Change in Semmes Weinstein Monofilament Test
时间窗: Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4
11 Point Sensory test
次要结局
未报告次要终点
研究者
Bornheim Stephen
Assistant Professor
University of Liege