Effect of Combined Anodal tDCS and Peripheral Nerve Stimulation on Motor Recovery in Acute Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Jebsen Taylor test
研究概览
简要总结
Recent work showed that application of peripheral nerve and cortical stimulation independently can induce 10-15 % improvement in motor performance in patients with chronic stroke.
The purpose of this study was to compare in post-stroke hemiplegic patients the effect on motor recovery of one session of anodal transcranial direct current stimulation to the ipsilesional primary motor cortex (M1) combined with a peripheral radial nerve electrical stimulation (rEPNS) to the paretic hand repeated 5 successive days with the effect of the same peripheral nerve stimulation combined with sham tDCS.
Design: randomized, double-blind, parallel controlled clinical trial. Patients eligible for the study: Acute ischaemic stroke Primary outcome measure: Jebsen Taylor test Secondary outcome measures Nine peg hole test Hand tapping grip and wrist force Cortical excitability of Ipsilesional M1(TMS) Follow-up: 30 days
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
- 35 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- first -ever ischemic stroke within 5-30 days a paresis of the arm/hand with NIHSS <15 age 35-85 years
排除标准
- •Pregnancy psychiatric disease patients with history of alcohol or drug abuse or severe depression patients with a severe language disturbances, particularly of receptive nature patients with increased intracranial pressure or serious cardiac disease patients with contraindication to TMS
研究组 & 干预措施
tDCS + rEPNS
Patients with hemiplegia due to a stroke : application of 5 consecutive sessions of true anodal tDCS applied to the primary motor cortex on the affected side, combined with repetitive peripheral electrical stimulation
干预措施: combined transcranial direct current stimulation and electrical peripheral nerve stimulation (Device)
结局指标
主要结局
Jebsen Taylor test
时间窗: 5-15-30 days
次要结局
- Grip and wrist force Nine peg hole Cortical excitability ofIpsilesional M1 (TMS)(5-15-30 days)