Functional Interest of Non Invasive Brain Stimulation During Physiotherapy at a Subacute Phase Post Stroke (Anodal Protocol).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Fugl Meyer Assessment (Upper extremity) of motor recovery following stroke
研究概览
简要总结
Previous research that utilises single sessions of transcranial direct current stimulation (tDCS) have demonstrated functional improvements. However these improvements are usually short-lived, lasting less than one hour before the patient's performance returns to baseline. In these studies, tDCS is typically applied with the goal of adaptively enhancing functional activation of pathologically under-active tissue or suppressing pathologically over-active tissue. Interestingly, a small body of evidence is now emerging to indicate that tDCS can improve learning/memory functions in healthy controls. The goal of this study is to test if the application of tDCS could enhance learning and/or memory for physiotherapy rehabilitation, which may in turn lead to correspondingly greater motor improvement. Patients at a subacute stage (1 to 6 month post stroke) will attend for 10 consecutive daily sessions of tDCS.
This research has important implications; previous studies suggest that such an approach has the potential to facilitate physical rehabilitation post-stroke and establish tDCS as a clinically viable rehabilitative tool. Recovery of motor skills may take many months to acquire and therefore strategies that have the potential to enhance acquisition of skill are of practical and scientific interest.
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
- •All subjects must be between the ages of 18-90 and must not be pregnant.
- •Patients volunteer to participate in the study, with a written informed consent signed
- •Affiliation to a national health insurance program
- •First-time clinical ischemic or hemorrhagic cerebrovascular accident - evidenced by a radiological (or physician's) report
- •Contralesional motor deficit
- •Lesion sparing primary motor cortex
- •Stroke onset >1 month and <6 months prior to study enrollment
排除标准
- •Coexistent major neurological or psychiatric disease as to decrease number of confounders
- •History of epilepsy before stroke (or episodes of seizures within the last six months)
- •Any substantial decrease in alertness, language reception, or attention that might interfere with understanding instructions for motor testing
- •Subjects with global aphasia and deficits of comprehension
- •Excessive pain in any joint of the paretic extremity (VAS>4)
- •Contraindications to Tdcs : metal in the head, implanted brain medical devices
- •Coexistent major neurological or psychiatric disease as to decrease number of confounders
- •A history of significant alcohol or drug abuse in the prior 6 months
- •Anyone who is currently taking or who has taken anti-malarial treatment in the last 72 hours
- •Subjects may not have already received constraint induced motor therapy and/or tDCS treatment for stroke
- •Pregnancy
研究组 & 干预措施
Sham tDCS and motor training: sham comparator
Participants will receive sham tDCS over the primary motor cortex of the ipsilesional hemisphere during 20 minutes of motor training (10 consecutive sessions Monday-Friday during two weeks).
Intervention: placebo tDCS Other: Motor Training
干预措施: Sham tDCS (Device)
Anodal tDCS and motor training: experimental
Participants will receive anodal tDCS over the primary motor cortex of the ipsilesional hemisphere. The following parameters will be used: stimulation intensity of 1mA during 20 minutes of motor training (10 consecutive sessions Monday-Friday during two weeks).
Interventions:
- Device: anodal tDCS
- Other: motor Training during physiotherapy
干预措施: anodal tDCS (device) Eldith DC-Stimulator (Device)
结局指标
主要结局
Fugl Meyer Assessment (Upper extremity) of motor recovery following stroke
时间窗: assessed at one baseline session (day 4), and then again immediately following the last day of the intervention (day 18), 2 weeks (day 32), 1 month, 3 months and 6 months later.
Main primary outcome is change in score between the baseline session score and day 32.
次要结局
- Jebsen Taylor Hand function test (JTT)(assessed at one baseline session (day 4), and then again immediately following the last day of the intervention (day 18), 2 weeks (day 32), 1 month, 3 months and 6 months later.)
- Box and block test (BBT)(assessed at one baseline session (day 4), and then again immediately following the last day of the intervention (day 18), 2 weeks (day 32), 1 month, 3 months and 6 months later.)
- Modified Ashworth Scale(assessed at one baseline session (day 4), and then again immediately following the last day of the intervention (day 18), 2 weeks (day 32), 1 month, 3 months and 6 months later.)
- Testing motor MRC(assessed at one baseline session (day 4), and then again immediately following the last day of the intervention (day 18), 2 weeks (day 32), 1 month, 3 months and 6 months later.)
- Functional independence scale (MIF)(assessed at one baseline session (day 4), and then again immediately following the last day of the intervention (day 18), 2 weeks (day 32), 1 month, 3 months and 6 months later.)
- Motor Activity Log (MAL)(assessed at one baseline session (day 4), and then again immediately following the last day of the intervention (day 18), 2 weeks (day 32), 1 month, 3 months and 6 months later.)