Effects of Transcranial DC Stimulation Coupled With Constraint Induced Movement Therapy on Motor Function in Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Motor Activity Log Rating Scale
研究概览
简要总结
The purpose of this study is to determine whether a painless and noninvasive procedure called transcranial direct current stimulation (tDCS) combined with a method of physical therapy called constraint-induced movement therapy improves motor function in patients with chronic stroke. Research in healthy subjects has shown that when tDCS is combined with motor learning tasks, there is an increase in learning as compared to motor learning tasks only. The tDCS procedure sessions will be compared to sham (fake) procedure sessions, which is also called placebo stimulation. This study is double blind, which means neither the subjects nor researchers analyzing motor function will know if participants are receiving real tDCS stimulation or placebo. Only the person performing the procedure will know which one participants are receiving. Only by comparing the tDCS procedure to a sham (placebo) procedure can we understand if the tDCS actually improves motor function.
We hypothesize that tDCS will enhance the effects of constraint-induced movement therapy on motor recovery in chronic stroke patients.
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
- •First time clinical ischemic or hemorrhagic cerebrovascular accident (radiologically confirmed)
- •Demonstrates adequate balance while wearing a hand restraint on the unaffected arm
- •Ability to stand from a sitting position and ability to stand with or without upper extremity support
- •Stroke onset at least 6 months prior to study enrollment
排除标准
- •Significant pre-stroke disability
- •Any substantial decrease in alertness, language reception, or attention that might interfere with understanding instructions for motor testing
- •Excessive pain in any joint of the paretic extremity
- •A terminal medical diagnosis consistent with survival of less than 1 year
- •Advanced liver, kidney, cardiac, or pulmonary disease
- •Coexistent major neurological or psychiatric disease (including epilepsy)
- •A history of significant alcohol or drug abuse in the prior 3 years
- •Use of neuropsychotropic drugs - such as antidepressants
- •Patients may not be actively enrolled in a separate intervention study targeting stroke recovery
- •Patients may not have already received constraint-induced movement therapy and/or tDCS treatment for stroke
研究组 & 干预措施
1
Each subject will receive 14 days (2 week period: 10 weekdays and 2 weekends) of constraint induced movement therapy. In addition, on the 10 weekdays during the treatment period, the subjects will come into the laboratory and receive up to 6 hours per day of training of the affected arm in a variety of tasks. At the beginning of each of the 10 weekday training sessions, participants will receive 40 minutes of active tDCS over the primary motor cortex.
干预措施: Active transcranial Direct Current Stimulation / Constraint Induced Movement Therapy (Device)
2
Each subject will receive 14 days (2 week period: 10 weekdays and 2 weekends) of constraint induced movement therapy. In addition, on the 10 weekdays during the treatment period, the subjects will come into the laboratory and receive up to 6 hours per day of training of the affected arm in a variety of tasks. At the beginning of each training day tDCS will be applied for 40 minutes with the current active for only 30 seconds over the primary motor cortex.
干预措施: Sham transcranial Direct Current Stimulation / Constraint Induced Movement Therapy (Device)
结局指标
主要结局
Motor Activity Log Rating Scale
时间窗: Baseline, Treatment Days 1,5,10 and Follow Up
Jebsen-Taylor Hand Function Test
时间窗: Baseline, Treatment days 1,5,10, Follow Up
Beck Depression Inventory
时间窗: Baseline, Treatment days 1,5,10 and Follow up
Visual Analogue Scale for Anxiety
时间窗: Baseline, Treatment days 1,5,10 and Follow Up
次要结局
- Fugl Meyer Assessment of Motor Recovery(Baseline Assessment)
- Barthel Index Score(Baseline Assessment)
- Modified Ashworth Scale(Baseline Assessment)
研究者
Felipe Fregni
Study Principal Investigator
Beth Israel Deaconess Medical Center