The Effect of Transcranial Direct Current Stimulation Combined With Functional Task Training on Motor Recovery in Stroke Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 主要终点
- To assess the neurophysiologic findings of cortical plasticity.
研究概览
简要总结
We propose to enhance the effects of brain plasticity using a powerful noninvasive technique for brain modulation consisting of navigated transcranial magnetic stimulation (TMS) priming with transcranial direct current stimulation (tDCS) in combination with motor-training-like constraint-induced movement therapy (CIMT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
盲法说明
Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 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 as noted in the radiological (or physician's) report;
- •the ability to extend =20° at the wrist and 10° at the metacarpophalangeal and interphalangeal joints of all digits;
- •participants must demonstrate adequate balance while wearing the restraint;
- •the ability to stand from a sitting position and the ability to stand for at least 2 minutes with or without upper extremity support;
- •weakness, defined as score of 15-55 (out of 66) on arm motor Fugl-Meyer (FM) scale; and
- •stroke onset more then 6 months prior to study enrollment.
排除标准
- •significant pre-stroke disability;
- •where applicable (a history of depression before the stroke);
- •any substantial decrease in alertness, language reception, or attention that might interfere with understanding the instructions for the motor testing;
- •excessive pain in any joint of the paretic extremity;
- •contraindications to single-pulse TMS (TMS will be used to measure cortical excitability) such as metal head implants;
- •advanced liver, kidney, cardiac, or pulmonary disease;
- •a terminal medical diagnosis consistent with survival 1 year;
- •coexistent major neurological or psychiatric disease (to decrease the number of confounders);
- •a history of significant drug abuse in the prior 6 months;
- •the use of certain neuropsychotropic drugs such as tricyclics, antidepressants, or 51 of 66 carbamazepine;
- •active enrollment in a separate intervention study targeting stroke recovery; (
- •previously applied constraint-induced motor therapy and/or tDCS treatment for stroke; and
- •a history of epilepsy before stroke (or episodes of seizures within the last six months).
结局指标
主要结局
To assess the neurophysiologic findings of cortical plasticity.
时间窗: Before 10 sessions, before and after each session (every day), after 10 daily sessions and after 6 weeks
Expressed as percent motor resting threshold and numerical values of motor evoked potential. The motor evoked potential (MEP) will be provided by twenty unconditioned stimuli (120% of motor resting threshould). The percentage of inhibition or facilitation for each before and after stimulation will be calculated.
To assess the motor function changes .
时间窗: before 10 sessions, before and after each session (every day), after 10 daily sessions and after 30 days
Change from motor hand function: ordinal variable measured through the Jebsen-Taylor Hand Function Test (JTHFT). The JTHFT has seven subsets which are writing, simulated page-turning, lifting small objects, simulated feeding, stacking, and lifting large, lightweight, and heavy objects
次要结局
- Degree of disability:(before 10 sessions, before and after each session (every day), after 10 daily sessions and after 30 days)
- Sensory-motor function of the upper limb(before 10 sessions, before and after each session (every day), after 10 daily sessions and after 30 days)