Effects of Transcranial Direct Current Stimulation on Upper Limb Motor Rehabilitation in Chronic Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Cortical excitability measured by Transcranial Magnetic Stimulation (TMS)
研究概览
简要总结
This study is a randomized double-blinded trial investigating the effect of Transcranial Direct Current stimulation (tDCS) on upper limb motor function rehabilitation in chronic stroke patients.
51 subjects will be recruited from National University Hospital (NUH) and be randomized to receive one of the followings:
- Group 1 will receive 1 mA anodal tDCS stimulation to the ipsilesional M1 of cortical representation of the affected upper limb;
- Group 2 to receive 1mA anodal tDCS to the contralesional premotor cortex;
- Group 3 to receive sham tDCS stimulation with anode placed over the scalp area corresponding to ipsilesional M1.
tDCS will be performed once a day together with standardized occupational therapy (GRASP) for 20 sessions within 30 days. Group 1 and Group 2 will receive tDCS for 20 minutes during each session, while Group 3 only receives the current stimulation for 20 seconds. GRASP will be performed daily together with tDCS, either concurrently with or immediately after tDCS stimulation.
The outcome measures will be measured at baseline, after intervention and 1 month after intervention, including:
- TMS measurement of corticospinal excitability;
- functional MRI scan;
- High density EEG (HD-EEG) evaluation;
- Clinical measures on upper limb motor function;
- Cognitive tests.
详细描述
This study is a randomized double-blinded trial investigating the effect of Transcranial Direct Current stimulation (tDCS) on upper limb motor function rehabilitation in chronic stroke patients.
51 subjects will be recruited from National University Hospital (NUH). Once subject is identified to be eligible for the study and is agreeable to participate into the study, the following will be measured/performed:
- TMS measurement of corticospinal excitability: resting motor threshold and/or active motor threshold, intracortical facilitation, short interval intracortical inhibition, silent period.
- MRI scan: Participants will go through the following image acquisition procedures at NUS TMR (Centre for Translational MR Research): 1) a functional MRI scans for brain activity together with motor task. 2) a 3D MPRAGE sequence for brain structure. 3) an advanced multishell high-resolution diffusion MRI for characterizing brain microstructure and extracellular space. 4) a FLAIR scan to measure white matter hyperintensity. Both functional and anatomical image acquisition will be undertaken using but not limited to gradient echo EPI sequence or its modified version (Feinberg & Setsompop, 2013). Signal stability during imaging is assured by a daily prescan QC routine. Contrast MRI will not be performed in this study. The MRI scan will take about 1 hours. The whole procedure including briefing and preparation will be about 1.5 hours.
- High density EEG (HD-EEG) evaluation of the electrical activity of the brain.
- Clinical measures on upper limb motor function:
- upper extremity portion of Fugl-Meyer Assessment (UE-FMA)
- Action Research Arm test (ARAT)
- Modified Ashworth scale for spasticity (MAS)
- Isometric elbow flexion strength
- Handgrip strength
- Cognitive tests:
- Digit Span Task
- Digit Symbol Modalities Task
- Trail-making test (TMT)-A &B
- Clock-Drawing Test (CDT)
- Controlled Oral Word Association Test (COWAT) -animals & FAS
- Mini-Mental State Exam (MMSE)
- Rey Auditory Verbal Learning Test (RAVL)
- Spatial span forward/backward test
- Visuospatial Paired Associate Learning (VPA)
- Randomization: Subject will be randomized into 3 groups using Microsoft Excel, to receive different types of stimulation:
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)
盲法说明
Participant and outcome assessor will be blinded to the tDCS stimulation protocol that they will be receiving.
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21-80 years old;
- •First ever stroke, 6 months to 2 years after stroke onset;
排除标准
- •Any metal implants inside the body that are contraindications of MRI scan;
- •cardiac pacemakers;
- •History of epilepsy;
- •Sensorimotor disturbance due to other causes other than stroke;
- •Claustrophobia;
- •Uncontrolled medical conditions including hypertension, diabetes mellitus and unstable angina;
- •Major depression and a history of psychotic disorders;
- •Terminal diagnosis with life expectancy <=1 year. Any metal implants inside the body that are contraindications of MRI scan;
- •3. cardiac pacemakers;
- •History of epilepsy;
- •Sensorimotor disturbance due to other causes other than stroke;
- •Claustrophobia;
- •Uncontrolled medical conditions including hypertension, diabetes mellitus and unstable angina;
- •Major depression and a history of psychotic disorders;
- •Terminal diagnosis with life expectancy <=1 year.
研究组 & 干预措施
Anodal tDCS stimulation to the ipsilesional M1
Participant will receive 1 mA anodal tDCS stimulation to the ipsilesional M1 of cortical representation of the affected upper limb.
Cathode will be used as reference electrode and placed over the supraorbital area contralateral to the anode. tDCS stimulation will be conducted daily for 20 sessions in consecutive days in the 4th month after stroke, with each session lasting for 20 minutes and combined with online occupational therapy training.
干预措施: transcranial current stimulation (Device)
Anodal tDCS stimulation to the ipsilesional M1
Participant will receive 1 mA anodal tDCS stimulation to the ipsilesional M1 of cortical representation of the affected upper limb.
Cathode will be used as reference electrode and placed over the supraorbital area contralateral to the anode. tDCS stimulation will be conducted daily for 20 sessions in consecutive days in the 4th month after stroke, with each session lasting for 20 minutes and combined with online occupational therapy training.
干预措施: GRASP (Behavioral)
Anodal tDCS to the contralesional premotor cortex
Participant will receive 1mA anodal tDCS to the contralesional premotor cortex. Cathode will be used as reference electrode and placed over the supraorbital area contralateral to the anode. tDCS stimulation will be conducted daily for 20 sessions in consecutive days in the 4th month after stroke, with each session lasting for 20 minutes and combined with online occupational therapy training.
干预措施: transcranial current stimulation (Device)
Anodal tDCS to the contralesional premotor cortex
Participant will receive 1mA anodal tDCS to the contralesional premotor cortex. Cathode will be used as reference electrode and placed over the supraorbital area contralateral to the anode. tDCS stimulation will be conducted daily for 20 sessions in consecutive days in the 4th month after stroke, with each session lasting for 20 minutes and combined with online occupational therapy training.
干预措施: GRASP (Behavioral)
Sham tDCS
Participant will receive sham tDCS stimulation with anode placed over the scalp area corresponding to ipsilesional M1.
Cathode will be used as reference electrode and placed over the supraorbital area contralateral to the anode. tDCS stimulation will be conducted daily for 20 sessions in consecutive days in the 4th month after stroke, with each session lasting for 20 minutes and combined with online occupational therapy training.
干预措施: transcranial current stimulation (Device)
Sham tDCS
Participant will receive sham tDCS stimulation with anode placed over the scalp area corresponding to ipsilesional M1.
Cathode will be used as reference electrode and placed over the supraorbital area contralateral to the anode. tDCS stimulation will be conducted daily for 20 sessions in consecutive days in the 4th month after stroke, with each session lasting for 20 minutes and combined with online occupational therapy training.
干预措施: GRASP (Behavioral)
结局指标
主要结局
Cortical excitability measured by Transcranial Magnetic Stimulation (TMS)
时间窗: Month 2
measures of cortical excitability for those without TMS contraindications
Modified Ashworth scale for spasticity (MAS)
时间窗: Month 2
Test for muscle spasticity. 6 point scale, Scores range from 0 to 4 (namely 0, 1, 1+, 2, 3 and 4), where lower scores represent normal muscle tone and higher scores represent spasticity or increased resistance to passive movement.
neural excitability measured by Magnetic resonance imaging (MRI) scan
时间窗: Month 2
Participants will go through one of the following image acquisition procedures 1) a functional MRI scans for brain activity together with motor task. 2) a 3D MPRAGE sequence for brain structure. 3) an advanced multishell high-resolution diffusion MRI for characterizing brain microstructure and extracellular space. 4) a FLAIR scan to measure white matter hyperintensity. Both functional and anatomical image acquisition will be undertaken using but not limited to gradient echo EPI sequence or its modified version.
Action Research Arm Test
时间窗: Month 2
Test for upper extremity performance (coordination, dexterity and functioning). Minimum score 0, Maximum score 57, the higher the score the better the upper limb function.
neural excitability measured by electroencephalogram (EEG)
时间窗: Month 2
High density EEG (electroencephalogram) evaluation of the electrical activity of the brain
upper extremity motor function using Fugl-Meyer scale
时间窗: Month 2
Upper limb function, Minimum score 0, Maximum score 66, the higher the score the better the upper limb function.
Cortical excitability measured by Transcranial Magnetic Stimulation (TMS)
时间窗: Month 0
measures of cortical excitability for those without TMS contraindications
Cortical excitability measured by Transcranial Magnetic Stimulation (TMS)
时间窗: Month 1
measures of cortical excitability for those without TMS contraindications
Action Research Arm Test
时间窗: Month 1
Test for upper extremity performance (coordination, dexterity and functioning). Minimum score 0, Maximum score 57, the higher the score the better the upper limb function.
Action Research Arm Test
时间窗: Month 0
Test for upper extremity performance (coordination, dexterity and functioning). Minimum score 0, Maximum score 57, the higher the score the better the upper limb function.
neural excitability measured by Magnetic resonance imaging (MRI) scan
时间窗: Month 0
Participants will go through one of the following image acquisition procedures 1) a functional MRI scans for brain activity together with motor task. 2) a 3D MPRAGE sequence for brain structure. 3) an advanced multishell high-resolution diffusion MRI for characterizing brain microstructure and extracellular space. 4) a FLAIR scan to measure white matter hyperintensity. Both functional and anatomical image acquisition will be undertaken using but not limited to gradient echo EPI sequence or its modified version.
neural excitability measured by electroencephalogram (EEG)
时间窗: Month 0
High density EEG (electroencephalogram) evaluation of the electrical activity of the brain
neural excitability measured by electroencephalogram (EEG)
时间窗: Month 1
High density EEG (electroencephalogram) evaluation of the electrical activity of the brain
upper extremity motor function using Fugl-Meyer scale
时间窗: Month 0
Upper limb function, Minimum score 0, Maximum score 66, the higher the score the better the upper limb function.
upper extremity motor function using Fugl-Meyer scale
时间窗: Month 1
Upper limb function, Minimum score 0, Maximum score 66, the higher the score the better the upper limb function.
Modified Ashworth scale for spasticity (MAS)
时间窗: Month 0
Test for muscle spasticity. 6 point scale, Scores range from 0 to 4 (namely 0, 1, 1+, 2, 3 and 4), where lower scores represent normal muscle tone and higher scores represent spasticity or increased resistance to passive movement.
Modified Ashworth scale for spasticity (MAS)
时间窗: Month 1
Test for muscle spasticity. 6 point scale, Scores range from 0 to 4 (namely 0, 1, 1+, 2, 3 and 4), where lower scores represent normal muscle tone and higher scores represent spasticity or increased resistance to passive movement.
次要结局
未报告次要终点