The Effect of tDCS Combined With Functional Task Training on Motor Recovery in Stroke Patients

Study Overview
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Brief Summary
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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).

Official Title
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The Effect of Transcranial Direct Current Stimulation Combined With Functional Task Training on Motor Recovery in Stroke Patients

Conditions
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Stroke, Stroke, Acute, Motor Function

Intervention / Treatment
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* Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
* Device: Transcranial Direct Current Stimulation (tDCS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18-90 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. Exclusion Criteria: 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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active<br> | Device: Repetitive Transcranial Magnetic Stimulation (rTMS)<br>* Subjects will either undergo (1) active low-frequency rTMS (1Hz continuous) prime with anodal Transcranial Direct Current Stimulation (tDCS) on the affected side combine with Constraint induced movement therapy. Each session will last 20 minutes.<br>Device: Transcranial Direct Current Stimulation (tDCS<br>* Subjects will either undergo sham Transcranial Direct Current Stimulation (tDCS) on the affected side combine with Constraint-induced movement therapy.<br>|
| Sham Comparator: Sham<br> | Device: Transcranial Direct Current Stimulation (tDCS<br>* Subjects will either undergo sham Transcranial Direct Current Stimulation (tDCS) on the affected side combine with Constraint-induced movement therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the neurophysiologic findings of cortical plasticity. | 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. | Before 10 sessions, before and after each session (every day), after 10 daily sessions and after 6 weeks | 
| To assess the motor function changes . | 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 | before 10 sessions, before and after each session (every day), after 10 daily sessions and after 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensory-motor function of the upper limb | This consists of a quantitative scale developed to measure (motor recovery, balance, sensation, and some joint function) recovery of the motor function of stroke patients. Measured through the Fugl-Meyer Rating Scale, which expressed in values from 0 to 66. | before 10 sessions, before and after each session (every day), after 10 daily sessions and after 30 days | 
| Degree of disability: | This consists of a quantitative scale developed to measured the disability caused by impairments in stroke patients. The Barthel Index Score (Activities of Daily Living) measured through ranges from 0 to 20, principally concerned with physical aspects of disability. | before 10 sessions, before and after each session (every day), after 10 daily sessions and after 30 days |