Transcranial Direct Current Stimulation, Improve Functional Motor Recovery, Affected Arm

Study Overview
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Brief Summary
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Overall goal of this study is to determine if transcranial direct current stimulation (tDCS) plus conventional occupational therapy improves functional motor recovery in the affected arm-hand in patients after an acute ischemic stroke compared to sham tDCS plus conventional occupational therapy, and to obtain information to plan a large randomized controlled trial.

Detailed Description
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Study design: Patients Successive admissions to the stroke service of the Veterans Affairs Medical Center with ischemic strokes will participate in this study. Eligibility criteria: Inclusion criteria: Unilateral, 1st acute stroke event within 4 weeks of admission to an in-patient rehabilitation facility Ischemic stroke documented clinically and by neuroimaging. Severe upper limb weakness (MRC grade of 2 or less at the shoulder joint) Medically stable from a cardio-respiratory stand point so that they can participate in daily therapies. Depressed patients will be included in the study (psychiatrist referral will be made if deemed necessary). Aphasic alert patients will be included in the study provided they were able to follow simple directions by verbal or gestural cues and provided with a written informed consent. Informed consent, from cognitively intact patients (admission Mini Mental Scale Examination [MMSE] greater than or equal to 21). When it is not possible for the patient to provide informed consent or patient is cognitively impaired with MMSE ≤ 20, proxy consent will be obtained from the next of kin (legal authorized representative) according to institutional IRB standards. Informed consent will be obtained by the admitting physicians. Exclusion criteria: Hemorrhagic strokes Patient's with an episode post-stroke seizure or history of epilepsy. Patients medically unstable, demented, or terminally ill (e.g., patients with stroke as a complication of a terminal cancer). On medications such as botox for spasticity or other medications known to enhance motor recovery such as d-amphetamine, Stroke patients with implanted pacemakers and defibrillators. Refusal to provide informed consent

Official Title
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Does Transcranial Direct Current Stimulation Improve Functional Motor Recovery in the Affected Arm-Hand in Patients After an Acute Ischemic Stroke: A Randomized Control Trial

Conditions
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Brain Infarction, Brain Ischemia

Intervention / Treatment
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* Device: t DC stimulation
* Device: tDCStimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Unilateral, 1st acute stroke event within 4 weeks of admission to an in-patient rehabilitation facility Ischemic stroke documented clinically and by neuroimaging. Severe upper limb weakness (MRC grade of 2 or less at the shoulder joint) Medically stable from a cardio-respiratory stand point so that they can participate in daily therapies. Depressed patients will be included in the study (psychiatrist referral will be made if deemed necessary). Aphasic alert patients will be included in the study provided they were able to follow simple directions by verbal or gestural cues and provided with a written informed consent. Informed consent, from cognitively intact patients (admission Mini Mental Scale Examination [MMSE] greater than or equal to 21). When it is not possible for the patient to provide informed consent or patient is cognitively impaired with MMSE ≤ 20, proxy consent will be obtained from the next of kin (legal authorized representative) according to institutional IRB standards. Informed consent will be obtained by the admitting physicians. Exclusion Criteria: Hemorrhagic strokes Patient's with an episode post-stroke seizure or history of epilepsy. Patients medically unstable, demented, or terminally ill (e.g., patients with stroke as a complication of a terminal cancer). On medications such as botox for spasticity or other medications known to enhance motor recovery such as d-amphetamine, Stroke patients with implanted pacemakers and defibrillators. Refusal to provide informed consent

Ages Eligible for Study
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Minimum Age: 19 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: t DC stimulation<br>Sham transcranial direct current stimulation tDCS induces slight short-lasting tingling with onset of the stimulation. These sensations usually fade away in seconds. Sham interventions are essential to blind the subject and the assessor in order to obtain unbiased assessment of intervention effects | Device: t DC stimulation<br>* tDCS is a non-invasive, non-painful technique that modulates cortical excitability. tDCS can induce intracerebral current flow that is sufficiently large to achieve changes in cortical excitability. Thus, tDCS can be applied to humans non-invasively and painlessly to induce focal, lasting but reversible shifts of cortical excitability.<br>* Other names: Sham transcranial DC brain stimulator;Device: tDCStimulation<br>* 1 mA of tDCS will be delivered through surface electrodes (25-35 cm2) to the unaffected motor cortex for 30 min prior to a patient's scheduled OT. In the sham group patient will receive stimulation for 30 seconds only.<br>* Other names: Experimental tDC stimulator;|
| Experimental: tDC stimulation<br>Actual DC stimulation | Device: t DC stimulation<br>* tDCS is a non-invasive, non-painful technique that modulates cortical excitability. tDCS can induce intracerebral current flow that is sufficiently large to achieve changes in cortical excitability. Thus, tDCS can be applied to humans non-invasively and painlessly to induce focal, lasting but reversible shifts of cortical excitability.<br>* Other names: Sham transcranial DC brain stimulator;Device: tDCStimulation<br>* 1 mA of tDCS will be delivered through surface electrodes (25-35 cm2) to the unaffected motor cortex for 30 min prior to a patient's scheduled OT. In the sham group patient will receive stimulation for 30 seconds only.<br>* Other names: Experimental tDC stimulator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Functional Independence Measure (TFIM) Change Scores | The Functional Independence Measure (FIM™) will measure the degree of disability. The FIM scale is a reliable and valid functional assessment measure widely used in rehabilitation settings. The FIM has 18 items and each item is scored on an ordinal scale ranging from 1 to 7. A FIM™ item score of seven is categorized as complete independence, while a score of one is total assist (patient performs less than 25% of task). The total FIM score (TFIM) quantifies level of independence and ranges from 18 (lowest) to 126 (highest) level of independence. | from baseline to 4-weeks of therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Action Research Arm Test (ARAT) Change Scores | The Action Research Arm Test (ARAT) is a standardized ordinal scale that measures upper extremity (arm and hand) function. This test assesses the ability to lift various sized objects to a height of 14.75 inches, move cylindrical shaped objects a distance of 14.75 inches, use pinch grasp to lift varying sized objects (such as a ball bearing, and a marble) between the thumb and the 3rd finger, and perform 3 gross upper extremity movements. Each upper extremity is evaluated individually. Score 0=no arm-hand movement and 57=normal | baseline to after 4-weeks of therapy | 
| Discharge Disposition | Patient discharged home or to sub-acute facility | after 4 weeks of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ischemic Strokes, t DC stimulation, Functional recovery