Transcranial Direct Current Stimulation (tDCS) Improves Functional Outcomes in Acute Stroke Patients

Study Overview
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Brief Summary
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Acute stroke patient will undergo one month (20 sessions) of physical therapy and anodal tDCS. Patients will undergo functional outcomes measured at 48h post onset, 7,14,21,28 days, 3 and 6 months and one year post onset.

Detailed Description
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Recruitment : Patients with acute stroke (24-48h after stroke) who have upper and / or lower sensorimotor deficits • Treatment : After being selected according to the inclusion and exclusion criteria of this study, patients will be randomized and placed in one of two groups: placebo (P) or transcranial anodic stimulation (A). Once placed in one of two groups, patients will all receive intensive physiotherapy for functional improvement in order to increase motor, postural and motor control. This physiotherapy will be established 5 times a week (Monday to Friday). In addition to physiotherapy, the patient will have electrodes placed on his head, attached via a system of straps, to deliver either a continuous current (A) or no current (P) and at a rate of 5 times per week for 4 weeks. Neither the physiotherapist nor the patient will know what treatment he will have received. • Evaluations and measurements: Patients will be required to perform functional tests of the upper limb (Wolf Motor Function Test (WMFT)), filmed and timed, a test of spasticity (Tardieu) as well as to answer certain questionnaires concerning their perception of the evolution of the disease and their disability (Stroke Impact Scale, Barthel Index), their emotional state (HADS), if they have experienced side effects, sensitivity test with monofilaments or Semmes and Weinstein test, the Fugl Meyer, the timed up and go, the test of 10m, the four step square test, the berg balance scale, the postural assessment scale and the trunk impairment scale. These evaluations will take place at Day 0 (corresponding to the first day after the 48h of strict bedtime), Day 7, 15, 30, 90, 6 months and 1 year. They will be done in two stages, on two successive days, so as not to exhaust the patient.

Official Title
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Transcranial Direct Current Stimulation ASsociated With Physical-therapy In Acute Stroke Patients - the tDCS ASAP - a Randomized, Triple Blind, Sham-controlled Study ?

Conditions
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Stroke, Acute

Intervention / Treatment
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* Device: tDCS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Woman or man Between 18 and 80 years old First ever stroke Capable of signing the consent form Exclusion Criteria: One on the TSST (in high and relatively high risk sections) Previous neurological or orthopedic pathologies affecting limbs Cognitive deficits

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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
Interventional Model Description: randomized, triple blind, sham controlled
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anodal tDCS<br>Patients will receive 20min anodal tDCS | Device: tDCS<br>* 20 minutes of anodal tDCS (C3/FP2 or C4/FP1 depending on side of lesion) 2mA or sham<br>* Other names: Non invasive brain stimulation;|
| Sham Comparator: Sham tDCS<br>Patients will receive 20 minutes of Sham anodal tDCS | Device: tDCS<br>* 20 minutes of anodal tDCS (C3/FP2 or C4/FP1 depending on side of lesion) 2mA or sham<br>* Other names: Non invasive brain stimulation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wolf Motor Function Test Change | Functional outcome of the paretic limb | 48 hours post onset, 7, 14, 21 and 28 days post onset, 3 and 6 months post onset and 1 year post onset | 
| Semmes Weinstein Change | Monofilament sensory test | 48 hours post onset, days 7, 14, 21 and 28 post onset, 3 and 6 months post onset and 1 year post onset | 
| Timed up and go Change | walking test | 48 hours post onset, days 7, 14, 21 and 28 post onset, 3 and 6 months post onset and 1 year post onset | 
| 10 meter walk test Change | Walking speed test | 48 hours post onset, days 7, 14, 21 and 28 post onset, 3 and 6 months post onset and 1 year post onset | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tardieu spasticity scale Change | spasticity scale, the higher the score the higher the spasticity | 48 hours post onset, days 7, 14, 21 and 28 post onset, 3 and 6 months post onset and 1 year post onset | 
| Stroke impact scale Change | Scale measuring impact of stroke on life, the higher the score the higher the worse off the patient is | 48 hours post onset, days 7, 14, 21 and 28 post onset, 3 and 6 months post onset and 1 year post onset | 
| HADS Change | Depression and anxiety scale, the higher the score the higher the more depressed or anxious the patient is | 48 hours post onset, days 7, 14, 21 and 28 post onset, 3 and 6 months post onset and 1 year post onset | 
| Fugl Meyer Change | Upper and lower limb motor outcomes, the higher the score the higher the better the patient is | 48 hours post onset, days 7, 14, 21 and 28 post onset, 3 and 6 months post onset and 1 year post onset | 
| 4 square step test Change | Balance test, the higher the score the higher the worse the patient is | 48 hours post onset, days 7, 14, 21 and 28 post onset, 3 and 6 months post onset and 1 year post onset | 
| Berg Balance scale Change | Balance test, the higher the score the higher the score, the better the patient is | 48 hours post onset, days 7, 14, 21 and 28 post onset, 3 and 6 months post onset and 1 year post onset | 
| Postural assessement scale Change | Balance test, the higher the score the higher the better the patient is | 48 hours post onset, days 7, 14, 21 and 28 post onset, 3 and 6 months post onset and 1 year post onset | 
| Trunk impairment scale Change | balance test, the higher the score the higher the better the patient is | 48 hours post onset, days 7, 14, 21 and 28 post onset, 3 and 6 months post onset and 1 year post onset | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tDCS, WMFT, Semmes Weinstein, Acute stroke