Transcranial Direct Current Stimulation Associate to Constraint Induced Movement Therapy Over Premotor Cortex in Severe Stroke

Study Overview
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Brief Summary
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The purpose is to compare the effects of tDCS and constraint induced movement therapy (CIMT) in the premotor cortex vs. primary motor cortex in severely subacute stroke survivors.

Detailed Description
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Stroke survivors experience one or more movement-related impairments and activity limitations. In this sense, the premotor cortex (PMC) can be considered as an alternative locus for post-stroke rehabilitation. In relation to physical rehabilitation protocols, associate to neuromodulation, the investigators have chosen a standardized physical therapy protocol for this study, the Constraint Induced Movement Therapy (CIMT), which presents evidence of good therapeutic results. The investigators hypothesized that applying tDCS and CIMT over the PMC promotes motor restoration in stroke patients.

Conditions
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Stroke, Cerebrovascular Disorders, Cerebral Infarction

Intervention / Treatment
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* Device: Transcranial direct current stimulation
* Behavioral: Constraint-Induced Movement Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 65 years Diagnosis of unilateral, non-recurring, subacute stroke Participants also had to be able, by using any method of pinch, to grasp a washcloth from a table top, lift it up a few inches, and release it. Exclusion Criteria: Patients with difficulty to follow the procedures or understand the instructions; cognitive deficits tDCS criteria: use of modulators of the Central Nervous System drugs patients with implanted metallic or electronic devices pacemaker seizures pregnancy any other condition that might limit or interfere in the sensorimotor system

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active tdcs/M1<br>Anodal tDCS on primary motor cortex and CIMT (constraint induced movement therapy) | Device: Transcranial direct current stimulation<br> <br> Behavioral: Constraint-Induced Movement Therapy<br> <br> |
| Experimental: Active tdcs/Premotor<br>Anodal tDCS on premotor cortex and CIMT (constraint induced movement therapy) | Device: Transcranial direct current stimulation<br> <br> Behavioral: Constraint-Induced Movement Therapy<br> <br> |
| Sham Comparator: Sham tdcs<br>Sham tDCS and CIMT (constraint induced movement therapy) | Device: Transcranial direct current stimulation<br> <br> Behavioral: Constraint-Induced Movement Therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Independence measured by Barthel Index |  | Change for functional independence at baseline and week 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spasticity (Modified Ashworth Scale) |  | Baseline and Week 2 | 
| Muscle strength (Medical Research Council Scale) |  | Baseline and Week 2 |