Association Between Brain Stimulations for the Rehabilitation of Chronic Stroke Patients

Study Overview
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Brief Summary
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Cerebrovascular accident (CVA) is a cerebrovascular disease with high incidence and morbidity in the Brazilian population, and is considered a major cause of disability in adults. Brain damage caused by stroke generates a maladaptive pattern of neural activity and modulation between the cerebral hemispheres, unbalancing in the inter-hemispheric inhibition. This condition affects patient's functional recovery. The aim of this study is to verify the effectiveness of repetitive transcranial magnetic stimulation Association (rTMS) in the cortex motor contralesional, Transcranial Direct Current Stimulation (tDCS) in the motor cortex ipsilesional and the association between these two types of brain stimulations on the upper limb recovery after stroke.

Official Title
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Association Between Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation for Chronic Stroke Patients Rehabilitation: a Randomized Clinical Trial.

Conditions
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Stroke

Intervention / Treatment
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* Device: tDCS
* Device: TMS
* Device: tDCS + TMS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subcortical stroke diagnosis, which has resulted in hemiparesis for at least 6 months and not more than 5 years (chronic condition); Ability to reach 60 degrees in the shoulder flexion Ability to completely extend the fingers in the affected upper limb; Minimal cognitive ability to understand commands; No current use of antiepileptic drugs for seizures. Exclusion Criteria: Painful shoulder, adhesive capsulitis or glenohumeral subluxation; Contraindication (presence of metallic implants) or risks for the Transcranial magnetic stimulation, as evaluated by means of a standard questionnaire;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: tDCS<br>Patients who will be treated with Transcranial direct-current stimulation (tDCS) in the ipsilesional motor cortex. | Device: tDCS<br>* Transcranial direct current stimulation (tDCS)<br>|
| Active Comparator: rTMS<br>Patients who will be treated with Magnetic brain stimulation (rTMS) in the contralesional motor cortex. | Device: TMS<br>* Transcranial magnetic stimulation<br>|
| Experimental: tDCS + rTMS<br>Patients who will be treated with the association between Transcranial direct-current stimulation (tDCS) and magnetic brain stimulation (rTMS), in the ipsilesional and contralesional motor cortex, respectively. | Device: tDCS + TMS<br>* Association between tDCS and TMS.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor Function by means of the Wolf Motor Function Test |  | change from pre to post (at least 10 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grip strength via hand dynamometer |  | change from pre to post (at least 10 days) | 
| Manual Dexterity by means of the Box and Block Test |  | change from pre to post (at least 10 days) | 
| Quality of Life by means of the Stroke Impact Scale |  | change from pre to post (at least 10 days) |