Predictors of Treatment Response of Motor Sequels After a Stroke

Study Overview
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Brief Summary
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The cerebrovascular accident (CVA) is currently the leading cause of death in Brazil and it is estimated that there are about 62 million stroke survivors worldwide. Thus, the stroke sequels are a major public health problem not only in Brazil but in the world, with existing treatments often insufficient for complete recovery. Thus this study aims to identify predictors of different responses from rehabilitation therapy through the evaluation of clinical and neurophysiological data performed before and after treatment. For the neurophysiological study will be used the association of electroencephalogram (EEG) and transcranial magnetic stimulation (TMS). This last one will be performed in the baseline and after a single Transcranial direct current stimulation (tDCS) session, aiming to leverage the ability of those technics to analyze the cerebral plasticity. As a secondary objective: 1) Identify specific features of brain plasticity involved in recovery from stroke and discuss the possible implications of these findings in the therapeutic approach; 2) Search possible electrophysiological markers that can be used as surrogate outcome of stroke of motor sequel.

Detailed Description
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The cerebrovascular accident (CVA) is currently the leading cause of death in Brazil and it is estimated that there are about 62 million stroke survivors worldwide. Thus, the stroke sequels are a major public health problem not only in Brazil but in the world, with existing treatments often insufficient for complete recovery. Thus, the search for new treatments is necessary, as well as the need to optimize and individualize the existing treatments. Several approaches are being used in order to find predictors of the recovery of patients after the stroke, highlighting the most recent studies using magnetic resonance imaging (MRI) with tractography. However these studies have important limitations such as high cost, but mainly the low capacity of this technique to quantify brain plasticity known to play an important role in the recovery of stroke sequelae. Thus, techniques to measure brain plasticity theory offer the best potential to predict the resilience of post stroke injury, among which stands out transcranial magnetic stimulation (TMS). TMS is a noninvasive brain stimulation techniques suitable for measuring the motor cortex excitability which in turn is used as an indirect measure of brain plasticity. Another interesting approach is the combination of TMS with the study of neuronal function through the electroencephalogram (EEG). The EEG under the stroke, has also been suggested as sequelae recovery predictor, however in this scenario the association of these findings with TMS has not yet been explored. Thus this study aims to identify predictors of different responses from rehabilitation therapy through the evaluation of clinical and neurophysiological data performed before and after treatment. For the neurophysiological study will be used the association of electroencephalogram (EEG) and transcranial magnetic stimulation (TMS). This last one will be performed in the baseline and after a single Transcranial direct current stimulation (tDCS) session, aiming to leverage the ability of those technics to analyze the cerebral plasticity.

Official Title
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Predictors of Treatment Response of Motor Sequels After a Cerebrovascular Accident

Conditions
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Cerebrovascular Accident

Intervention / Treatment
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* Other: Conventional rehabilitation program from IMREA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical and radiological diagnosis (Functional magnetic Resonance (FMR) and/or Computerized tomography (TC) ) of the stroke; More than one month from the date of the stroke; Clinical stability; Signed and dated informed consent form. Exclusion Criteria: Disturbs that forbid the adherence in treatment; Subjects already undergoing in other researches; Pregnant women; Lesions that could affect the proposed therapy; The occurence of lesion or muscle,joint pain that could forbid the therapy; Destabilization of the clinical comorbidities.

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Conventional rehabilitation program from IMREA|The IMREA rehabilitation program lasts about 18 weeks and consists of two weekly sessions of 60 minutes of physical therapy, occupational therapy, as well as weekly sessions of speech therapy, nursing, nutrition, psychology and social work. Conventional therapies are typically composed of stretching and strengthening exercises both upper and lower limbs, mobilizations, functional training. The only fact that differ the subjects from the protocol from the patients from the IMREA Institute are the clinical and neurophysiological evaluations that will be performed before and after the end of the conventional rehabilitation program previously described.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in motor cortex excitability as measured by Transcranial magnetic stimulation (TMS) | A noninvasive brain stimulation techniques suitable for measuring the motor cortex excitability | At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline | 
| Change in spontaneous electrical brain activity as assessed by Electroencephalogram (EEG) | The record of the brain's spontaneous electrical activity | At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cinematic variables analyzed with robotic | speed, acceleration, articular angulation, time-to-point, task execution time, target displacement | At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline | 
| Mini-mental State Examination |  | At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline | 
| Visual Analog Scale of Pain |  | At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline | 
| Verbal fluency test |  | At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline | 
| Boston naming test |  | At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline | 
| Hamilton Rating scale of depression |  | At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline | 
| The Kinesthetic and visual imagery questionnaire (KVIQ) |  | At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline | 
| National Institutes of Health Stroke Scale (NIHSS) |  | At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline | 
| Stroke Impact Scale (SIS) |  | At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline | 
| Von Frey test |  | At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline | 
| Functional Independence Measure |  | At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline | 
| Epworth Sleepiness Scale |  | At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline | 
| Fugl-Meyer Assessment |  | At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline | 
| Medical Research Council Scale |  | At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline | 
| Modified Ashworth Scale |  | At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline | 
| Finger Tapping |  | At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline | 
| Jebsen-Taylor Hand Function Test |  | At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline | 
| Purdue Pegboard test |  | At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, transcranial magnetic stimulation (TMS), Electroencephalography (EEG), Cerebrovascular Accident, Brain Vascular Accident