Predictors of Treatment Response of Motor Sequels After a Stroke

Active, not recruiting

Phase N/A Results N/A

Trial Description

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

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.

Conditions

Interventions

  • Conventional rehabilitation program from the Institute of Physical Medicine and Rehabilitation (IMREA) Other
    Intervention Desc: 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.
  • Conventional rehabilitation program from IMREA Other
    Intervention Desc: 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.

Trial Design

  • Observation: Ecologic or Community
  • Perspective: Prospective
  • Sampling: Non-Probability Sample

Trial Population

Patients of hemiplegia ambulatory from the Institute of Physical Medicine and Rehabilitation (IMREA) from the Clinics Hospital (HC) of the Medical School of the University of Sao Paulo (USP)

Outcomes

Type Measure Time Frame Safety Issue
Primary Change in motor cortex excitability as measured by Transcranial magnetic stimulation (TMS) At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline No
Primary Change in spontaneous electrical brain activity as assessed by Electroencephalogram (EEG) At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline No
Secondary cinematic variables analyzed with robotic At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline No
Secondary Mini-mental State Examination At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline No
Secondary Visual Analog Scale of Pain At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline No
Secondary Verbal fluency test At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline No
Secondary Boston naming test At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline No
Secondary Hamilton Rating scale of depression At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline No
Secondary The Kinesthetic and visual imagery questionnaire (KVIQ) At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline No
Secondary National Institutes of Health Stroke Scale (NIHSS) At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline No
Secondary Stroke Impact Scale (SIS) At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline No
Secondary Von Frey test At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline No
Secondary Functional Independence Measure At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline No
Secondary Epworth Sleepiness Scale At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline No
Secondary Fugl-Meyer Assessment At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline No
Secondary Medical Research Council Scale At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline No
Secondary Modified Ashworth Scale At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline No
Secondary Finger Tapping At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline No
Secondary Jebsen-Taylor Hand Function Test At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline No
Secondary Purdue Pegboard test At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline No

Sponsors