Clinical trial NCT02432521: Predictors of Treatment Response of Motor Sequels After a Stroke
Official title: Predictors of Treatment Response of Motor Sequels After a Cerebrovascular Accident
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebrovascular Accident
Keywords: stroke
transcranial magnetic stimulation (TMS)
Electroencephalography (EEG)
Cerebrovascular Accident
Brain Vascular Accident
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2015-05-04
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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)

Brief summary: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in motor cortex excitability as measured by Transcranial magnetic stimulation (TMS)
timeFrame: At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
measure: Change in spontaneous electrical brain activity as assessed by Electroencephalogram (EEG)
timeFrame: At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
Secondary outcomes:
measure: cinematic variables analyzed with robotic
timeFrame: At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
measure: Mini-mental State Examination
timeFrame: At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
measure: Visual Analog Scale of Pain
timeFrame: At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
measure: Verbal fluency test
timeFrame: At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
measure: Boston naming test
timeFrame: At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
measure: Hamilton Rating scale of depression
timeFrame: At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
measure: The Kinesthetic and visual imagery questionnaire (KVIQ)
timeFrame: At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
measure: National Institutes of Health Stroke Scale (NIHSS)
timeFrame: At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
measure: Stroke Impact Scale (SIS)
timeFrame: At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
measure: Von Frey test
timeFrame: At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
measure: Functional Independence Measure
timeFrame: At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
measure: Epworth Sleepiness Scale
timeFrame: At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
measure: Fugl-Meyer Assessment
timeFrame: At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
measure: Medical Research Council Scale
timeFrame: At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
measure: Modified Ashworth Scale
timeFrame: At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
measure: Finger Tapping
timeFrame: At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
measure: Jebsen-Taylor Hand Function Test
timeFrame: At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
measure: Purdue Pegboard test
timeFrame: At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Centro de Pesquisa Clínica do Instituto de Medicina e Reabilitação do HCFMUSP
Study officials:
affiliation: Head Professor, Medical School of the University of Sao Paulo, pos graduation program at the Medical Science of the Medical School of the University of Sao Paulo
name: Linamara Battistella, Md PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Norrving B, Kissela B. The global burden of stroke and need for a continuum of care. Neurology. 2013 Jan 15;80(3 Suppl 2):S5-12. doi: 10.1212/WNL.0b013e3182762397.
citation: Stinear C. Prediction of recovery of motor function after stroke. Lancet Neurol. 2010 Dec;9(12):1228-1232. doi: 10.1016/S1474-4422(10)70247-7. Epub 2010 Oct 27.