Predictors of Treatment Response of Motor Sequels After a Stroke

NCT ID: NCT02432521

Last Updated: 2017-07-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 49 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2017-07-31

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.

Conditions

Cerebrovascular Accident

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Linamara Rizzo Battistella, MD PhD

Full Professor, Medical School of the University of Sao Paulo, Post Graduate Program in Medical Sciences of the Medical School of the University of Sao Paulo

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Linamara Battistella, Md PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Centro de Pesquisa Clínica do Instituto de Medicina e Reabilitação do HCFMUSP

São Paulo, , Brazil

Countries

Brazil

References

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.

Reference Type: BACKGROUND

PMID: 23319486 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21035399 (View on PubMed)

Other Identifiers

35583814.1.0000.0068_CAAE

Identifier Type: -

Identifier Source: org_study_id