Predictors of Treatment Response of Motor Sequels After a Stroke

July 3, 2017 updated by: Linamara Rizzo Battistella, MD PhD, University of Sao Paulo General Hospital

Predictors of Treatment Response of Motor Sequels After a Cerebrovascular Accident

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

49

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 05716-150
        • Centro de Pesquisa Clínica do Instituto de Medicina e Reabilitação do HCFMUSP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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)

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in motor cortex excitability as measured by Transcranial magnetic stimulation (TMS)
Time Frame: At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
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)
Time Frame: At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
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
Time Frame: At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
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
Time Frame: At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
Visual Analog Scale of Pain
Time Frame: At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
Verbal fluency test
Time Frame: At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
Boston naming test
Time Frame: At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
Hamilton Rating scale of depression
Time Frame: At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
The Kinesthetic and visual imagery questionnaire (KVIQ)
Time Frame: At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
National Institutes of Health Stroke Scale (NIHSS)
Time Frame: At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
Stroke Impact Scale (SIS)
Time Frame: At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
Von Frey test
Time Frame: At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
Functional Independence Measure
Time Frame: At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
Epworth Sleepiness Scale
Time Frame: At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
Fugl-Meyer Assessment
Time Frame: At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
Medical Research Council Scale
Time Frame: At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
Modified Ashworth Scale
Time Frame: At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
Finger Tapping
Time Frame: At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
Jebsen-Taylor Hand Function Test
Time Frame: At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
Purdue Pegboard test
Time Frame: At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Investigators

  • Principal Investigator: Linamara Battistella, Md PhD, 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

June 1, 2017

Study Completion (Anticipated)

July 1, 2017

Study Registration Dates

First Submitted

April 16, 2015

First Submitted That Met QC Criteria

April 28, 2015

First Posted (Estimate)

May 4, 2015

Study Record Updates

Last Update Posted (Actual)

July 5, 2017

Last Update Submitted That Met QC Criteria

July 3, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 35583814.1.0000.0068_CAAE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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