Predictors of Treatment Response of Motor Sequels After a Stroke

Cerebrovascular Accident Clinical Trial

Official title:

Predictors of Treatment Response of Motor Sequels After a Cerebrovascular Accident

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02432521
• Other study ID #: 35583814.1.0000.0068_CAAE
• Status: Active, not recruiting
• Phase: N/A
• First received: April 16, 2015
• Last updated: July 3, 2017
• Start date: March 2015
• Est. completion date: July 2017

Study information

• Verified date: July 2017
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 49
• Est. completion date: July 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Stroke

Intervention

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.

Locations

Country	Name	City	State
Brazil	Centro de Pesquisa Clínica do Instituto de Medicina e Reabilitação do HCFMUSP	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

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. Review. — View Citation

Stinear C. Prediction of recovery of motor function after stroke. Lancet Neurol. 2010 Dec;9(12):1228-32. doi: 10.1016/S1474-4422(10)70247-7. Epub 2010 Oct 27. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Mini-mental State Examination		At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
Secondary	Visual Analog Scale of Pain		At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
Secondary	Verbal fluency test		At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
Secondary	Boston naming test		At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
Secondary	Hamilton Rating scale of depression		At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
Secondary	The Kinesthetic and visual imagery questionnaire (KVIQ)		At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
Secondary	National Institutes of Health Stroke Scale (NIHSS)		At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
Secondary	Stroke Impact Scale (SIS)		At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
Secondary	Von Frey test		At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
Secondary	Functional Independence Measure		At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
Secondary	Epworth Sleepiness Scale		At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
Secondary	Fugl-Meyer Assessment		At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
Secondary	Medical Research Council Scale		At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
Secondary	Modified Ashworth Scale		At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
Secondary	Finger Tapping		At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
Secondary	Jebsen-Taylor Hand Function Test		At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
Secondary	Purdue Pegboard test		At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline