Cerebrovascular AccidentNCT02432521
Predictors of Treatment Response of Motor Sequels After a Stroke
An observational study of Cerebrovascular Accident, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebrovascular Accident
- What is being tested?
- Conventional rehabilitation program from IMREA
- How many people
- 49 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2015to Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Centro de Pesquisa Clínica do Instituto de Medicina e Reabilitação do HCFMUSP
São Paulo, 05716-150
About this study
Official title: 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.
Read the 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
- Being tested
- Conventional rehabilitation program from IMREA
- Keywords
- stroke, transcranial magnetic stimulation (TMS), Electroencephalography (EEG), Cerebrovascular Accident, Brain Vascular Accident
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional rehabilitation program from IMREAOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in motor cortex excitability as measured by Transcranial magnetic stimulation (TMS)
A noninvasive brain stimulation techniques suitable for measuring the motor cortex excitability
Measured: 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)
The record of the brain's spontaneous electrical activity
Measured: At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
Secondary outcomes (18)
cinematic variables analyzed with robotic
speed, acceleration, articular angulation, time-to-point, task execution time, target displacement
Measured: At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
Mini-mental State Examination
Measured: At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
Visual Analog Scale of Pain
Measured: At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
Verbal fluency test
Measured: At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
Boston naming test
Measured: At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
Hamilton Rating scale of depression
Measured: At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
The Kinesthetic and visual imagery questionnaire (KVIQ)
Measured: At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
National Institutes of Health Stroke Scale (NIHSS)
Measured: At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
Stroke Impact Scale (SIS)
Measured: At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
Von Frey test
Measured: At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
Functional Independence Measure
Measured: At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
Epworth Sleepiness Scale
Measured: At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
Fugl-Meyer Assessment
Measured: At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
Medical Research Council Scale
Measured: At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
Modified Ashworth Scale
Measured: At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
Finger Tapping
Measured: At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
Jebsen-Taylor Hand Function Test
Measured: At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
Purdue Pegboard test
Measured: At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2015 (estimated)
- Study startMar 2015
- Primary completionJun 2017
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular AccidentStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linamara Rizzo Battistella, MD PhD, University of Sao Paulo General Hospital
- Investigators
- Linamara Battistella, Md PhD, 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02432521
- Sponsor's protocol ID
- 35583814.1.0000.0068_CAAE
- Status last verified
- Jul 2017
- First submitted
- 16 Apr 2015
- Last updated
- 5 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23319486Stinear 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.
PubMed 21035399
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Treatment Response of Motor Sequels After a Cerebrovascular Accident
- ClinicalTrials.gov ID
- NCT02432521
- Acronym / sponsor ID
- 35583814.1.0000.0068_CAAE
- Conditions
- Cerebrovascular Accident
- Keywords
- stroke, transcranial magnetic stimulation (TMS), Electroencephalography (EEG), Cerebrovascular Accident, Brain Vascular Accident
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jul 2017 (estimated)
- First posted
- 4 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional rehabilitation program from IMREAThe 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. | Other | – |
Primary outcome
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
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
18 secondary outcomes
cinematic variables analyzed with robotic
Time frame: 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
Visual Analog Scale of Pain
Time frame: 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
Boston naming test
Time frame: 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
The Kinesthetic and visual imagery questionnaire (KVIQ)
Time frame: 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
Stroke Impact Scale (SIS)
Time frame: 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
Functional Independence Measure
Time frame: 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
Fugl-Meyer Assessment
Time frame: 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
Modified Ashworth Scale
Time frame: 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
Jebsen-Taylor Hand Function Test
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2017.
- Background: PubMed 23319486Norrving 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.
- Background: PubMed 21035399Stinear 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linamara Battistella, Md PhD 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebrovascular Accident, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02432521, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2017.