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Exploring Cerebellar Inhibition of the Motor Cortex in Stroke Patients

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ClinicalTrials.gov Identifier: NCT02401698
Recruitment Status : Suspended (To perform a interim analyzes)
First Posted : March 30, 2015
Last Update Posted : January 11, 2016
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

Brief Summary:
The past 10 years of research in post stroke patients have shown certain types of rehabilitation can help neuronal plasticity of the brain. Transcranial magnetic stimulation (TMS) can be used to monitor this plasticity by mapping the brain's function (measuring brain activity). Recent research suggests that TMS can be used for both prognosis (determining future function) and to determine what type of rehabilitation therapy will work best after stroke. The purposes of this research study are to: 1) determine changes in cerebellar activity after motor cortical stroke 2) compare changes in recovery of motor function with changes in cerebellar - motor cortex connections; 3) determine the ability of TMS to "predict" functional outcome after stroke. The primary hypotheses are: 1) functional recovery will be correlated with TMS changes (as measure of motor threshold (MT), intracortical inhibition, cerebellar cerebral inhibition (CBI), motor evoked potentials (MEPs) and recruitment curves; 2) baseline TMS will predict future functional outcomes.

Condition or disease Intervention/treatment
Stroke Other: Functional clinical and TMS diagnostic

Detailed Description:
Transcranial magnetic stimulation (TMS) can be used to monitor this plasticity by mapping the brain's function (measuring brain activity). Recent research suggests that TMS can be used for both prognosis (determining future function) and to determine what type of rehabilitation therapy will work best after stroke. The purposes of this research study are to: 1) determine changes in cerebellar activity after motor cortical stroke 2) compare changes in recovery of motor function with changes in cerebellar - motor cortex connections; 3) determine the ability of TMS to "predict" functional outcome after stroke. The primary hypotheses are: 1) functional recovery will be correlated with TMS changes (as measure of motor threshold (MT), intracortical inhibition, cerebellar cerebral inhibition (CBI), motor evoked potentials (MEPs) and recruitment curves; 2) baseline TMS will predict future functional outcomes.

Study Type : Observational
Estimated Enrollment : 8 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Exploring Cerebellar Inhibition of the Motor Cortex in Stroke Patients
Study Start Date : December 2014
Estimated Primary Completion Date : February 2016
Estimated Study Completion Date : April 2016

Intervention Details:
  • Other: Functional clinical and TMS diagnostic
    Functional clinical and TMS diagnostic examination to evaluate corticospinal motor tract activity and corticocerebellar tract activity and its relation with stroke recovery


Primary Outcome Measures :
  1. Motor function on the Upper Limb Fugl-Meyer Scale and the motor evoked potentials (MEP) on the Transcranial Magnetic Stimulation. [ Time Frame: 3 months ]
    To explore the relationship between the cerebellar brain inhibition - CBI and motor function of upper extremities of patients with stroke. The cerebellar brain inhibition will be assessed by Transcranial Magnetic Stimulation (TMS) and the motor function of the upper extremities by the Upper Limb Fugl-Meyer Scale.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
8 a 19 patients who have suffered a unilateral ischemic stroke up to 2 years and who will undergo motor rehabilitation at the study center will be asked to participate in the study
Criteria

Inclusion Criteria:

  • one sided ischemic stroke confirmed by radiology
  • adults

Exclusion Criteria:

  • brainstem stroke
  • cerebellar stroke
  • seizure with the recent stroke
  • any history of uncontrolled seizure
  • pregnancy or planning on getting pregnant during the next year
  • recent history (past year) of alcohol and drug abuse (due to lack of follow up) Other criteria include TMS exclusions: aneurysm clips, previous surgery over motor cortex, open craniotomy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02401698


Locations
Brazil
Centro de Pesquisa Clínica do Instituto de Medicina e Reabilitação do HCFMUSP
Sao Paulo, Brazil, 05716-150
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
Principal Investigator: Linamara Rizzo Battistella, MD PhD University of Sao Paulo

Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02401698     History of Changes
Other Study ID Numbers: 36990314.4.0000.0068
First Posted: March 30, 2015    Key Record Dates
Last Update Posted: January 11, 2016
Last Verified: January 2016

Keywords provided by University of Sao Paulo General Hospital:
Stroke
Transcranial Magnetic Stimulation
Neuronal Plasticity
Rehabilitation

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases