Exploring Cerebellar Inhibition of the Motor Cortex in Stroke Patients

January 8, 2016 updated by: University of Sao Paulo General Hospital
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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

8

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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.

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

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 Rizzo Battistella, Md PhD, University of Sao Paulo

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

December 1, 2014

Primary Completion (Anticipated)

February 1, 2016

Study Completion (Anticipated)

April 1, 2016

Study Registration Dates

First Submitted

November 26, 2014

First Submitted That Met QC Criteria

March 24, 2015

First Posted (Estimate)

March 30, 2015

Study Record Updates

Last Update Posted (Estimate)

January 11, 2016

Last Update Submitted That Met QC Criteria

January 8, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 36990314.4.0000.0068

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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