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Clinical Trials/NCT02401698
NCT02401698
Suspended
N/A

Exploring Cerebellar Inhibition of the Motor Cortex in Stroke Patients

University of Sao Paulo General Hospital1 site in 1 country8 target enrollmentDecember 2014
ConditionsStroke

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke
Sponsor
University of Sao Paulo General Hospital
Enrollment
8
Locations
1
Primary Endpoint
Motor function on the Upper Limb Fugl-Meyer Scale and the motor evoked potentials (MEP) on the Transcranial Magnetic Stimulation.
Status
Suspended
Last Updated
10 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
December 2014
End Date
April 2016
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • one sided ischemic stroke confirmed by radiology

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.

Outcomes

Primary Outcomes

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.

Study Sites (1)

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