Exploring Cerebellar Inhibition of the Motor Cortex in Stroke Patients

Suspended

• Conditions: Stroke

• Registration Number: NCT02401698
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2014-11-26
• Study Start: 2014-12
• Study First Submitted QC: 2015-03-24
• Study First Posted: 2015-03-30
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-08
• Last Update Posted: 2016-01-11
• Primary Completion: 2016-02
• Study Completion: 2016-04

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 8

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Motor function on the Upper Limb Fugl-Meyer Scale and the motor evoked potentials (MEP) on the Transcranial Magnetic Stimulation.	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.

Trial Locations

Locations (1)

Centro de Pesquisa Clínica do Instituto de Medicina e Reabilitação do HCFMUSP; 🇧🇷 Sao Paulo, Brazil