Exploring Cerebellar Inhibition of the Motor Cortex in Stroke Patients

NCT ID: NCT02401698

Last Updated: 2016-01-11

Basic Information

• Recruitment Status: SUSPENDED
• Total Enrollment: 8 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2016-04-30

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.

Conditions

Stroke

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

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

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Linamara Rizzo Battistella, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

Centro de Pesquisa Clínica do Instituto de Medicina e Reabilitação do HCFMUSP

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

36990314.4.0000.0068

Identifier Type: -

Identifier Source: org_study_id