Exploring Cerebellar Inhibition of the Motor Cortex in Stroke Patients

Sponsor
University of Sao Paulo General Hospital (Other)
Overall Status
Suspended
CT.gov ID
NCT02401698
Collaborator
(none)
8
1
16
0.5

Study Details

Study Description

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 Phase
  • 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 Design

Study Type:
Observational
Anticipated 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 :
Dec 1, 2014
Anticipated Primary Completion Date :
Feb 1, 2016
Anticipated Study Completion Date :
Apr 1, 2016

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT02401698
Other Study ID Numbers:
  • 36990314.4.0000.0068
First Posted:
Mar 30, 2015
Last Update Posted:
Jan 11, 2016
Last Verified:
Jan 1, 2016
Keywords provided by University of Sao Paulo General Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 11, 2016