Exploring Cerebellar Inhibition of the Motor Cortex in Stroke Patients

NCT02401698 | Suspended DMC

• 1 other identifier: 36990314.4.0000.0068
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Stroke; Transcranial Magnetic Stimulation; Neuronal Plasticity; Rehabilitation

Outcome Measures

Primary Outcomes (1)

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

  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

Interventions

Functional clinical and TMS diagnostic OTHER

Functional clinical and TMS diagnostic examination to evaluate corticospinal motor tract activity and corticocerebellar tract activity and its relation with stroke recovery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• one sided ischemic stroke confirmed by radiology
• adults

You may not qualify if:

• brainstem stroke
• cerebellar stroke
• seizure with the recent stroke
• any history of uncontrolled seizure
• pregnancy or planning on getting pregnant during the next year

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

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

São Paulo, São Paulo, 05716-150, Brazil

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Linamara Rizzo Battistella, MD PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2014
• First Posted: March 30, 2015
• Study Start: December 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: April 1, 2016
• Last Updated: January 11, 2016

Record last verified: 2016-01

Locations

BR (1)