Clinical trial NCT02401698: Exploring Cerebellar Inhibition of the Motor Cortex in Stroke Patients
Official title: Exploring Cerebellar Inhibition of the Motor Cortex in Stroke Patients
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Stroke
Keywords: Stroke
Transcranial Magnetic Stimulation
Neuronal Plasticity
Rehabilitation
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2015-03-30
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.

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.

Primary outcomes:
measure: Motor function on the Upper Limb Fugl-Meyer Scale and the motor evoked potentials (MEP) on the Transcranial Magnetic Stimulation.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Centro de Pesquisa Clínica do Instituto de Medicina e Reabilitação do HCFMUSP
Study officials:
affiliation: University of Sao Paulo
name: Linamara Rizzo Battistella, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: