Navigated Transcranial Magnetic Stimulation in Monitoring Stroke Recovery

Study Overview
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Brief Summary
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The past 10 years of research in persons more than 6 months post stroke have shown certain types of rehabilitation can help re-wire the brain. Transcranial magnetic stimulation (TMS) can be used to monitor this re-wiring 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 brain activity during the first 6 months after stroke (to determine how the brain re-wires); 2) compare changes in recovery of motor function with changes in brain re-wiring; 3) determine the ability of TMS to predict functional outcome in the first 6 months after stroke. The primary hypotheses are: 1) functional recovery will be correlated with TMS changes (as measure motor threshold (MT), motor evoked potentials (MEPs) and recruitment curves; 2) baseline TMS will predict future functional outcomes at 3 and 6 months.

Official Title
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Acute Longitudinal Transcranial Magnetic Stimulation (TMS) After Stroke

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Device: Navigated TMS examination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: one sided ischemic stroke confirmed by radiology 20-80 years old Exclusion Criteria: hemorrhagic stroke brainstem stroke cerebellar stroke thalamic stroke seizure with the recent stroke any history of uncontrolled seizure history of epilepsy pregnancy or planning on getting pregnant during the next year MRI incompatibility (e.g. metal implants in body) 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Navigated TMS<br>single arm study where all subjects will be studied using the Navigated TMS device | Device: Navigated TMS examination<br>* diagnostic examination using a single pulse TMS paradigm to evaluate corticospinal motor tract integrity and its evolution after stroke<br>* Other names: device: eXimia NBS system;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| navigated transcranial magnetic stimulation examination and correlation with motor functional testing |  | Enrollment, week 2, week 4 , week 12 and week 24 post-stroke | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of navigated transcranial magnetic stimulation examination |  | each examination |