Navigated Transcranial Magnetic Stimulation in Monitoring Stroke Recovery

Terminated

• Conditions: Ischemic Stroke
• Interventions: Device: Navigated TMS examination

• Registration Number: NCT01005394
• Lead Sponsor: Nexstim Ltd

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-30
• Study First Submitted QC: 2009-10-30
• Study First Posted: 2009-11-01
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-15
• Last Update Posted: 2015-04-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Navigated TMS	Navigated TMS examination	single arm study where all subjects will be studied using the Navigated TMS device

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Safety of navigated transcranial magnetic stimulation examination	each examination

Trial Locations

Locations (1)

Drake Rehabilitation Center; 🇺🇸 Cincinnati, Ohio, United States