Navigated Transcranial Magnetic Stimulation in Monitoring Stroke Recovery

NCT ID: NCT01005394

Last Updated: 2015-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-10-31

Study Completion Date

2014-03-31

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.

Detailed Description

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Conditions

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Ischemic Stroke

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Navigated TMS

single arm study where all subjects will be studied using the Navigated TMS device

Navigated TMS examination

Intervention Type DEVICE

diagnostic examination using a single pulse TMS paradigm to evaluate corticospinal motor tract integrity and its evolution after stroke

Interventions

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Navigated TMS examination

diagnostic examination using a single pulse TMS paradigm to evaluate corticospinal motor tract integrity and its evolution after stroke

Intervention Type DEVICE

Other Intervention Names

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device: eXimia NBS system

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nexstim Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kari Dunning, PhD,PT

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Locations

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Drake Rehabilitation Center

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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DR-NE-002

Identifier Type: -

Identifier Source: org_study_id

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