Clincosm LogoSign in Get a demo

Navigated Transcranial Magnetic Stimulation in Monitoring Stroke Recovery

Sponsor
Nexstim Ltd (Industry)
Overall Status
Terminated
CT.gov ID
NCT01005394
Collaborator
(none)
5
Enrollment
1
Location
53
Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Navigated TMS examination

Study Design

Study Type:
Observational
Actual Enrollment :
5 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Acute Longitudinal Transcranial Magnetic Stimulation (TMS) After Stroke
Study Start Date :
Oct 1, 2009
Actual Primary Completion Date :
Mar 1, 2014
Actual Study Completion Date :
Mar 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Navigated TMS

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

Device: Navigated TMS examination
diagnostic examination using a single pulse TMS paradigm to evaluate corticospinal motor tract integrity and its evolution after stroke
Other Names:
  • device: eXimia NBS system

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Safety of navigated transcranial magnetic stimulation examination [each examination]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Drake Rehabilitation Center Cincinnati Ohio United States 45216

    Sponsors and Collaborators

    • Nexstim Ltd

    Investigators

    • Principal Investigator: Kari Dunning, PhD,PT, University of Cincinnati

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nexstim Ltd
    ClinicalTrials.gov Identifier:
    NCT01005394
    Other Study ID Numbers:
    • DR-NE-002
    First Posted:
    Nov 1, 2009
    Last Update Posted:
    Apr 16, 2015
    Last Verified:
    Apr 1, 2015
    Additional relevant MeSH terms:
    Stroke
    Ischemic Stroke

    Study Results

    No Results Posted as of Apr 16, 2015