Navigated Transcranial Magnetic Stimulation in Monitoring Stroke Recovery

April 15, 2015 updated by: Nexstim Ltd

Acute Longitudinal Transcranial Magnetic Stimulation (TMS) After Stroke

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

5

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45216
        • Drake Rehabilitation Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients aged 20-80 years who have suffered a unilateral ischemic stroke and who will undergo motor rehabilitation at the study center will be asked to participate in the study.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety of navigated transcranial magnetic stimulation examination
Time Frame: each examination
each examination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nexstim Ltd

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

October 30, 2009

First Submitted That Met QC Criteria

October 30, 2009

First Posted (Estimate)

November 1, 2009

Study Record Updates

Last Update Posted (Estimate)

April 16, 2015

Last Update Submitted That Met QC Criteria

April 15, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DR-NE-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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