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Navigated Transcranial Magnetic Stimulation in Monitoring Stroke Recovery

This study has been terminated.
(Insufficient recruitment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01005394
First Posted: November 2, 2009
Last Update Posted: April 16, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nexstim Ltd
  Purpose

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 Intervention
Ischemic Stroke Device: Navigated TMS examination

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Acute Longitudinal Transcranial Magnetic Stimulation (TMS) After Stroke

Further study details as provided by Nexstim Ltd:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Safety of navigated transcranial magnetic stimulation examination [ Time Frame: each examination ]

Enrollment: 5
Study Start Date: October 2009
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: device: eXimia NBS system

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01005394


Locations
United States, Ohio
Drake Rehabilitation Center
Cincinnati, Ohio, United States, 45216
Sponsors and Collaborators
Nexstim Ltd
Investigators
Principal Investigator: Kari Dunning, PhD,PT University of Cincinnati
  More Information

Responsible Party: Nexstim Ltd
ClinicalTrials.gov Identifier: NCT01005394     History of Changes
Other Study ID Numbers: DR-NE-002
First Submitted: October 30, 2009
First Posted: November 2, 2009
Last Update Posted: April 16, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases