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Navigated Transcranial Magnetic Stimulation in Monitoring Stroke Recovery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Nexstim Ltd.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Nexstim Ltd
ClinicalTrials.gov Identifier:
NCT01005394
First received: October 30, 2009
Last updated: June 7, 2011
Last verified: June 2011
History of Changes
  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

Resource links provided by NLM:

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety of navigated transcranial magnetic stimulation examination [ Time Frame: each examination ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: October 2009
Estimated Primary Completion Date: December 2011 (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

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01005394

Contacts
Contact: Kari Dunning, PhD,PT 513-703-8000 DUNNINKK@UCMAIL.UC.EDU
Contact: Susan Israel, PT 513-418-5991 sei4123@hotmail.com

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

No publications provided

Responsible Party: Jarmo Laine, M.D., Director of Clinical Operations, Nexstim Ltd
ClinicalTrials.gov Identifier: NCT01005394     History of Changes
Other Study ID Numbers: DR-NE-002
Study First Received: October 30, 2009
Last Updated: June 7, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on June 17, 2013