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Evaluate the Effectiveness of Brain Network Activation (BNA™) Technology in the Management of Sport Related Concussion

This study is currently recruiting participants.
Verified December 2012 by ElMindA Ltd
Sponsor:
Collaborator:
York University
Information provided by (Responsible Party):
ElMindA Ltd
ClinicalTrials.gov Identifier:
NCT01759173
First received: December 3, 2012
Last updated: December 27, 2012
Last verified: December 2012
History of Changes
  Purpose

Currently, there is no direct, reliable, bed-side, and non-invasive method for assessing changes in brain activity associated with concussion. Event Related Potentials (ERPs), which are temporal reflections of the neural mass electrical activity of cells in specific regions of the brain that occur in response to stimuli, may offer such a method, as they provide both a noninvasive and portable measure of brain function. The ERPs provide excellent temporal information, but spatial resolution for ERPs has traditionally been limited. However, by using high-density electroencephalograph (EEG) recording spatial resolution for ERPs is improved significantly. The paradigm for the current study will combine neurophysiological knowledge with mathematical signal processing and pattern recognition methods (BNA™) to temporally and spatially map brain function, connectivity and synchronization.

The proposed study will provide additional evidence for the utility and contribution of the BNA™ test (reflecting temporal and spatial changes in brain activity as well as brain functional connectivity associated with concussion) in concussion management.


Condition
Minor Traumatic Brain Injury (TBI)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluate the Effectiveness of Brain Network Activation (BNA™) Technology in the Management of Sport Related Concussion in the College Age Athletes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by ElMindA Ltd:

Primary Outcome Measures:
  • Changes in BNA™ measures during the sport season in both concussed and non concussed athletes compared to pre season BNA™ baseline measures. [ Time Frame: an average of 1 year ] [ Designated as safety issue: No ]
  • Correlation of the BNA measures in both concussed and non concussed athletes to the clinical diagnosis. [ Time Frame: an average of 1 year ] [ Designated as safety issue: No ]
  • To assess the clinical utility of changes in BNA in assisting with clinical decision-making. [ Time Frame: an average of 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: August 2012
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
college athletes

  Eligibility

Ages Eligible for Study:   17 Years to 24 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

200-300 athletes from 3-9 college sport teams, from both genders, aged 17-24 years.

Criteria

Inclusion Criteria:

  • Age 17-24, both genders, enrolled in a recognized college and members of a sport team of their school.

Exclusion Criteria:

Current or history of any of the following:

  • TBI (i.e., Glasgow Coma Scale <13) or brain surgery
  • Any psychiatric disorder
  • Any Neurological disorder
  • Substance abuse
  • Special education
  • Any medication affecting CNS
  • Significant sensory deficits such as deafness or blindness
  • Residual symptoms or deficits related to a previous concussion
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01759173

Contacts
Contact: Mazyar Fallah, PhD mfallah@yorku.ca

Locations
Canada, Ontario
York University Recruiting
Toronto, Ontario, Canada, M3J 1P3
Contact: Mazyar Fallah, PhD            
Sponsors and Collaborators
ElMindA Ltd
York University
Investigators
Principal Investigator: Mazyar Fallah, PhD York University
  More Information

No publications provided

Responsible Party: ElMindA Ltd
ClinicalTrials.gov Identifier: NCT01759173     History of Changes
Other Study ID Numbers: ELM-18
Study First Received: December 3, 2012
Last Updated: December 27, 2012
Health Authority: Canada:Tri-Council Research Ethics Guidelines

Keywords provided by ElMindA Ltd:
Minor traumatic brain injury (TBI)
Concussion

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on May 23, 2013