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

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ClinicalTrials.gov Identifier: NCT01759173
Recruitment Status : Completed
First Posted : January 3, 2013
Last Update Posted : April 9, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease
Minor Traumatic Brain Injury (TBI)

Study Design

Study Type : Observational
Actual Enrollment : 234 participants
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
Study Start Date : September 2012
Primary Completion Date : August 2014
Study Completion Date : December 2014
Groups and Cohorts

Group/Cohort
college athletes


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
  2. Correlation of the BNA measures in both concussed and non concussed athletes to the clinical diagnosis. [ Time Frame: an average of 1 year ]
  3. To assess the clinical utility of changes in BNA in assisting with clinical decision-making. [ Time Frame: an average of 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

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): NCT01759173


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

Responsible Party: ElMindA Ltd
ClinicalTrials.gov Identifier: NCT01759173     History of Changes
Other Study ID Numbers: ELM-18
First Posted: January 3, 2013    Key Record Dates
Last Update Posted: April 9, 2015
Last Verified: April 2015

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

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