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
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 Type :||Observational|
|Actual Enrollment :||234 participants|
|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|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||December 2014|
- 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 ]
- Correlation of the BNA measures in both concussed and non concussed athletes to the clinical diagnosis. [ Time Frame: an average of 1 year ]
- To assess the clinical utility of changes in BNA in assisting with clinical decision-making. [ Time Frame: an average of 1 year ]
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
|Toronto, Ontario, Canada, M3J 1P3|
|Principal Investigator:||Mazyar Fallah, PhD||York University|