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

Completed

• Conditions: Minor Traumatic Brain Injury (TBI)

• Registration Number: NCT01759173
• Lead Sponsor: ElMindA Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-12-03
• Study First Submitted QC: 2012-12-27
• Study First Posted: 2013-01-03
• Primary Completion: 2014-08
• Study Completion: 2014-12
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-08
• Last Update Posted: 2015-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 234

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in BNA™ measures during the sport season in both concussed and non concussed athletes compared to pre season BNA™ baseline measures.	an average of 1 year
Correlation of the BNA measures in both concussed and non concussed athletes to the clinical diagnosis.	an average of 1 year
To assess the clinical utility of changes in BNA in assisting with clinical decision-making.	an average of 1 year

Trial Locations

Locations (1)

York University; 🇨🇦 Toronto, Ontario, Canada