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

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.

Completed

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Key information

Conditions

Minor Traumatic Brain Injury (TBI) Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Head Injuries, Closed Nervous System Diseases Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

17 year–24 year

Sex eligibility

All sexes

Study type

Observational

Primary location

York University

Toronto, Ontario, M3J 1P3, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

ElMindA Ltd

Industry

Collaborators

York University

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2014
First posted: Jan 3, 2013
Registry last updated: Apr 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed