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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01759173

Enrollment

234

Registered

2013-01-03

Start date

2012-09-30

Completion date

2014-12-31

Last updated

2015-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Minor Traumatic Brain Injury (TBI)

Keywords

Minor traumatic brain injury (TBI), Concussion

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

17 Years to 24 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Countries

Canada

Outcome results