Evaluation of the Effectiveness and Clinical Utility of Brain Network Activation (BNA™) Technology in the Management of Sport Related Concussion in Youth and Adolescents Athletes.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01923441

Enrollment

Registered

2013-08-15

Start date

2013-08-31

Completion date

2014-07-31

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)

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

10 Years to 19 Years

Healthy volunteers

Yes

Inclusion criteria

* Athletes Ages 10-19, both genders, enrolled in Nazareth Academy , Deerfield High School or the Deerfield young warriors youth Football program .

Exclusion criteria

* Self-reported history of central nervous system injury or disease (examples will include, but will not be limited to, moderate or severe traumatic brain injury (TBI with a Glasgow Coma Scale \< 13), epilepsy, seizures, brain surgery, or any positive neuroimaging results) * Active head lice infection, open scalp wound * deafness, and/or blindness * Sustained a concussion within six months * Residual symptoms or deficits related to a previous concussion * Long and thick hair that prevents the proper administration of an EEG cap.

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.	1 year
Correlation of the BNA measures during the sport season in both concussed and non concussed athletes to the clinical diagnosis, symptom scores and the ImPACT test results.	1 year

Countries

United States

Outcome results