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.

ElMindA

Status: Completed

Conditions: Minor Traumatic Brain Injury (TBI)

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01923441

ELM-21

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 10 to 19 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

18 participants in 2 patient groups

Highschool athletes

midschool athletes