Clinical trial NCT01923441: 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.
Official title: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Minor Traumatic Brain Injury (TBI)
Lead sponsor: ElMindA Ltd
Sponsor class: INDUSTRY
Collaborators: name: Athletico Physical Therapy
First posted: 2013-08-15
Enrollment: 18
Sex: ALL
Minimum age (years): 10
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Up to 300 athletes from Nazareth Academy, Deerfield High School and the Deerfield young warriors program athletes, from both genders, aged 10-19 years

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Changes in BNA™ measures during the sport season in both concussed and non concussed athletes compared to pre season BNA™ baseline measures.
timeFrame: 1 year
measure: 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.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: LaGrange park
country: United States
facility: Athletico N. LaGrange Rd
state: Illinois
Study officials:
affiliation: Athletico Physical Therapy
name: Mike Palm, MS,MBA
role: PRINCIPAL_INVESTIGATOR
References: