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.

NCT01923441 | Completed

• 1 other identifier: ELM-21
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Minor Traumatic Brain Injury (TBI)

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Highschool athletes

midschool athletes

Eligibility Criteria

• Age: 10 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• ElMindA Ltd: lead
• Athletico Physical Therapy: collaborator

Study Sites (1)

Athletico N. LaGrange Rd

La Grange Park, Illinois, 60526, United States

Location

Study Officials

• Mike Palm, MS,MBA

  Athletico Physical Therapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2013
• First Posted: August 15, 2013
• Study Start: August 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: July 1, 2014
• Last Updated: April 9, 2015

Record last verified: 2013-08

Locations

US (1)