An Investigator Initiated Study to Evaluate the Effectiveness of Brain Network Activation (BNA™) Technology in the Management of Sport Related Concussion

NCT01963247 | Completed

• 1 other identifier: ELM-22
• Study Type: observational
• Target: 145
• 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. The BNA test is basically divided to 3 phases - first EEG data is collected from subjects using an EEG system while the subject is performing a cognitive task in front of a computer. The EEG data is then analyzed using the advanced BNA™ technology. Finally, a report of the BNA™ test is generated.

Conditions

Healthy; Minor Traumatic Brain Injury (TBI)

Outcome Measures

Primary Outcomes (2)

• changes in BNA™ measures during the sport season

  Consistency or changes in BNA™ measures during and after 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 concussed athletes to the clinical diagnosis, symptom scores and the ImPACT test results.

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

  1 year

Study Arms (2)

Healthy Athletes

Concussed Athletes

Eligibility Criteria

• Age: 11 Years - 15 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

150 male athletes enrolled in Minnesota Youth Hockey Programs, aged 11-15 years.

You may qualify if:

• Male athletes
• aged 11-15
• enrolled in selected Minnesota Youth Hockey Programs

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
• A concussion within prior 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
• Noran Neurological Clinic: collaborator

Study Sites (1)

Noran Neurological Clinic

Minneapolis, Minnesota, 55407, United States

Location

Study Officials

• Steven s Lebow, MD

  Noran Neurological Clinic

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 10, 2013
• First Posted: October 16, 2013
• Study Start: October 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 9, 2015

Record last verified: 2015-04

Locations

US (1)