Evaluate the Effectiveness of Brain Network Activation (BNA™) Technology in the Management of Sport Related Concussion

Minor Traumatic Brain Injury (TBI) Clinical Trial

Official title:

Evaluate the Effectiveness of Brain Network Activation (BNA™) Technology in the Management of Sport Related Concussion in the College Age Athletes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01759173
• Other study ID #: ELM-18
• Status: Completed
• Phase: N/A
• First received: December 3, 2012
• Last updated: April 8, 2015
• Start date: September 2012
• Est. completion date: December 2014

Study information

• Verified date: April 2015
• Source: ElMindA Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada:Tri-Council Research Ethics Guidelines
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: December 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 17 Years to 24 Years

Eligibility

Inclusion Criteria:

• Age 17-24, both genders, enrolled in a recognized college and members of a sport team of their school.

Exclusion Criteria:

Current or history of any of the following:

• TBI (i.e., Glasgow Coma Scale <13) or brain surgery

• Any psychiatric disorder

• Any Neurological disorder

• Substance abuse

• Special education

• Any medication affecting CNS

• Significant sensory deficits such as deafness or blindness

• Residual symptoms or deficits related to a previous concussion

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Injuries
• Minor Traumatic Brain Injury (TBI)

Locations

Country	Name	City	State
Canada	York University	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
ElMindA Ltd	York University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in BNA™ measures during the sport season in both concussed and non concussed athletes compared to pre season BNA™ baseline measures.		an average of 1 year	No
Primary	Correlation of the BNA measures in both concussed and non concussed athletes to the clinical diagnosis.		an average of 1 year	No
Primary	To assess the clinical utility of changes in BNA in assisting with clinical decision-making.		an average of 1 year	No