Clinical trial NCT01759173: Evaluate the Effectiveness of Brain Network Activation (BNA™) Technology in the Management of Sport Related Concussion
Official title: Evaluate the Effectiveness of Brain Network Activation (BNA™) Technology in the Management of Sport Related Concussion in the College Age Athletes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Minor Traumatic Brain Injury (TBI)
Keywords: Minor traumatic brain injury (TBI)
Concussion
Lead sponsor: ElMindA Ltd
Sponsor class: INDUSTRY
Collaborators: name: York University
First posted: 2013-01-03
Enrollment: 234
Sex: ALL
Minimum age (years): 17
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 200-300 athletes from 3-9 college sport teams, from both genders, aged 17-24 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:

* 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

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: an average of 1 year
measure: Correlation of the BNA measures in both concussed and non concussed athletes to the clinical diagnosis.
timeFrame: an average of 1 year
measure: To assess the clinical utility of changes in BNA in assisting with clinical decision-making.
timeFrame: an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: York University
state: Ontario
Study officials:
affiliation: York University
name: Mazyar Fallah, PhD
role: PRINCIPAL_INVESTIGATOR
References: