Clinical Trials Directory

Trials / Completed

CompletedNCT01923441

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.

Status
Completed
Phase
Study type
Observational
Enrollment
18 (actual)
Sponsor
ElMindA Ltd · Industry
Sex
All
Age
10 Years – 19 Years
Healthy volunteers
Accepted

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

Timeline

Start date
2013-08-01
Primary completion
2014-06-01
Completion
2014-07-01
First posted
2013-08-15
Last updated
2015-04-09

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01923441. Inclusion in this directory is not an endorsement.