Investigator Initiated Protocol for the: Evaluation of the Effectiveness and Clinical Utility of Brain Network Activation (BNA™) Technology in the Management of Sport Related Concussion and the Establishment of Normative Data in Youth and Adolescents Athletes
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|ClinicalTrials.gov Identifier: NCT02105935|
Recruitment Status : Completed
First Posted : April 7, 2014
Last Update Posted : July 22, 2020
This study's objectives are:
- To prospectively examine changes in brain network activation (BNA™) from baseline to recovery (i.e., return to activity) in youth and adolescent athletes with concussion.
- To assess the clinical utility of changes in BNA to assist in clinical decision-making.
- To generate normative BNA data.
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||200 participants|
|Official Title:||Investigator Initiated Protocol for the: Evaluation of the Effectiveness and Clinical Utility of Brain Network Activation (BNA™) Technology in the Management of Sport Related Concussion and the Establishment of Normative Data in Youth and Adolescents Athletes.|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||June 2018|
|Actual Study Completion Date :||June 2018|
male and female athletes, ages 8-14.
male and female athletes, ages 8-18.
- quantitative and qualitative analysis of brain network activation (BNA) in participants that have sustained concussion compared to their baseline test. [ Time Frame: 1 year ]quantitative and qualitative analysis of brain network activation (BNA) in participants that have sustained concussion compared to their baseline test.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02105935
|United States, Ohio|
|Cincinnati children's hospital Sport center|
|Cincinnati, Ohio, United States, 45229-3039|
|Principal Investigator:||Gregory Myer, PhD||Children's Hospital Medical Center, Cincinnati|