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

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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02105935

Enrollment

200

Registered

2014-04-07

Start date

2014-04-30

Completion date

2018-06-30

Last updated

2020-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Concussed, Normative

Brief summary

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.

Detailed description

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

8 Years to 18 Years

Healthy volunteers

Yes

Inclusion criteria

* • Male and Female Athletes: Age 8-14 (Arm 1) or 8-18 years (Arm 2). * For Arm 1 - Over 3 days and below 7 days post-concussion (sports-related) and currently symptomatic * Able to speak, read and understand English sufficiently to understand the nature of the study, and to allow completion of all study assessments. * Willingness to participate and able to give informed assent (child) and Parental consent

Exclusion criteria

* Currently with lice or open wounds on scalp. * Long and thick hair that prevents the proper administration of an EEG cap. * Significant sensory deficits, e.g., deafness or blindness. * Normative

Design outcomes

Primary

Measure	Time frame	Description
quantitative and qualitative analysis of brain network activation (BNA) in participants that have sustained concussion compared to their baseline test.	1 year	quantitative and qualitative analysis of brain network activation (BNA) in participants that have sustained concussion compared to their baseline test.

Countries

United States

Outcome results