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An Investigator Initiated Study to Evaluate the Effectiveness of Brain Network Activation (BNA™) Technology in the Management of Sport Related Concussion

NCT01963247 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 145

Last updated 2015-04-09

No results posted yet for this study

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.

The BNA test is basically divided to 3 phases - first EEG data is collected from subjects using an EEG system while the subject is performing a cognitive task in front of a computer. The EEG data is then analyzed using the advanced BNA™ technology. Finally, a report of the BNA™ test is generated.

Conditions

  • Healthy
  • Minor Traumatic Brain Injury (TBI)

Sponsors & Collaborators

  • Noran Neurological Clinic

    collaborator UNKNOWN

  • ElMindA Ltd

    lead INDUSTRY

Principal Investigators

  • Steven s Lebow, MD · Noran Neurological Clinic

Eligibility

Min Age
11 Years
Max Age
15 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2014-08-31
Completion
2014-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01963247 on ClinicalTrials.gov