Evaluate the Effectiveness of Brain Network Activation (BNA™) Technology in the Management of Sport Related Concussion

NCT ID: NCT01759173

Last Updated: 2015-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

234 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Minor Traumatic Brain Injury (TBI)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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college athletes

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

17 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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York University

OTHER

Sponsor Role collaborator

ElMindA Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mazyar Fallah, PhD

Role: PRINCIPAL_INVESTIGATOR

York University

Locations

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York University

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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ELM-18

Identifier Type: -

Identifier Source: org_study_id

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