Comparison of Brain Network Activation (BNA™) Analysis, Clinical Symptoms and Neuro-cognitive Performance in Concussed Children and Young Adults

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

151 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-02-29

Study Completion Date

2014-03-31

Brief Summary

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The use of Event Related Potentials (ERP) and neurocognitive performance in patients following concussion has been examined previously in small cohorts and relatively long after concussion occurred. However, little is known about the immediate changes in brain activity in specific brain regions and connectivity across them associated with performance on specific neurocognitive tests following a concussion, and the subsequent changes over time. The proposed study will provide initial evidence for the feasibility of an ERP based biomarker for concussion reflecting temporal and spatial changes in brain activity as well as brain functional connectivity associated with concussion.

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Detailed Description

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Conditions

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Traumatic Brain Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Concussed

Patients with recent concussion

No interventions assigned to this group

Matched controls

Athletes with no recent concussion

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Aged 14-27 years
* Arm 1 only (Concussed): Over 2 days and below 10 days post-concussion (sports-related)
* Currently symptomatic
* Willingness to participate and able to give informed assent (child) and/or consent (parent for minors or adult 18+ years of age for self)

Exclusion Criteria

* TBI (i.e., Glasgow Coma Scale \<13) or brain surgery
* Any psychiatric disorder
* Substance abuse
* Special education
* Any Neurological disorder
* Any medication affecting CNS
* Significant sensory deficits such as deafness or blindness
* Clinically significant abnormal laboratory values or ECG
* A history of more than 3 concussions in the past
* A concussion within the last year
* Residual symptoms or deficits related to a previous concussion

Minimum Eligible Age

14 Years

Maximum Eligible Age

27 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes