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Test-Retest Reliability in DETECT

NCT ID: NCT01733641

Last Updated: 2014-12-12

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

TERMINATED

Total Enrollment

44 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-04-30

Brief Summary

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Healthy volunteers without concussion, currently participating in non-or-limited contact sports teams at Emory University will undergo Display Enhanced Testing for Concussion and mild traumatic brain injury (mTBI) (DETECT) on three separate days: at baseline, day 50, and day 90. Prior to enrollment participants will be allocated to the test-retest arm or the exercise arm.

Detailed Description

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Conditions

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Reliability Properties of a Concussion Screening Tool

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* age \> or = 16
* eligible for active participation during the National Collegiate Athletic Association (NCAA) season or member of the 2011 - 2012 or 2012-2013 club team
* Participation in a non or minimal contact sport

Exclusion Criteria

* \< age 16
* history of concussion in the previous 6 months
* any of the following: learning disabilities, attention deficient disorder, attention deficit hyperactivity disorder, depression or other psychiatric disorder, sleep apnea, seizure disorder, migraine headaches, previous central nervous system (CNS) surgery
* chronic drug or alcohol use; or drug or alcohol use with the previous 24 hours
* inability to complete the study protocol (90 days)
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Emory University

OTHER

Sponsor Role lead

Responsible Party

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Tamara Espinoza, MD

Instructor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Emory University

Atlanta, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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IRB00052187

Identifier Type: -

Identifier Source: org_study_id