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Test-Retest Reliability in DETECT

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ClinicalTrials.gov Identifier: NCT01733641
Recruitment Status : Terminated (Limited eligible sample size for study outcomes)
First Posted : November 27, 2012
Last Update Posted : December 12, 2014
Sponsor:
Information provided by (Responsible Party):
Tamara Espinoza, MD, Emory University

Study Description
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Brief Summary:
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.

Condition or disease
Reliability Properties of a Concussion Screening Tool

Study Design
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Study Type : Observational
Actual Enrollment : 44 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Test-Retest Psychometrics of a Novel Neuropsychological Assessment Tool: Reliability Measures for DETECT
Study Start Date : September 2011
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Primary Objective is to assess the reliability of the DETECT cognitive assessment tool, as measured by changes in DETECT scores from baseline in non-injured athletes. [ Time Frame: 90 days ]
    Subjects will complete the DETECT cognitive assessment tool at Baseline, 50 days, and 90 days.


Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy volunteer athletes without concussion
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01733641


Locations
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United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
More Information
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Responsible Party: Tamara Espinoza, MD, Instructor, Emory University
ClinicalTrials.gov Identifier: NCT01733641    
Other Study ID Numbers: IRB00052187
First Posted: November 27, 2012    Key Record Dates
Last Update Posted: December 12, 2014
Last Verified: December 2014