Test-Retest Reliability in DETECT

This study is currently recruiting participants.
Verified November 2013 by Emory University
Sponsor:
Information provided by (Responsible Party):
Tamara Espinoza, MD, Emory University
ClinicalTrials.gov Identifier:
NCT01733641
First received: November 21, 2012
Last updated: November 14, 2013
Last verified: November 2013
  Purpose

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
Reliability Properties of a Concussion Screening Tool

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Test-Retest Psychometrics of a Novel Neuropsychological Assessment Tool: Reliability Measures for DETECT

Further study details as provided by Emory University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Subjects will complete the DETECT cognitive assessment tool at Baseline, 50 days, and 90 days.


Estimated Enrollment: 100
Study Start Date: September 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01733641

Contacts
Contact: Tamara Espinoza, MD tamara.espinoza@emory.edu
Contact: David W Wright, MD dwwrigh@emory.edu

Locations
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Tamara Espinoza, MD       tamara.espinoza@emory.edu   
Sponsors and Collaborators
Emory University
  More Information

No publications provided

Responsible Party: Tamara Espinoza, MD, Instructor, Emory University
ClinicalTrials.gov Identifier: NCT01733641     History of Changes
Other Study ID Numbers: IRB00052187
Study First Received: November 21, 2012
Last Updated: November 14, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on April 20, 2014