Test-Retest Reliability in DETECT

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Tamara Espinoza, MD, Emory University
ClinicalTrials.gov Identifier:
NCT01733641
First received: November 21, 2012
Last updated: May 23, 2014
Last verified: May 2014
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01733641

Locations
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
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: May 23, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 30, 2014