Test-Retest Reliability in DETECT

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

Tracking Information

• First Submitted Date: November 21, 2012
• First Posted Date: November 27, 2012
• Last Update Posted Date: December 12, 2014
• Study Start Date: September 2011
• Actual Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 26, 2012)

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.

• Original Primary Outcome Measures (submitted: November 21, 2012): 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: Baseline, day 50 , and day 90. ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Test-Retest Reliability in DETECT
• Official Title: Test-Retest Psychometrics of a Novel Neuropsychological Assessment Tool: Reliability Measures for DETECT
• 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.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Healthy volunteer athletes without concussion
• Condition: Reliability Properties of a Concussion Screening Tool
• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: December 10, 2014): 44
• Original Estimated Enrollment (submitted: November 21, 2012): 100
• Actual Study Completion Date: April 2013
• Actual Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)

Eligibility 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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 16 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01733641
• Other Study ID Numbers: IRB00052187
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Tamara Espinoza, MD, Emory University
• Study Sponsor: Emory University
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Emory University
• Verification Date: December 2014