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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

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. ]
Change History
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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