Test-Retest Reliability in DETECT

Reliability Properties of a Concussion Screening Tool Clinical Trial

Official title:

Test-Retest Psychometrics of a Novel Neuropsychological Assessment Tool: Reliability Measures for DETECT

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01733641
• Other study ID #: IRB00052187
• Status: Terminated
• Phase: N/A
• First received: November 21, 2012
• Last updated: December 10, 2014
• Start date: September 2011
• Est. completion date: April 2013

Study information

• Verified date: December 2014
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 44
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years and older

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Reliability Properties of a Concussion Screening Tool

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Subjects will complete the DETECT cognitive assessment tool at Baseline, 50 days, and 90 days.	90 days	No