Test-Retest Reliability in DETECT | NCT01733641

Studies
Test-Retest Reliability in DETECT

NCT01733641

Sponsor

Emory University

Status

Terminated

Last Update Posted

Dec 12, 2014Estimated

Enrollment

44Actual

Phase

Not provided

Conditions

Reliability Properties of a Concussion Screening Tool

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Limited eligible sample size for study outcomes

Expanded Access Info

Start Date

Sep 2011

Primary Completion Date

Apr 2013Actual

Completion Date

Apr 2013Actual

First Submitted Date

Nov 21, 2012

First Submission Date that Met QC Criteria

Nov 21, 2012

First Posted Date

Nov 27, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 10, 2014

Last Update Posted Date

Dec 12, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

44Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Healthy volunteer athletes without concussion

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Emory University		Atlanta	Georgia	30322	United States