Field Implementation of iDETECT

Emory University

Status: Completed

Conditions: Concussion; Brain Trauma

Treatments: Device: Riddell High Impact Technology (HIT) System; Device: i1 Biometrics Vector Mouth Guard; Device: integrated Display Enhanced Testing for Cognitive Impairment and mild traumatic brain injury (iDETECT)

Study type: Observational

Funder types: Other

Identifiers

NCT02529618

IRB00082102

Details and patient eligibility

About

The purpose of this study is to assess a new screening tool for sideline evaluation of concussion injuries in athletes. iDETECT is a new technology that combines several elements of recommended concussion screening tools into a single, portable device.

Full description

The goal of the research is to evaluate the use of a multimodal platform (iDETECT) for immediate post-injury neuropsychological, balance and oculomotor assessment, and to evaluate the iDETECT platform as a return-to-play assessment tool during the post injury management period following concussion.

Enrollment: 124 patients

Sex: All

Ages: 14+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Athletes participating in the Fall 2015 high school season
• Aged 14 years or older
• No concussion injuries within prior 2 months
• Provide signed and data consent and/or assent form(s)

Exclusion criteria

• Non-English speaking
• History of seizures or prior brain surgery (excluding facial and TM surgery)
• Concussion within last 2 months
• Poor Effort on baseline iDETECT test

Non-Collision Sport Group

• current concussion or history of current concussion during the Fall 2015 athletic season

Trial design

124 participants in 2 patient groups

Football Athlete Group

Description:

All football athlete participants in this arm will take the integrated Display Enhanced Testing for Cognitive Impairment and mild traumatic brain injury (iDETECT) test. Participants who sustain a concussion during the football season will complete the iDETECT test and a standing balance test (BESS assessment) four times after injury. Participants in this arm are eligible to receive the Riddell High Impact Technology (HIT) System or the i1 Biometrics Vector Mouth Guard. NOTE: Football athletes who sustain a concussion during the football season will be evaluated and managed according to standard concussion screening and return-to-play (RTP) protocols. Performance on iDETECT or other study related tasks will NOT be used to make diagnosis, management, or return to play decisions. Study staff will not assist with or influence diagnosis, management, or return-to-play decision making by teams' medical personnel.

Treatment:

Device: Riddell High Impact Technology (HIT) System

Device: i1 Biometrics Vector Mouth Guard

Device: integrated Display Enhanced Testing for Cognitive Impairment and mild traumatic brain injury (iDETECT)

Non-Collision Sport Athlete Group

Description:

Non-collision sport athletes who are active in a school's Fall athletic program will be take the integrated Display Enhanced Testing for Cognitive Impairment and mild traumatic brain injury (iDETECT) test, standing balance test (BESS assessment), and complete a questionnaire at the beginning of the sport season. Participants will be asked to take the iDETCT test up to 5 more times during the season. Participants who sustain a concussion during the athletic season will be asked to take additional iDETECT tests four times after the injury. NOTE: Non-collision sport athletes who sustain a concussion during the season will be evaluated and managed according to standard concussion screening and return-to-play (RTP) protocols. Performance on iDETECT or other study related tasks will NOT be used to make diagnosis, management, or return to play decisions. Study staff will not assist with or influence diagnosis, management, or return-to-play decision making by teams' medical personnel.

Treatment:

Device: integrated Display Enhanced Testing for Cognitive Impairment and mild traumatic brain injury (iDETECT)