Field Implementation of iDETECT

NCT02529618 | Completed

• 1 other identifier: IRB00082102
• Study Type: observational
• Target: 124
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Concussion; Brain Trauma

Outcome Measures

Primary Outcomes (6)

• Area under the curve (AUC) for iDetect total score of neuropsychological assessment (NP) compared to the trainer's determination of clinical concussion

  The area under the receiver operator characteristic (ROC) curve (the concordance index) for total score of NP will be computed and compared with the trainer's determination of clinical concussion to find out if iDETECT is as accurate in diagnosing concussion.

  Baseline, throughout duration of sport season (an expected average of 4 months)

• Area under the curve (AUC) for iDetect NP total score compared to the Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) score

  The area under the receiver operator characteristic (ROC) curve (the concordance index) for total score of NP will be computed and compared to the ImPACT score to find out if iDETECT is as accurate in diagnosing concussion.

  Baseline, throughout duration of sport season (an expected average of 4 months)

• Area under the curve (AUC) for iDetect NP response time to stimuli compared to the trainer's determination of clinical concussion

  The area under the receiver operator characteristic (ROC) curve (the concordance index) for NP response will be computed and compared trainer's determination of clinical concussion to find out if iDETECT is as accurate in diagnosing concussion.

  Baseline, throughout duration of sport season (an expected average of 4 months)

• Area under the curve (AUC) for iDetect NP response time to stimuli compared to Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) score

  The area under the receiver operator characteristic (ROC) curve (the concordance index) for NP response will be computed and compared the ImPACT score to find out if iDETECT is as accurate in diagnosing concussion.

  Baseline, throughout duration of sport season (an expected average of 4 months)

• Area under the curve (AUC) for iDETECT total score compared to final clinical determination of concussion

  The area under the receiver operator characteristic (ROC) curve (the concordance index) for iDETECT total score will be compared to the trainer's final clinical determination of concussion.

  Baseline, throughout duration of sport season (an expected average of 4 months)

• Area under the curve (AUC) for iDETECT total score compared to the Sport Concussion Assessment Tool (SCAT3)

  The area under the receiver operator characteristic (ROC) curve (the concordance index) for iDETECT total score will be compared to the SCAT 3 score. SCAT3 is a standardized tool for evaluating injured athletes for concussion.

  Baseline, throughout duration of sport season (an expected average of 4 months)

Secondary Outcomes (23)

• Area under the curve (AUC) for iDETECT Non-postural Balance/Sensory Integration (SI) battery time to balance compared to trainer's determination of clinical concussion

  Baseline, throughout duration of sport season (an expected average of 4 months)

• Area under the curve (AUC) for iDETECT Non-postural Balance/Sensory Integration (SI) battery time to balance compared to Balance Error Scoring System (BESS) score

  Baseline, throughout duration of sport season (an expected average of 4 months)

• Area under the curve (AUC) for iDETECT Non-postural Balance/Sensory Integration (SI) battery number of overshoots compared to BESS score

  Baseline, throughout duration of sport season (an expected average of 4 months)

• Area under the curve (AUC) for iDETECT Vestibular and Oculomotor (VO) battery angle difference in target motion prediction compared to trainer's determination of clinical concussion

  Baseline, throughout duration of sport season (an expected average of 4 months)

• Area under the curve (AUC) for iDETECT Vestibular and Oculomotor (VO) battery angle difference in target motion prediction compared to King-Devick score (time and number of errors)

  Baseline, throughout duration of sport season (an expected average of 4 months)

Study Arms (2)

Football Athlete Group

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.

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

Non-Collision Sport Athlete Group

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.

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

Interventions

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

iDETECT offers an open platform for an evaluation of cognitive, balance, and oculomotor performance after mild traumatic brain injury (mTBI). It is a rugged, portable, neurocognitive assessment tool designed specifically for use in field and triage settings for the rapid evaluation of functional neurologic impairment after potential concussive injury.

Football Athlete Group; Non-Collision Sport Athlete Group

Riddell High Impact Technology (HIT) System DEVICE

The Riddell HIT system incorporates six acceleration sensors into standard football helmets worn during practice and game play. A computerized sideline system captures information on linear and rotational acceleration, as well as magnitude, duration, and location of impact for each player

Football Athlete Group

i1 Biometrics Vector Mouth Guard DEVICE

The i1 Biometrics Vector Mouth Guard is an impact intelligence system that contains a collection of impact sensing mouth guards, housing accelerometer and gyroscope technology that allows real-time collection and storage of biomechanical impact data. Sensors in the mouth guard communicate directly with a sideline assessment base station and allows for immediate assessment and evaluation of hit exposure.

Football Athlete Group

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

iDETECT will be used to assess neuro-functional outcomes known to be impaired after mTBI in competitive high school athletic teams over a standard season. Eligible participants include: a) all football athletes at participating high schools; b) all non-football athletes who sustain a concussion during the Fall 2015 season; c) interested non-collision sport athletes without a concussion (to serve at controls).

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• National Football League: collaborator

Study Sites (4)

Westminster High School

Atlanta, Georgia, 30327, United States

Location

Woodward Academy

College Park, Georgia, 30337, United States

Location

Marietta High School

Marietta, Georgia, 30064, United States

Location

Blessed Trinity Catholic High School

Roswell, Georgia, 30075, United States

Location

MeSH Terms

Conditions

Brain Concussion; Brain Injuries, Traumatic

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Tamara Espinoza, MD, MPH

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 19, 2015
• First Posted: August 20, 2015
• Study Start: August 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: March 4, 2016

Record last verified: 2016-03

Locations

US (4)