Clinical trial NCT02529618: Field Implementation of iDETECT
Official title: Implementation of iDETECT for Field Triage of mTBI in Football Players
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Concussion
Brain Trauma
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Football League
First posted: 2015-08-20
Enrollment: 124
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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).

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Area under the curve (AUC) for iDetect total score of neuropsychological assessment (NP) compared to the trainer's determination of clinical concussion
timeFrame: Baseline, throughout duration of sport season (an expected average of 4 months)
measure: Area under the curve (AUC) for iDetect NP total score compared to the Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) score
timeFrame: Baseline, throughout duration of sport season (an expected average of 4 months)
measure: Area under the curve (AUC) for iDetect NP response time to stimuli compared to the trainer's determination of clinical concussion
timeFrame: Baseline, throughout duration of sport season (an expected average of 4 months)
measure: Area under the curve (AUC) for iDetect NP response time to stimuli compared to Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) score
timeFrame: Baseline, throughout duration of sport season (an expected average of 4 months)
measure: Area under the curve (AUC) for iDETECT total score compared to final clinical determination of concussion
timeFrame: Baseline, throughout duration of sport season (an expected average of 4 months)
measure: Area under the curve (AUC) for iDETECT total score compared to the Sport Concussion Assessment Tool (SCAT3)
timeFrame: Baseline, throughout duration of sport season (an expected average of 4 months)
Secondary outcomes:
measure: 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
timeFrame: Baseline, throughout duration of sport season (an expected average of 4 months)
measure: 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
timeFrame: Baseline, throughout duration of sport season (an expected average of 4 months)
measure: Area under the curve (AUC) for iDETECT Non-postural Balance/Sensory Integration (SI) battery number of overshoots compared to BESS score
timeFrame: Baseline, throughout duration of sport season (an expected average of 4 months)
measure: 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
timeFrame: Baseline, throughout duration of sport season (an expected average of 4 months)
measure: 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)
timeFrame: Baseline, throughout duration of sport season (an expected average of 4 months)
measure: Area under the curve (AUC) for iDETECT Vestibular and Oculomotor (VO) battery angle difference in target motion interefence compared to trainer's determination of clinical concussion
timeFrame: Baseline, throughout duration of sport season (an expected average of 4 months)
measure: Area under the curve (AUC) for iDETECT Vestibular and Oculomotor (VO) battery angle difference in target motion interefence compared to King-Devick score (time and number of errors)
timeFrame: Baseline, throughout duration of sport season (an expected average of 4 months)
measure: Change in iDETECT total score from baseline to time of injury
timeFrame: Baseline, time of concussion
measure: Change in iDETECT total score from baseline to end of season to assess subconcussion
timeFrame: Baseline, end of sport season (an expected average of 4 months)
measure: Change in Sport Concussion Assessment Tool 3 (SCAT3) total score from baseline to end of season to assess subconcussion
timeFrame: Baseline, end of sport season (an expected average of 4 months)
measure: iDETECT word recall score post injury
timeFrame: 3 days post injury (3 minutes)
measure: Change in iDETECT mean word recall score post injury, 10 days
timeFrame: 3 days post injury (3 minutes), 10 days post injury (3 minutes)
measure: Change in iDETECT mean word recall score post injury, 30 days
timeFrame: 10 days post injury (3 minutes), 30 days post injury (3 minutes)
measure: iDETECT shapes test score post injury
timeFrame: 3 days post injury (2 minutes)
measure: Change in iDETECT mean shapes test score post injury, 10 days
timeFrame: 3 days post injury (2 minutes), 10 days post injury (2 minutes)
measure: Change in iDETECT mean shapes test score post injury, 30 days
timeFrame: 10 days post injury (3 minutes), 30 days post injury (3 minutes)
measure: iDETECT arrows test score post injury
timeFrame: 3 days post injury (2 minutes)
measure: Change in iDETECT mean arrows test score post injury, 10 days
timeFrame: 3 days post injury (2 minutes), 10 days post injury (2 minutes)
measure: Change in iDETECT mean arrows test score post injury, 30 days
timeFrame: 10 days post injury (2 minutes), 30 days post injury (2 minutes)
measure: iDETECT N-BACK (1-back and 2-back) test post injury
timeFrame: 3 days post injury (2 minutes)
measure: iDETECT Delayed Word Recall Test
timeFrame: 3 days post injury (2 minutes)
measure: Change in iDETECT Delayed Word Recall Test
timeFrame: 3 days post injury (2 minutes), 10 days post injury (2 minutes)
measure: Change in iDETECT Delayed Word Recall Test
timeFrame: 10 days post injury (2 minutes), 30 days post injury (2 minutes)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Westminster High School
state: Georgia
city: College Park
country: United States
facility: Woodward Academy
state: Georgia
city: Marietta
country: United States
facility: Marietta High School
state: Georgia
city: Roswell
country: United States
facility: Blessed Trinity Catholic High School
state: Georgia
Study officials:
affiliation: Emory University
name: Tamara Espinoza, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: