Field Implementation of iDETECT

Concussion Clinical Trial

Official title:

Implementation of iDETECT for Field Triage of mTBI in Football Players

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02529618
• Other study ID #: IRB00082102
• Status: Completed
• Phase: N/A
• First received: August 19, 2015
• Last updated: March 3, 2016
• Start date: August 2015
• Est. completion date: February 2016

Study information

• Verified date: March 2016
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 14 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Trauma
• Concussion

Intervention

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

Locations

Country	Name	City	State
United States	Westminster High School	Atlanta	Georgia
United States	Woodward Academy	College Park	Georgia
United States	Marietta High School	Marietta	Georgia
United States	Blessed Trinity Catholic High School	Roswell	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Football League

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Secondary	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	The area under the receiver operator characteristic (ROC) curve (the concordance index) for SI battery time will be computed and compared to 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)	No
Secondary	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	The area under the receiver operator characteristic (ROC) curve (the concordance index) for SI battery time will be computed and compared to BESS score to find out if iDETECT is as accurate in diagnosing concussion.The SI battery requires participants to utilize primary sensory inputs to assess the state of a virtual balance beam displayed within the iDETECT visor immersive environment without standing.	Baseline, throughout duration of sport season (an expected average of 4 months)	No
Secondary	Area under the curve (AUC) for iDETECT Non-postural Balance/Sensory Integration (SI) battery number of overshoots compared to BESS score	The area under the receiver operator characteristic (ROC) curve (the concordance index) for SI battery number of overshoots will be computed and compared to the BESS score to find out if iDETECT is as accurate in diagnosing concussion.	Baseline, throughout duration of sport season (an expected average of 4 months)	No
Secondary	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	The area under the receiver operator characteristic (ROC) curve (the concordance index) for VO battery angle distance in target motion prediction will be computed and compared to 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)	No
Secondary	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)	The area under the receiver operator characteristic (ROC) curve (the concordance index) will be computed and compared to the King-Devick score (time and number of errors).	Baseline, throughout duration of sport season (an expected average of 4 months)	No
Secondary	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	The area under the receiver operator characteristic (ROC) curve (the concordance index) for VO battery angle difference in target motion interference will be computed and compared to 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)	No
Secondary	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)	The area under the receiver operator characteristic (ROC) curve (the concordance index) for VO battery angle difference in target motion interference will be computed and compared to the to King-Devick score (time and number of errors) to find out if iDETECT is as accurate in diagnosing concussion.	Baseline, throughout duration of sport season (an expected average of 4 months)	No
Secondary	Change in iDETECT total score from baseline to time of injury	Difference in iDETECT total score from baseline to time of concussion will be used to calculate the degree of discrimination in concussed athletes.	Baseline, time of concussion	No
Secondary	Change in iDETECT total score from baseline to end of season to assess subconcussion	Mean scores between cases and controls will be compared on iDETECT. Change is defined as the difference in scores from baseline to the end of the season.	Baseline, end of sport season (an expected average of 4 months)	No
Secondary	Change in Sport Concussion Assessment Tool 3 (SCAT3) total score from baseline to end of season to assess subconcussion	Mean scores between cases and controls will be compared using the SCAT3. Change is defined as the difference in scores from baseline to the end of the season.	Baseline, end of sport season (an expected average of 4 months)	No
Secondary	iDETECT word recall score post injury	Subjects are asked to remember a group of 12 words displayed one at a time. They are then shown 24 words and asked to respond 'YES' for a word in the original list and 'NO' for a word that was not in the original list. Subjects are scored on the number of words they correctly remember being on the list.	3 days post injury (3 minutes)	No
Secondary	Change in iDETECT mean word recall score post injury, 10 days	Subjects are asked to remember a group of 12 words displayed one at a time. They are then shown 24 words and asked to respond 'YES' for a word in the original list and 'NO' for a word that was not in the original list. Subjects are scored on the number of words they correctly remember being on the list. Change is defined as the difference in scores from 3 days post injury to 10 days post injury.	3 days post injury (3 minutes), 10 days post injury (3 minutes)	No
Secondary	Change in iDETECT mean word recall score post injury, 30 days	Subjects are asked to remember a group of 12 words displayed one at a time. They are then shown 24 words and asked to respond 'YES' for a word in the original list and 'NO' for a word that was not in the original list. Subjects are scored on the number of words they correctly remember being on the list. Change is defined as the difference in scores from 10 days post injury to 30 days post injury.	10 days post injury (3 minutes), 30 days post injury (3 minutes)	No
Secondary	iDETECT shapes test score post injury	Subjects are presented a shape stimulus with 3 characteristics: shape, color, and crosshatch orientation and asked to remember the object. The subject selects the correct shape with 'YES' and each incorrect shape with 'NO'. Score is calculated by correctly selecting the shape.	3 days post injury (2 minutes)	No
Secondary	Change in iDETECT mean shapes test score post injury, 10 days	Subjects are presented a shape stimulus with 3 characteristics: shape, color, and crosshatch orientation and asked to remember the object. The subject selects the correct shape with 'YES' and each incorrect shape with 'NO'. Score is calculated by correctly selecting the shape. Change is defined as the difference in scores from 3 days post injury to 10 days post injury.	3 days post injury (2 minutes), 10 days post injury (2 minutes)	No
Secondary	Change in iDETECT mean shapes test score post injury, 30 days	Subjects are presented a shape stimulus with 3 characteristics: shape, color, and crosshatch orientation and asked to remember the object. The subject selects the correct shape with 'YES' and each incorrect shape with 'NO'. Score is calculated by correctly selecting the shape. Change is defined as the difference in scores from 10 days post injury to 30 days post injury.	10 days post injury (3 minutes), 30 days post injury (3 minutes)	No
Secondary	iDETECT arrows test score post injury	Subjects are asked to respond to an arrow with 2 characteristics: orientation and color. If the arrow is blue, they select the side that the arrow is pointing. If the arrow is red, they select the side opposite from where it is pointing. Score is calculated by the number of correct responses.	3 days post injury (2 minutes)	No
Secondary	Change in iDETECT mean arrows test score post injury, 10 days	Subjects are asked to respond to an arrow with 2 characteristics: orientation and color. If the arrow is blue, they select the side that the arrow is pointing. If the arrow is red, they select the side opposite from where it is pointing. Score is calculated by the number of correct responses. Change is defined as the difference in scores from 3 days post injury to 10 days post injury.	3 days post injury (2 minutes), 10 days post injury (2 minutes)	No
Secondary	Change in iDETECT mean arrows test score post injury, 30 days	Subjects are asked to respond to an arrow with 2 characteristics: orientation and color. If the arrow is blue, they select the side that the arrow is pointing. If the arrow is red, they select the side opposite from where it is pointing. Score is calculated by the number of correct responses. Change is defined as the difference in scores from 10 days post injury to 30 days post injury.	10 days post injury (2 minutes), 30 days post injury (2 minutes)	No
Secondary	iDETECT N-BACK (1-back and 2-back) test post injury	Subjects view a series of faces one at a time and choose if the face has been shown before. The subject selects 'YES' if the face shown is the same as the previous or 'NO' if it is not. Score is calculated by the number of correct responses.	3 days post injury (2 minutes)	No
Secondary	iDETECT Delayed Word Recall Test	Subjects are asked to recite words from the word recall test after a five minute delay. Score is calculated by the number of words correctly recalled.	3 days post injury (2 minutes)	No
Secondary	Change in iDETECT Delayed Word Recall Test	Subjects are asked to recite words from the word recall test after a five minute delay. Score is calculated by the number of words correctly recalled. Change is defined as the difference in scores from 3 days post injury to 10 days post injury.	3 days post injury (2 minutes), 10 days post injury (2 minutes)	No
Secondary	Change in iDETECT Delayed Word Recall Test	Subjects are asked to recite words from the word recall test after a five minute delay. Score is calculated by the number of words correctly recalled. Change is defined as the difference in scores from 10 days post injury to 30 days post injury.	10 days post injury (2 minutes), 30 days post injury (2 minutes)	No