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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02529618
Other study ID # IRB00082102
Secondary ID
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


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
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