ConcussionNCT02529618
Field Implementation of iDETECT
An observational study of Concussion and Brain Trauma, run by Emory University at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Concussion, Brain Trauma
- What is being tested?
- integrated Display Enhanced Testing for Cognitive Impairment and mild traumatic brain injury (iDETECT), Riddell High Impact Technology (HIT) System and i1 Biometrics Vector Mouth Guard
- Type of treatment
- Medical device
- How many people
- 124 participants
- Where
- 4 sitesUnited States
- Study dates
- Aug 2015to Feb 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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).
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
4 sites in 1 country.
United States4 sites
Westminster High School
Atlanta, Georgia, 30327
Woodward Academy
College Park, Georgia, 30337
Marietta High School
Marietta, Georgia, 30064
Blessed Trinity Catholic High School
Roswell, Georgia, 30075
About this study
Official title: Implementation of iDETECT for Field Triage of mTBI in Football Players
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.
Read the 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.
- Conditions
- Concussion, Brain Trauma
- Being tested
- integrated Display Enhanced Testing for Cognitive Impairment and mild traumatic brain injury (iDETECT), Riddell High Impact Technology (HIT) System, i1 Biometrics Vector Mouth Guard
- Medical subject headings
- Brain Concussion, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Riddell High Impact Technology (HIT) SystemDevice
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 GuardDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: integrated Display Enhanced Testing for Cognitive Impairment and mild traumatic brain injury (iDETECT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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)
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).
Measured: 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 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.
Measured: 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 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.
Measured: Baseline, throughout duration of sport season (an expected average of 4 months)
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.
Measured: Baseline, time of concussion
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.
Measured: Baseline, end of sport season (an expected average of 4 months)
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.
Measured: Baseline, end of sport season (an expected average of 4 months)
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.
Measured: 3 days post injury (3 minutes)
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.
Measured: 3 days post injury (3 minutes), 10 days post injury (3 minutes)
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.
Measured: 10 days post injury (3 minutes), 30 days post injury (3 minutes)
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.
Measured: 3 days post injury (2 minutes)
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.
Measured: 3 days post injury (2 minutes), 10 days post injury (2 minutes)
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.
Measured: 10 days post injury (3 minutes), 30 days post injury (3 minutes)
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.
Measured: 3 days post injury (2 minutes)
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.
Measured: 3 days post injury (2 minutes), 10 days post injury (2 minutes)
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.
Measured: 10 days post injury (2 minutes), 30 days post injury (2 minutes)
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.
Measured: 3 days post injury (2 minutes)
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.
Measured: 3 days post injury (2 minutes)
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.
Measured: 3 days post injury (2 minutes), 10 days post injury (2 minutes)
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.
Measured: 10 days post injury (2 minutes), 30 days post injury (2 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConcussionStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Football League
- Responsible party
- Principal investigator, Tamara Espinoza, MD, Emory University
- Investigators
- Tamara Espinoza, MD, MPH, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02529618
- Sponsor's protocol ID
- IRB00082102
- Status last verified
- Mar 2016
- First submitted
- 19 Aug 2015
- Last updated
- 4 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of iDETECT for Field Triage of mTBI in Football Players
- ClinicalTrials.gov ID
- NCT02529618
- Acronym / sponsor ID
- IRB00082102
- Conditions
- Concussion, Brain Trauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Football League
- Study start
- Aug 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 20 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Football Athlete Group | – | 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 GuardAll 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. |
| Non-Collision Sport Athlete Group | – | Device: integrated Display Enhanced Testing for Cognitive Impairment and mild traumatic brain injury (iDETECT)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. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Football Athlete Group, Non-Collision Sport Athlete Group |
| Riddell High Impact Technology (HIT) SystemThe 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 | Device | Football Athlete Group |
| i1 Biometrics Vector Mouth GuardThe 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. | Device | Football Athlete Group |
Primary outcome
Area under the curve (AUC) for iDetect total score of neuropsychological assessment (NP) compared to the trainer's determination of clinical concussion
Time frame: Baseline, throughout duration of sport season (an expected average of 4 months)
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.
Area under the curve (AUC) for iDetect NP total score compared to the Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) score
Time frame: Baseline, throughout duration of sport season (an expected average of 4 months)
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.
Area under the curve (AUC) for iDetect NP response time to stimuli compared to the trainer's determination of clinical concussion
Time frame: Baseline, throughout duration of sport season (an expected average of 4 months)
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.
Area under the curve (AUC) for iDetect NP response time to stimuli compared to Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) score
Time frame: Baseline, throughout duration of sport season (an expected average of 4 months)
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.
Area under the curve (AUC) for iDETECT total score compared to final clinical determination of concussion
Time frame: Baseline, throughout duration of sport season (an expected average of 4 months)
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.
Area under the curve (AUC) for iDETECT total score compared to the Sport Concussion Assessment Tool (SCAT3)
Time frame: Baseline, throughout duration of sport season (an expected average of 4 months)
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.
23 secondary outcomes
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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 interefence compared to trainer's determination of clinical concussion
Time frame: 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 interefence compared to King-Devick score (time and number of errors)
Time frame: Baseline, throughout duration of sport season (an expected average of 4 months)
Change in iDETECT total score from baseline to time of injury
Time frame: Baseline, time of concussion
Change in iDETECT total score from baseline to end of season to assess subconcussion
Time frame: Baseline, end of sport season (an expected average of 4 months)
Change in Sport Concussion Assessment Tool 3 (SCAT3) total score from baseline to end of season to assess subconcussion
Time frame: Baseline, end of sport season (an expected average of 4 months)
iDETECT word recall score post injury
Time frame: 3 days post injury (3 minutes)
Change in iDETECT mean word recall score post injury, 10 days
Time frame: 3 days post injury (3 minutes), 10 days post injury (3 minutes)
Change in iDETECT mean word recall score post injury, 30 days
Time frame: 10 days post injury (3 minutes), 30 days post injury (3 minutes)
iDETECT shapes test score post injury
Time frame: 3 days post injury (2 minutes)
Change in iDETECT mean shapes test score post injury, 10 days
Time frame: 3 days post injury (2 minutes), 10 days post injury (2 minutes)
Change in iDETECT mean shapes test score post injury, 30 days
Time frame: 10 days post injury (3 minutes), 30 days post injury (3 minutes)
iDETECT arrows test score post injury
Time frame: 3 days post injury (2 minutes)
Change in iDETECT mean arrows test score post injury, 10 days
Time frame: 3 days post injury (2 minutes), 10 days post injury (2 minutes)
Change in iDETECT mean arrows test score post injury, 30 days
Time frame: 10 days post injury (2 minutes), 30 days post injury (2 minutes)
iDETECT N-BACK (1-back and 2-back) test post injury
Time frame: 3 days post injury (2 minutes)
iDETECT Delayed Word Recall Test
Time frame: 3 days post injury (2 minutes)
Change in iDETECT Delayed Word Recall Test
Time frame: 3 days post injury (2 minutes), 10 days post injury (2 minutes)
Change in iDETECT Delayed Word Recall Test
Time frame: 10 days post injury (2 minutes), 30 days post injury (2 minutes)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2016.
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Rehabilitation Through Virtual Immersion & Integrated Exposure for Mild Traumatic Brain Injury (ReVIVE for mTBI)
Traumatic Brain Injuries, TBI (Traumatic Brain Injury)
Not yet recruiting
Electroencephalography Markers of Brain Stimulation in Post-Concussion Patients
Patients With Persistent Post-concussion Symptoms
Not yet recruitingObservational study
Cognitive Effects of Hyperbaric Oxygen Therapy (HBOT) After a Traumatic Brain Injury
Traumatic Brain Injury, Post-Concussion Syndrome
Recruiting
Percutaneous Electrical Nerve Field Stimulation (PENFS) in Patients With Post Concussion Syndrome (PCS)
Post-Concussion Syndrome, COVID Long-Haul
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tamara Espinoza, MD, MPH principal investigator
Emory University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Concussion and Brain Trauma, run by Emory University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve (AUC) for iDetect total score of neuropsychological assessment (NP) compared to the trainer's determination of clinical concussion (time frame: Baseline, throughout duration of sport season (an expected average of 4 months)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2016.