Concussion, MildNCT04381767
EYE-SYNC Concussion Classification Study
An observational study of Concussion, Mild and Concussion; Eye, run by Sync-Think, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to determine the sensitivity and specificity of an aid in assessment of concussion based on eye-tracking, in comparison to a clinical reference standard appropriate for sport-related concussion evaluation. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Concussion, Mild, Concussion; Eye, Concussion, Brain
- What is being tested?
- EYE-SYNC
- Type of treatment
- Medical device
- How many people
- 1,303 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2018to 23 Jun 2020
- 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 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants will include all patients evaluated for potential traumatic brain injury presenting to the sports medicine clinicians in an athletic environment.
Who may be able to join
- Men and women actively engaged in competitive athletics
- Eye tracking measurements and SCAT5 evaluations are collected within 3-day window
- Eye tracking measurements and SCAT5 evaluations are collected within 3 days of injury
Who cannot join
- Prior enrollment (subjects may only enroll once)
- POOR eye tracking data quality
- Subjects without reported injury detailing alteration of consciousness (AOC) or altered mental status (AMS) defined as self-report, witness report or the following responses to the SCAT5 SSS: "Difficulty Remembering" ≥ 4 or "Confusion" ≥ 4, or scored less than 23 on the SCAT5 Standardized Assessment of Concussion (SAC) or greater than 25 on the SCAT5 Symptom Severity Score (SSS)
- EYE-SYNC smooth pursuit standard deviation of tangential error (SDTE) variance scores < 2.0
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the sensitivity and specificity of an aid in assessment of concussion based on eye-tracking, in comparison to a clinical reference standard appropriate for sport-related concussion evaluation.
- Conditions
- Concussion, Mild, Concussion; Eye, Concussion, Brain, Concussion, Severe, Brain Injuries, Concussion, Cerebral
- Being tested
- EYE-SYNC
- Medical subject headings
- Brain Concussion, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EYE-SYNCDevice
Also called SCAT-5
Evaluation of oculomotor performance using visual presentation and eye tracking analysis
| Study group | Role | What they receive |
|---|---|---|
| Concussion Evaluation | Adult athletes receiving a clinical evaluation for a suspected concussion after head injury Receives: Device: EYE-SYNC |
What is being measured
The primary outcome is the main question the study is designed to answer.
A change in metrics of eye movement that enable positive concussion detection using EYE-SYNC metrics
A True Positive and True Negative rate for identifying Concussion as compared to a Clinical Reference standard.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start19 Dec 2018
- Primary completion23 Mar 2020
- Study completion23 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Concussion, MildStudies of the same condition, open and under way.
- 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 only
- Time perspective
- Retrospective
- Enrolment
- 1,303 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sync-Think, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04381767
- Sponsor's protocol ID
- EYESYNCCCV2020
- Status last verified
- Jun 2020
- First submitted
- 6 May 2020
- Last updated
- 25 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EYE-SYNC Concussion Classification Study
- ClinicalTrials.gov ID
- NCT04381767
- Acronym / sponsor ID
- EYESYNCCCV2020
- Conditions
- Concussion, Mild, Concussion; Eye, Concussion, Brain, Concussion, Severe, Brain Injuries, Concussion, Cerebral
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,303 participants (actual)
- Lead sponsor
- Sync-Think, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Dec 2018 (actual)
- Primary completion
- 23 Mar 2020 (actual)
- Study completion
- 23 Jun 2020 (actual)
- First posted
- 11 May 2020 (actual)
- 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 determine the sensitivity and specificity of an aid in assessment of concussion based on eye-tracking, in comparison to a clinical reference standard appropriate for sport-related concussion evaluation.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Concussion Evaluation | – | Device: EYE-SYNCAdult athletes receiving a clinical evaluation for a suspected concussion after head injury |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants will include all patients evaluated for potential traumatic brain injury presenting to the sports medicine clinicians in an athletic environment.
Key inclusion criteria (3 listed)
- Men and women actively engaged in competitive athletics
- Eye tracking measurements and SCAT5 evaluations are collected within 3-day window
- Eye tracking measurements and SCAT5 evaluations are collected within 3 days of injury
Key exclusion criteria (4 listed)
- Prior enrollment (subjects may only enroll once)
- POOR eye tracking data quality
- Subjects without reported injury detailing alteration of consciousness (AOC) or altered mental status (AMS) defined as self-report, witness report or the following responses to the SCAT5 SSS: "Difficulty Remembering" ≥ 4 or "Confusion" ≥ 4, or scored less than 23 on the SCAT5 Standardized Assessment of Concussion (SAC) or greater than 25 on the SCAT5 Symptom Severity Score (SSS)
- EYE-SYNC smooth pursuit standard deviation of tangential error (SDTE) variance scores < 2.0
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 |
|---|---|---|
| EYE-SYNCAlso: SCAT-5Evaluation of oculomotor performance using visual presentation and eye tracking analysis | Device | Concussion Evaluation |
Primary outcome
A change in metrics of eye movement that enable positive concussion detection using EYE-SYNC metrics
Time frame: 3 days
A True Positive and True Negative rate for identifying Concussion as compared to a Clinical Reference standard.
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 25 Jun 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Concussion, Mild and Concussion; Eye, run by Sync-Think, Inc. at 1 site 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 3 inclusion and 4 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 25 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
A change in metrics of eye movement that enable positive concussion detection using EYE-SYNC metrics (time frame: 3 days). 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 25 Jun 2020.