EYE-SYNC Concussion Classification Study | NCT04381767

Studies
EYE-SYNC Concussion Classification Study

NCT04381767

Sponsor

Sync-Think, Inc.

Status

Completed

Last Update Posted

Jun 25, 2020Actual

Enrollment

1,303Actual

Phase

Not provided

Conditions

Concussion, Mild
Concussion; Eye
Concussion, Brain
Concussion, Severe
Brain Injuries
Concussion, Cerebral

Interventions

EYE-SYNC

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 19, 2018Actual

Primary Completion Date

Mar 23, 2020Actual

Completion Date

Jun 23, 2020Actual

First Submitted Date

May 6, 2020

First Submission Date that Met QC Criteria

May 6, 2020

First Posted Date

May 11, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2020

Last Update Posted Date

Jun 25, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,303Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Concussion Evaluation		Adult athletes receiving a clinical evaluation for a suspected concussion after head injury	Device: EYE-SYNC

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EYE-SYNC	Device	Evaluation of oculomotor performance using visual presentation and eye tracking analysis	Concussion Evaluation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	3 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

17 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Participants will include all patients evaluated for potential traumatic brain injury presenting to the sports medicine clinicians in an athletic environment.

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Sync-Think, Inc.		Palo Alto	California	94306	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001924	Brain Concussion
D001930	Brain Injuries

Ancestor Terms

ID	Term
D000070642	Brain Injuries, Traumatic
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided