Trial Outcomes & Findings for EYE-TRAC Advance: Technology Verification (ETA-TV) Cohort 2 (NCT NCT02877732)
NCT ID: NCT02877732
Last Updated: 2018-05-30
Results Overview
The EYE-SYNC test will be performed immediately after an impact, 2 days, 7 days and 14 days post impact. The movement of eye will be tracked using EYE-SYNC. The data will be recorded in a surface tablet connected to EYE-SYNC.
TERMINATED
NA
12 participants
Immediate post impact, 2 days, 7 days and 14 days post impact.
2018-05-30
Participant Flow
Participant milestones
| Measure |
Concussed Subject
EYE-SYNC eye-tracking device, Level of Alertness, SCAT-3 subtests (Symptom, Immediate memory, Balance and Orientation), Simple Reaction Time subtest of ANAM-SRT and DEM.
|
Control Subject
EYE-SYNC eye-tracking device, Level of Alertness, SCAT-3 subtests (Symptom, Immediate memory, Balance and Orientation), Simple Reaction Time subtest of ANAM-SRT and DEM.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Concussed Subject
n=6 Participants
EYE-SYNC eye-tracking device, Level of Alertness, SCAT-3 subtests (Symptom, Immediate memory, Balance and Orientation), Simple Reaction Time subtest of ANAM-SRT and DEM.
|
Control Subject
n=6 Participants
EYE-SYNC eye-tracking device, Level of Alertness, SCAT-3 subtests (Symptom, Immediate memory, Balance and Orientation), Simple Reaction Time subtest of ANAM-SRT and DEM.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
20 years
n=6 Participants
|
20 years
n=6 Participants
|
20 years
n=12 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=12 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
10 Participants
n=12 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Immediate post impact, 2 days, 7 days and 14 days post impact.Population: Study was cancelled by the funder prior to collection of any outcome data; only screening procedures were performed.
The EYE-SYNC test will be performed immediately after an impact, 2 days, 7 days and 14 days post impact. The movement of eye will be tracked using EYE-SYNC. The data will be recorded in a surface tablet connected to EYE-SYNC.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Immediate post impact, 2 days, 7 days and 14 days post impact.Population: Study was cancelled by the funder prior to collection of any outcome data; only screening procedures were performed.
The integrity will be analyzed based on the score obtained from EYE-SYNC device.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Immediate post impact, 2 days, 7 days and 14 days post impact.Population: Study was cancelled by the funder prior to collection of any outcome data; only screening procedures were performed.
The reliability will be analyzed based on the score obtained from EYE-SYNC.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Immediate post impact, 2 days, 7 days and 14 days post impact.Population: Study was cancelled by the funder prior to collection of any outcome data; only screening procedures were performed.
The SCAT-3 result and EYE-SYNC score will be compared.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Immediate post impact, 2 days, 7 days and 14 days post impact.Population: Study was cancelled by the funder prior to collection of any outcome data; only screening procedures were performed.
The Automated Neuropsychological Assessment Metrics-Simple Reaction Time (ANAM-SRT) evaluation and EYE-SYNC score will be compared.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Immediate post impact, 2 days, 7 days and 14 days post impact.Population: Study was cancelled by the funder prior to collection of any outcome data; only screening procedures were performed.
The Developmental Eye Movement (DEM) assessment and EYE-SYNC score will be compared.
Outcome measures
Outcome data not reported
Adverse Events
Concussed Subject
Control Subject
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Jamshid Ghajar
Stanford Concussion and Brain Performance Center/ Stanford Emergency Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place