Trial Outcomes & Findings for Disparity Driven Vergence in Mild Traumatic Brain Injury (mTBI) (NCT NCT03529799)
NCT ID: NCT03529799
Last Updated: 2022-06-29
Results Overview
Pseudorandom Ternary Sequence of Frequency (reported in Hertz) will be measured via mergence testing using the IPAS goggles.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
15 minutes
Results posted on
2022-06-29
Participant Flow
Participant milestones
| Measure |
Injured Participants
Participants with mild traumatic brain injury (mTBI) tested using the I-PAS goggles
I-PAS Goggles: Portable, head-mounted display goggle system with integrated eye capture technology
|
Uninjured Participants
Participants with no mild traumatic brain injury (mTBI) tested using the I-PAS goggles
I-PAS Goggles: Portable, head-mounted display goggle system with integrated eye capture technology
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
26
|
|
Overall Study
COMPLETED
|
14
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Disparity Driven Vergence in Mild Traumatic Brain Injury (mTBI)
Baseline characteristics by cohort
| Measure |
Injured Participants
n=14 Participants
Participants with mild traumatic brain injury (mTBI) tested using the I-PAS goggles
I-PAS Goggles: Portable, head-mounted display goggle system with integrated eye capture technology
|
Uninjured Participants
n=26 Participants
Participants with no mild traumatic brain injury (mTBI) tested using the I-PAS goggles
I-PAS Goggles: Portable, head-mounted display goggle system with integrated eye capture technology
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.3 years
STANDARD_DEVIATION 16.9 • n=5 Participants
|
33.4 years
STANDARD_DEVIATION 9.7 • n=7 Participants
|
34.05 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucsian · Hispanic
|
8 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucsian · Caucasian
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucsian · Other
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 15 minutesPopulation: All participants
Pseudorandom Ternary Sequence of Frequency (reported in Hertz) will be measured via mergence testing using the IPAS goggles.
Outcome measures
| Measure |
Injured Participants
n=14 Participants
Participants with mild traumatic brain injury (mTBI) tested using the I-PAS goggles
I-PAS Goggles: Portable, head-mounted display goggle system with integrated eye capture technology
|
Uninjured Participants
n=26 Participants
Participants with no mild traumatic brain injury (mTBI) tested using the I-PAS goggles
I-PAS Goggles: Portable, head-mounted display goggle system with integrated eye capture technology
|
|---|---|---|
|
Pseudorandom Ternary Sequence of Frequency
|
0.07 Hertz
Standard Deviation 0.69
|
0.1 Hertz
Standard Deviation 0.54
|
Adverse Events
Injured Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Uninjured Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place