Trial Outcomes & Findings for Eye Movement Recordings in the Diagnosis of Traumatic Brain Injury (NCT NCT00875589)

Results Overview

The ability to keep eye position fixed on a visual target, measured by the distance between the target and eye fixation point averaged over 20 sec.

Recruitment status

COMPLETED

Target enrollment

26 participants

Primary outcome timeframe

During eye movement recording session (20 sec).

Results posted on

2015-11-11

Participant Flow

Participant milestones

Participant milestones
Measure	Controls Control Group - subjects with no Mild Traumatic Brain Injury (MTBI)	MTBI MTBI Group - subjects with diagnosed Mild Traumatic Brain Injury (MTBI)
Overall Study STARTED	15	11
Overall Study COMPLETED	15	11
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Eye Movement Recordings in the Diagnosis of Traumatic Brain Injury

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Controls n=15 Participants Control Group - subjects with no Mild Traumatic Brain Injury (MTBI)	MTBI n=11 Participants MTBI Group - subjects with diagnosed Mild Traumatic Brain Injury (MTBI)	Total n=26 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants	11 Participants n=7 Participants	26 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	2 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: During eye movement recording session (20 sec).

Population: Although there were 15 participants in the Control arm, data were only analyzed for a cohort of 11 that were age-matched to the MTBI arm participants.

The ability to keep eye position fixed on a visual target, measured by the distance between the target and eye fixation point averaged over 20 sec.

Outcome measures

Outcome measures
Measure	Controls n=11 Participants Control Group - subjects with no Mild Traumatic Brain Injury (MTBI)	MTBI n=11 Participants MTBI Group - subjects with diagnosed Mild Traumatic Brain Injury (MTBI)
Stability of Fixation	0.8 degrees Standard Deviation 0.01	1.1 degrees Standard Deviation 0.1

Adverse Events

Controls

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

MTBI

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

Jonathan Jacobs, PhD

Daroff-Dell'Osso Ocular Motility Laboratory

Phone: 216-791-3800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place