Trial Outcomes & Findings for Computerized Vestibular Rehabilitation (NCT NCT03589859)
NCT ID: NCT03589859
Last Updated: 2024-11-26
Results Overview
The vestibulo-ocular reflex gain is the relationship between a rotation of the head and the evoked eye movement. The outcome measure is the ratio of the VOR gain after training to that before training. VOR gain is determined by a scaled fit of eye speed to evoking head speed (normal gain is 1). Note that this experiment was not a treatment of impairment but a test of the ability of the vestibular game to elicit motor learning (away from normal) in individuals with intact motor learning. In that context, an increase in the gain to a value greater than unity (faster eye movement relative to the head movement) is "better" with respect to the training goal, but it is not "better" with respect to real-world visual function, for which a gain of one is the goal. There is no threshold value for this type of motor learning experiment. Instead, the question is whether the gain is increased after training, and if so, by what percentage relative to the training goal.
COMPLETED
24 participants
VOR measurements to determine gain were performed immediately before and after each approximately 30 minute training session. Pre- and post-training gains were then combined in the VOR gain ratio to determine the training effect.
2024-11-26
Participant Flow
Participant milestones
| Measure |
Normal Volunteers
Healthy individuals with intact vestibular function
VOR Test: Video-oculography is used to record the vestibulo-ocular reflex during active and passive turns of the head.
Computer Game: Participants play a custom computer game that is designed to produce motor learning in the vestibulo-ocular reflex
|
Vestibular Hypofunction
Veterans with peripheral vestibular hypofunction
VOR Test: Video-oculography is used to record the vestibulo-ocular reflex during active and passive turns of the head.
Computer Game: Participants play a custom computer game that is designed to produce motor learning in the vestibulo-ocular reflex
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
6
|
|
Overall Study
COMPLETED
|
18
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
6
|
Reasons for withdrawal
| Measure |
Normal Volunteers
Healthy individuals with intact vestibular function
VOR Test: Video-oculography is used to record the vestibulo-ocular reflex during active and passive turns of the head.
Computer Game: Participants play a custom computer game that is designed to produce motor learning in the vestibulo-ocular reflex
|
Vestibular Hypofunction
Veterans with peripheral vestibular hypofunction
VOR Test: Video-oculography is used to record the vestibulo-ocular reflex during active and passive turns of the head.
Computer Game: Participants play a custom computer game that is designed to produce motor learning in the vestibulo-ocular reflex
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
6
|
Baseline Characteristics
Assessed only in participants with vestibular dysfunction
Baseline characteristics by cohort
| Measure |
Normal Volunteers
n=18 Participants
Healthy individuals with intact vestibular function
VOR Test: Video-oculography is used to record the vestibulo-ocular reflex during active and passive turns of the head.
Computer Game: Participants play a custom computer game that is designed to produce motor learning in the vestibulo-ocular reflex
|
Vestibular Hypofunction
n=6 Participants
Veterans with peripheral vestibular hypofunction
VOR Test: Video-oculography is used to record the vestibulo-ocular reflex during active and passive turns of the head.
Computer Game: Participants play a custom computer game that is designed to produce motor learning in the vestibulo-ocular reflex
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35 years
STANDARD_DEVIATION 13 • n=18 Participants
|
61 years
STANDARD_DEVIATION 15 • n=6 Participants
|
42 years
STANDARD_DEVIATION 17 • n=24 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=18 Participants
|
0 Participants
n=6 Participants
|
9 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=18 Participants
|
6 Participants
n=6 Participants
|
15 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=18 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=18 Participants
|
6 Participants
n=6 Participants
|
22 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=18 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=18 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=18 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=18 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=18 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=18 Participants
|
5 Participants
n=6 Participants
|
19 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=18 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=18 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
18 Participants
n=18 Participants
|
6 Participants
n=6 Participants
|
24 Participants
n=24 Participants
|
|
Dizziness Handicap Inventory
|
—
|
31.6 units on a scale
STANDARD_DEVIATION 16.7 • n=6 Participants • Assessed only in participants with vestibular dysfunction
|
31.6 units on a scale
STANDARD_DEVIATION 16.7 • n=6 Participants • Assessed only in participants with vestibular dysfunction
|
|
Activities-specific Balance Confidence scale
|
—
|
79.5 units on a scale
STANDARD_DEVIATION 14.0 • n=6 Participants • Assessed only in participants with vestibular dysfunction
|
79.5 units on a scale
STANDARD_DEVIATION 14.0 • n=6 Participants • Assessed only in participants with vestibular dysfunction
|
PRIMARY outcome
Timeframe: VOR measurements to determine gain were performed immediately before and after each approximately 30 minute training session. Pre- and post-training gains were then combined in the VOR gain ratio to determine the training effect.Population: This measure applied only to Group 1: healthy individuals with intact vestibular function
The vestibulo-ocular reflex gain is the relationship between a rotation of the head and the evoked eye movement. The outcome measure is the ratio of the VOR gain after training to that before training. VOR gain is determined by a scaled fit of eye speed to evoking head speed (normal gain is 1). Note that this experiment was not a treatment of impairment but a test of the ability of the vestibular game to elicit motor learning (away from normal) in individuals with intact motor learning. In that context, an increase in the gain to a value greater than unity (faster eye movement relative to the head movement) is "better" with respect to the training goal, but it is not "better" with respect to real-world visual function, for which a gain of one is the goal. There is no threshold value for this type of motor learning experiment. Instead, the question is whether the gain is increased after training, and if so, by what percentage relative to the training goal.
Outcome measures
| Measure |
Normal Volunteers
n=18 Participants
Healthy individuals with intact vestibular function
VOR Test: Video-oculography is used to record the vestibulo-ocular reflex during active and passive turns of the head.
Computer Game: Participants play a custom computer game that is designed to produce motor learning in the vestibulo-ocular reflex
|
Vestibular Hypofunction
Veterans with vestibular hypofunction
|
|---|---|---|
|
Vestibulo-ocular Reflex Gain Ratio
|
1.15 unitless gain ratio
Interval 1.1 to 1.2
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Immediately after each 10-minute game block, median value calculated for each participantPopulation: This measure applied only to Group 2: participants with vestibular dysfunction. Of the 6 enrolled participants in this group, one chose not to complete the game playing after consenting, and a second was found to have recovery of his vestibular function before game playing. The reported data are from the remaining four participants.
Participants with vestibular hypofunction rated their nausea after each game block on a scale of 1 to 10. For each visit, there were up to 3 game-blocks, each of 10-minutes duration. The number of blocks was determined by the participant. A higher score is a worse outcome (more nausea). The average nausea scale rating was determined for each participant. The final result is the median of these averaged scores.
Outcome measures
| Measure |
Normal Volunteers
Healthy individuals with intact vestibular function
VOR Test: Video-oculography is used to record the vestibulo-ocular reflex during active and passive turns of the head.
Computer Game: Participants play a custom computer game that is designed to produce motor learning in the vestibulo-ocular reflex
|
Vestibular Hypofunction
n=4 Participants
Veterans with vestibular hypofunction
|
|---|---|---|
|
Nausea Scale
|
—
|
1.2 score on a scale
Interval 0.0 to 4.5
|
Adverse Events
Normal Volunteers
Vestibular Hypofunction
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