Vestibular Diseases
Conditions
Keywords
neurologic rehabilitation, computer games
Brief summary
Disorders of vestibular function and balance are an important component of many conditions that commonly affect veterans, such as inner ear diseases, diabetes, and traumatic brain injury. Veterans with vestibular impairment have reduced quality of life, limitations on work and physical activities, and an increased risk of falls. The goal of this research is to develop a more engaging and effective interactive tool for vestibular rehabilitation to improve the lives of affected veterans. The first steps in this process will be to test the ability of the application to facilitate vestibular learning and to test its feasibility in vestibular patients. The hypothesis is that computer-game-based adaptation will induce robust VOR motor learning and will provide an engaging platform for vestibular rehabilitation. Ultimately, our application has the potential to provide more flexible vestibular exercises that will allow therapy to be customized for each patient. It will also have the ability to track a patient's progress over time and to advance exercises as function improves.
Interventions
Video-oculography is used to record the vestibulo-ocular reflex during active and passive turns of the head.
Participants play a custom computer game that is designed to produce motor learning in the vestibulo-ocular reflex
Participants asked to rate their subjective nausea on a numeric scale after playing units of the computer game
Sponsors
Study design
Eligibility
Inclusion criteria
* GROUP 1: Healthy volunteers: Static visual acuity of at least 20/30 at testing distance * GROUP 2: Vestibular patients: Unilateral or bilateral vestibular hypofunction, No central vestibular disorder, Static Visual Acuity of at least 20/30 at testing distance
Exclusion criteria
* GROUP 1: Peripheral or central vestibular disorder * GROUP 2: Central vestibular disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vestibulo-ocular Reflex Gain Ratio | 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. | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Nausea Scale | Immediately after each 10-minute game block, median value calculated for each participant | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 18 |
| 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 | 6 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 6 |
Baseline characteristics
| Characteristic | Total | Vestibular Hypofunction | Normal Volunteers |
|---|---|---|---|
| Activities-specific Balance Confidence scale | 79.5 units on a scale STANDARD_DEVIATION 14 | 79.5 units on a scale STANDARD_DEVIATION 14 | — |
| Age, Continuous | 42 years STANDARD_DEVIATION 17 | 61 years STANDARD_DEVIATION 15 | 35 years STANDARD_DEVIATION 13 |
| Dizziness Handicap Inventory | 31.6 units on a scale STANDARD_DEVIATION 16.7 | 31.6 units on a scale STANDARD_DEVIATION 16.7 | — |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants | 6 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 19 Participants | 5 Participants | 14 Participants |
| Region of Enrollment United States | 24 Participants | 6 Participants | 18 Participants |
| Sex: Female, Male Female | 9 Participants | 0 Participants | 9 Participants |
| Sex: Female, Male Male | 15 Participants | 6 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 6 |
| other Total, other adverse events | 0 / 18 | 0 / 6 |
| serious Total, serious adverse events | 0 / 18 | 0 / 6 |
Outcome results
Vestibulo-ocular Reflex Gain Ratio
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.
Time frame: 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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Normal Volunteers | Vestibulo-ocular Reflex Gain Ratio | 1.15 unitless gain ratio |
Nausea Scale
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.
Time frame: Immediately after each 10-minute game block, median value calculated for each participant
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Vestibular Hypofunction | Nausea Scale | 1.2 score on a scale |