Motion Sickness, Space Motion Sickness, Vestibular Disorder, Vestibular Schwannoma
Conditions
Brief summary
The investigators have developed a self-administered rehabilitation tool that incrementally guides the user to increase head motion to mitigate motion sickness and enhance postural recovery following centrifugation or unilateral vestibular nerve deafferentation surgery.
Detailed description
The rehabilitation device guides users to perform sinusoidal head rotations, matched to a metronome, about the yaw, pitch, and roll axes (60 sec epochs, 5 minutes per axis, 15 min total). The assessment for each axis consists of the number of completed epochs with each epoch requiring head rotations of a different amplitude. Subjects are instructed to begin with an 'easy' amplitude (i.e. small) and increase or decrease amplitude depending on the subject's perception of motion sickness - which is input from 0 (absent motion sick) to 11 (vomit) using a handheld controller. Video-oculography captures eye and head velocity as well as tracks the number of blinks and saccades, metrics that can indicate worsening nausea.
Interventions
BEHAVIORALTraditional Therapy
Exercises that teaches subjects to move their heads while viewing still or moving targets.
DEVICESWAN
The SWAN device uses video-oculography to monitor head motion while guiding participants to move their head in yaw, pitch, roll planes for 15 minutes. Feedback is provided regarding frequency and plane of head rotation
Sponsors
Johns Hopkins University
National Aeronautics and Space Administration (NASA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
At each site, one group will receive the control and the second group will receive the experimental treatment (novel rehab device).
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. In good general health as evidenced by medical history or diagnosed with unilateral vestibular schwannoma 4. Willing to adhere to the SWAN and/or vestibular rehabilitation regimen
Exclusion criteria
1. Current use of anti-nausea medication 2. Presence of cervical spine pathology that limits head motion to \< 30 degrees in the horizontal or vertical plane (i.e. degenerative disc disease, rheumatoid arthritis) 3. Any orthopedic pathology that prevents walking or standing independently (i.e. recent surgery) 4. Legal blindness (20/200 or worse visual acuity) 5. Treatment using a motion sickness investigational drug or other motion sickness behavioral intervention within 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Motion sickness intensity as assessed by subjective rating | Daily for up to 4 weeks | Subjective rating of motion sickness intensity from 0 to 10. Zero denotes absent motion sickness while 10 denote vomiting. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Vestibulo-Ocular Reflex (VOR) gain as measured by video-oculography | Daily for up to 4 weeks | Ratio of eye velocity to head velocity that varies from 0 to 1.2. Normal scores are greater than 0.8. |
| Change in Number of blinks as measured by video-oculography | Daily for up to 4 weeks | Increase blinking is correlated with worse motion sickness. |
| Change in Heart rate as measured by a monitor worn over the forearm | Daily for up to 4 weeks | Heart rate in beats per minute will be measured using a monitor worn over the forearm. |
| Change in Timed Up and Go Plus | Daily for up to 4 weeks | Time measured in seconds for a subject to stand up, step over an obstacle then walk 3M before turning around and sitting down. |
| Change in Foam Stance - Eyes Open | Daily for up to 4 weeks | Time in seconds to stand on foam with eyes open. Inability to stand for less than 20 seconds is associated with 3x greater risk for falling. |
| Change in Foam Stance - Eyes Closed | Daily for up to 4 weeks | Time in seconds to stand on foam with eyes closed. Inability to stand for less than 20 seconds is associated with 3x greater risk for falling. |
| Change in Foam Stance - Eyes Open with head motion | Daily for up to 4 weeks | Time to seconds to stand on foam with eyes open while moving head up and down. Inability to stand for less than 20 seconds is associated with 3x greater risk for falling. |
| Change in Foam Stance - Eyes Closed with head motion | Daily for up to 4 weeks | Time in seconds to stand on foam with eyes closed while moving head up and down. Inability to stand for less than 20 seconds is associated with 3x greater risk for falling. |
| Change in Gait speed | Daily for up to 4 weeks | Velocity to walk 6m within a 10m marked distance, measured in meters/second. Normative data exists based on decade of age. |
| Change in Gait endurance | Daily for up to 4 weeks | Distance walked in 2 minutes, measure in meters. |
| Change in Vertical and torsional alignment nulling test (VAN and TAN) | Daily for up to 4 weeks | Vertical alignment nulling and torsional alignment nulling ask subjects to adjust lines to there perceived horizontal. Measured in degrees. |
| Change in Rod and Frame Test | Daily for up to 4 weeks | Subjects adjust a virtual line to their perceived vertical, measured in degrees. |
| Change in Rod and Disk Test | Daily for up to 4 weeks | Subjects adjust a virtual line to their perceived vertical, measured in degrees. |
| Change in Subjective Visual Vertical | Daily for up to 4 weeks | Subjects adjust a virtual line to their perceived vertical, measured in degrees. |
| Change in Daily Activity as assessed by an activity monitor | Daily for up to 4 weeks | Subjects wear an activity monitor on their wrist Data includes daily distance walked . |
Countries
United States
Contacts
CONTACTMichael Schubert, PhD
CONTACTMatthew Stewart, MD PhD
PRINCIPAL_INVESTIGATORMatthew Stewart, MD PhD
Johns Hopkins University
Outcome results
None listed