StableEyes With Active Neurofeedback

Study Overview
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Brief Summary
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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
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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.

Official Title
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StableEyes With Active Neurophysiological Feedback

Conditions
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Space Motion Sickness, Vestibular Disorder, Vestibular Schwannoma, Motion Sickness

Intervention / Treatment
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* Behavioral: Traditional Therapy
* Device: SWAN


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study In good general health as evidenced by medical history or diagnosed with unilateral vestibular schwannoma Willing to adhere to the SWAN and/or vestibular rehabilitation regimen Exclusion Criteria: Current use of anti-nausea medication 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) Any orthopedic pathology that prevents walking or standing independently (i.e. recent surgery) Legal blindness (20/200 or worse visual acuity) Treatment using a motion sickness investigational drug or other motion sickness behavioral intervention within 30 days

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: At each site, one group will receive the control and the second group will receive the experimental treatment (novel rehab device).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Traditional VPT JHU<br>Subjects that have had their eighth cranial nerve resected will receive traditional vestibular rehabilitation exercises at Johns Hopkins University (JHU) site. | Behavioral: Traditional Therapy<br>* Exercises that teaches subjects to move their heads while viewing still or moving targets.<br>* Other names: Gaze stability exercises;|
| Experimental: SWAN VPT JHU<br>Subjects that have had their eighth cranial nerve resected will receive the automated vestibular rehabilitation method | Device: SWAN<br>* 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<br>* Other names: StableEyes Training Device with video-oculography;|
| Experimental: SWAN Motion Sick Dayton<br>Healthy control subjects that meet similar similar physical characteristics of astronauts will receive the automated vestibular rehabilitation method post motion sickness. | Device: SWAN<br>* 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<br>* Other names: StableEyes Training Device with video-oculography;|
| No Intervention: Traditional Motion Sick Dayton<br>Typically, the suggestion for treating motion sickness once it has started is to avoid motion. Therefore, healthy control subjects that meet similar similar physical characteristics of astronauts will not receive any post motion sickness treatment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Motion sickness intensity as assessed by subjective rating | Subjective rating of motion sickness intensity from 0 to 10. Zero denotes absent motion sickness while 10 denote vomiting. | Daily for up to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Vestibulo-Ocular Reflex (VOR) gain as measured by video-oculography | Ratio of eye velocity to head velocity that varies from 0 to 1.2. Normal scores are greater than 0.8. | Daily for up to 4 weeks | 
| Change in Number of blinks as measured by video-oculography | Increase blinking is correlated with worse motion sickness. | Daily for up to 4 weeks | 
| Change in Heart rate as measured by a monitor worn over the forearm | Heart rate in beats per minute will be measured using a monitor worn over the forearm. | Daily for up to 4 weeks | 
| Change in Timed Up and Go Plus | Time measured in seconds for a subject to stand up, step over an obstacle then walk 3M before turning around and sitting down. | Daily for up to 4 weeks | 
| Change in Foam Stance - Eyes Open | 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. | Daily for up to 4 weeks | 
| Change in Foam Stance - Eyes Closed | 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. | Daily for up to 4 weeks | 
| Change in Foam Stance - Eyes Open with head motion | 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. | Daily for up to 4 weeks | 
| Change in Foam Stance - Eyes Closed with head motion | 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. | Daily for up to 4 weeks | 
| Change in Gait speed | Velocity to walk 6m within a 10m marked distance, measured in meters/second. Normative data exists based on decade of age. | Daily for up to 4 weeks | 
| Change in Gait endurance | Distance walked in 2 minutes, measure in meters. | Daily for up to 4 weeks | 
| Change in Vertical and torsional alignment nulling test (VAN and TAN) | Vertical alignment nulling and torsional alignment nulling ask subjects to adjust lines to there perceived horizontal. Measured in degrees. | Daily for up to 4 weeks | 
| Change in Rod and Frame Test | Subjects adjust a virtual line to their perceived vertical, measured in degrees. | Daily for up to 4 weeks | 
| Change in Rod and Disk Test | Subjects adjust a virtual line to their perceived vertical, measured in degrees. | Daily for up to 4 weeks | 
| Change in Subjective Visual Vertical | Subjects adjust a virtual line to their perceived vertical, measured in degrees. | Daily for up to 4 weeks | 
| Change in Daily Activity as assessed by an activity monitor | Subjects wear an activity monitor on their wrist Data includes daily distance walked . | Daily for up to 4 weeks |