StableEyes With Active Neurofeedback
- Conditions
- Motion SicknessVestibular DisorderVestibular SchwannomaSpace Motion Sickness
- Interventions
- Device: SWANBehavioral: Traditional Therapy
- Registration Number
- NCT05622344
- Lead Sponsor
- Johns Hopkins University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 48
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SWAN Motion Sick Dayton SWAN Healthy control subjects that meet similar similar physical characteristics of astronauts will receive the automated vestibular rehabilitation method post motion sickness. Traditional VPT JHU Traditional Therapy Subjects that have had their eighth cranial nerve resected will receive traditional vestibular rehabilitation exercises at Johns Hopkins University (JHU) site. SWAN VPT JHU SWAN Subjects that have had their eighth cranial nerve resected will receive the automated vestibular rehabilitation method
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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 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 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 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 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 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 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 Rod and Disk Test Daily for up to 4 weeks Subjects adjust a virtual line to their perceived vertical, measured in degrees.
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 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 .
Change in Subjective Visual Vertical Daily for up to 4 weeks Subjects adjust a virtual line to their perceived vertical, measured in degrees.
Trial Locations
- Locations (2)
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
Naval Medical Research Unit
🇺🇸Dayton, Ohio, United States