Clinical trial NCT05622344: StableEyes With Active Neurofeedback
Official title: StableEyes With Active Neurophysiological Feedback
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vestibular Disorder
Vestibular Schwannoma
Space Motion Sickness
Motion Sickness
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Aeronautics and Space Administration (NASA)
First posted: 2022-11-18
Enrollment: 48
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: At each site, one group will receive the control and the second group will receive the experimental treatment (novel rehab device).
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Motion sickness intensity as assessed by subjective rating
timeFrame: Daily for up to 4 weeks
Secondary outcomes:
measure: Change in Vestibulo-Ocular Reflex (VOR) gain as measured by video-oculography
timeFrame: Daily for up to 4 weeks
measure: Change in Number of blinks as measured by video-oculography
timeFrame: Daily for up to 4 weeks
measure: Change in Heart rate as measured by a monitor worn over the forearm
timeFrame: Daily for up to 4 weeks
measure: Change in Timed Up and Go Plus
timeFrame: Daily for up to 4 weeks
measure: Change in Foam Stance - Eyes Open
timeFrame: Daily for up to 4 weeks
measure: Change in Foam Stance - Eyes Closed
timeFrame: Daily for up to 4 weeks
measure: Change in Foam Stance - Eyes Open with head motion
timeFrame: Daily for up to 4 weeks
measure: Change in Foam Stance - Eyes Closed with head motion
timeFrame: Daily for up to 4 weeks
measure: Change in Gait speed
timeFrame: Daily for up to 4 weeks
measure: Change in Gait endurance
timeFrame: Daily for up to 4 weeks
measure: Change in Vertical and torsional alignment nulling test (VAN and TAN)
timeFrame: Daily for up to 4 weeks
measure: Change in Rod and Frame Test
timeFrame: Daily for up to 4 weeks
measure: Change in Rod and Disk Test
timeFrame: Daily for up to 4 weeks
measure: Change in Subjective Visual Vertical
timeFrame: Daily for up to 4 weeks
measure: Change in Daily Activity as assessed by an activity monitor
timeFrame: Daily for up to 4 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Dayton
country: United States
facility: Naval Medical Research Unit
state: Ohio
Study officials:
affiliation: Johns Hopkins University
name: Matthew Stewart, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Todd CJ, Schubert MC, Rinaudo CN, Migliaccio AA. Unidirectional Vertical Vestibuloocular Reflex Adaptation in Humans Using 1D and 2D Scenes. Otol Neurotol. 2022 Oct 1;43(9):e1039-e1044. doi: 10.1097/MAO.0000000000003684. Epub 2022 Sep 9.