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StableEyes With Active Neurophysiological Feedback

NCT ID: NCT05622344Sponsor: Johns Hopkins UniversityLast updated: 2025-11-10

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.

Arms & 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

Outcome measures

Primary

  • 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.

    Time frame: Daily for up to 4 weeks

Secondary

  • Change in Vestibulo-Ocular Reflex (VOR) gain as measured by video-oculography

    Time frame: Daily for up to 4 weeks

  • Change in Number of blinks as measured by video-oculography

    Time frame: Daily for up to 4 weeks

  • Change in Heart rate as measured by a monitor worn over the forearm

    Time frame: Daily for up to 4 weeks

  • Change in Timed Up and Go Plus

    Time frame: Daily for up to 4 weeks

  • Change in Foam Stance - Eyes Open

    Time frame: Daily for up to 4 weeks

  • Change in Foam Stance - Eyes Closed

    Time frame: Daily for up to 4 weeks

  • Change in Foam Stance - Eyes Open with head motion

    Time frame: Daily for up to 4 weeks

  • Change in Foam Stance - Eyes Closed with head motion

    Time frame: Daily for up to 4 weeks

  • Change in Gait speed

    Time frame: Daily for up to 4 weeks

  • Change in Gait endurance

    Time frame: Daily for up to 4 weeks

  • Change in Vertical and torsional alignment nulling test (VAN and TAN)

    Time frame: Daily for up to 4 weeks

  • Change in Rod and Frame Test

    Time frame: Daily for up to 4 weeks

  • Change in Rod and Disk Test

    Time frame: Daily for up to 4 weeks

  • Change in Subjective Visual Vertical

    Time frame: Daily for up to 4 weeks

  • Change in Daily Activity as assessed by an activity monitor

    Time frame: Daily for up to 4 weeks

Eligibility criteria

Sex: AllAge: 21 Years to 70 YearsHealthy 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

Study locations (2)

Johns Hopkins University

Baltimore, Maryland, 21287

Recruiting
Michael C Schubert, PhD · Contact
Colin R Grove, PhD · Sub Investigator

Naval Medical Research Unit

Dayton, Ohio, 45433

Enrolling By Invitation

References

  • 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.(PubMed)
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