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NCT Number: NCT05622344

StableEyes With Active Neurofeedback

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Traditional Therapy

Behavioral

Exercises that teaches subjects to move their heads while viewing still or moving targets.

Other names: Gaze stability exercises

SWAN

Device

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

Other names: StableEyes Training Device with video-oculography

Primary outcomes

  1. Change in Motion sickness intensity as assessed by subjective rating

    Time frame: 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 outcomes

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

    Time frame: 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.

  2. Change in Number of blinks as measured by video-oculography

    Time frame: Daily for up to 4 weeks

    Increase blinking is correlated with worse motion sickness.

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

    Time frame: Daily for up to 4 weeks

    Heart rate in beats per minute will be measured using a monitor worn over the forearm.

  4. Change in Timed Up and Go Plus

    Time frame: 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.

  5. Change in Foam Stance - Eyes Open

    Time frame: 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.

  6. Change in Foam Stance - Eyes Closed

    Time frame: 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.

  7. Change in Foam Stance - Eyes Open with head motion

    Time frame: 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.

  8. Change in Foam Stance - Eyes Closed with head motion

    Time frame: 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.

  9. Change in Gait speed

    Time frame: 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.

  10. Change in Gait endurance

    Time frame: Daily for up to 4 weeks

    Distance walked in 2 minutes, measure in meters.

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

    Time frame: 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.

  12. Change in Rod and Frame Test

    Time frame: Daily for up to 4 weeks

    Subjects adjust a virtual line to their perceived vertical, measured in degrees.

  13. Change in Rod and Disk Test

    Time frame: Daily for up to 4 weeks

    Subjects adjust a virtual line to their perceived vertical, measured in degrees.

  14. Change in Subjective Visual Vertical

    Time frame: Daily for up to 4 weeks

    Subjects adjust a virtual line to their perceived vertical, measured in degrees.

  15. Change in Daily Activity as assessed by an activity monitor

    Time frame: Daily for up to 4 weeks

    Subjects wear an activity monitor on their wrist Data includes daily distance walked .

Study contacts

Contact information is provided by the study sponsor or research team.

Matthew Stewart, MD PhD

CONTACT

[email protected]

4109553492

Michael Schubert, PhD

CONTACT

[email protected]

4108427403

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Aeronautics and Space Administration (NASA)

Registry information

Official study title

StableEyes With Active Neurophysiological Feedback

Acronym: SWAN

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Nov 18, 2022
Registry last updated
Nov 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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