StableEyes With Active Neurofeedback (SWAN)

StableEyes With Active Neurophysiological Feedback

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.

Study Overview

• Status: Recruiting
• Conditions: Motion Sickness; Vestibular Schwannoma; Vestibular Disorder; Space Motion Sickness
• Intervention / Treatment: Behavioral: Traditional Therapy; Device: SWAN

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.

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael Schubert, PhD; Phone Number: 4108427403; Email: mschube1@jhmi.edu
• Study Contact Backup: Name: Matthew Stewart, MD PhD; Phone Number: 4109553492; Email: cstewa16@jhmi.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Recruiting
      • Johns Hopkins University
      • Contact: Michael C Schubert, PhD; Phone Number: 410-955-3403; Email: mschube1@jhmi.edu
      • Sub-Investigator: Colin R Grove, PhD
  • Ohio
    • Dayton, Ohio, United States, 45433
      • Enrolling by invitation
      • Naval Medical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SWAN VPT JHU; Subjects that have had their eighth cranial nerve resected will receive the automated vestibular rehabilitation method	Device: SWAN; 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
Experimental: SWAN Motion Sick Dayton; Healthy control subjects that meet similar similar physical characteristics of astronauts will receive the automated vestibular rehabilitation method post motion sickness.	Device: SWAN; 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
No Intervention: Traditional Motion Sick Dayton; 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.
Active Comparator: Traditional Vestibular Physical Therapy (VPT) JHU; Subjects that have had their eighth cranial nerve resected will receive traditional vestibular rehabilitation exercises at Johns Hopkins University (JHU) site.	Behavioral: Traditional Therapy; Exercises that teaches subjects to move their heads while viewing still or moving targets.; Other Names: Gaze stability exercises

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Aeronautics and Space Administration (NASA)
• Investigators: Principal Investigator: Matthew Stewart, MD PhD, Johns Hopkins University

Publications and helpful links

General Publications

• 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.

Helpful Links

• Patent for the rehabilitation device
• Patent for the integrated video-oculography and rehabilitation device

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2022
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: November 11, 2022
• First Submitted That Met QC Criteria: November 11, 2022
• First Posted (Actual): November 18, 2022

Study Record Updates

• Last Update Posted (Estimated): November 7, 2025
• Last Update Submitted That Met QC Criteria: November 6, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Otorhinolaryngologic Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nervous System Neoplasms; Nerve Sheath Neoplasms; Peripheral Nervous System Neoplasms; Neuroendocrine Tumors; Ear Diseases; Otorhinolaryngologic Neoplasms; Cranial Nerve Diseases; Neuroma; Cranial Nerve Neoplasms; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Neurilemmoma; Labyrinth Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Vestibular Diseases; Neuroma, Acoustic; Motion Sickness; Space Motion Sickness
• Other Study ID Numbers: IRB00281972; 80NSSC21M0057 (Other Grant/Funding Number: NASA)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Currently, we have no plan to share data with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No