StableEyes With Active Neurofeedback

NCT05622344 | Recruiting

• 2 other identifiers: IRB0028197280NSSC21M0057
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

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.

Conditions

Vestibular Disorder; Vestibular Schwannoma; Space Motion Sickness; Motion Sickness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

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

  Daily for up to 4 weeks

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

  Daily for up to 4 weeks

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

  Daily for up to 4 weeks

• Change in Timed Up and Go Plus

  Daily for up to 4 weeks

• Change in Foam Stance - Eyes Open

  Daily for up to 4 weeks

Study Arms (4)

Traditional Vestibular Physical Therapy (VPT) JHU

ACTIVE COMPARATOR

Subjects that have had their eighth cranial nerve resected will receive traditional vestibular rehabilitation exercises at Johns Hopkins University (JHU) site.

Behavioral: Traditional Therapy

SWAN VPT JHU

EXPERIMENTAL

Subjects that have had their eighth cranial nerve resected will receive the automated vestibular rehabilitation method

Device: SWAN

SWAN Motion Sick Dayton

EXPERIMENTAL

Healthy control subjects that meet similar similar physical characteristics of astronauts will receive the automated vestibular rehabilitation method post motion sickness.

Device: SWAN

Traditional Motion Sick Dayton

NO INTERVENTION

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.

Interventions

Traditional Therapy BEHAVIORAL

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

Also known as: Gaze stability exercises

Traditional Vestibular Physical Therapy (VPT) JHU

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

Also known as: StableEyes Training Device with video-oculography

SWAN Motion Sick Dayton; SWAN VPT JHU

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Aeronautics and Space Administration (NASA): collaborator

Study Sites (2)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

RECRUITING

Naval Medical Research Unit

Dayton, Ohio, 45433, United States

ENROLLING BY INVITATION

Related Publications (1)

• 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.

  PMID: 36075099 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Vestibular Diseases; Neuroma, Acoustic; Space Motion Sickness; Motion Sickness

Condition Hierarchy (Ancestors)

Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurilemmoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neuroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Cranial Nerve Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Peripheral Nervous System Neoplasms; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Otorhinolaryngologic Neoplasms; Cranial Nerve Diseases; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Matthew Stewart, MD PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Schubert, PhD

CONTACT

4108427403; mschube1@jhmi.edu

Matthew Stewart, MD PhD

CONTACT

4109553492; cstewa16@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: At each site, one group will receive the control and the second group will receive the experimental treatment (novel rehab device).

Study Record Dates

• First Submitted: November 11, 2022
• First Posted: November 18, 2022
• Study Start: August 8, 2022
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)