StableEyes With Active Neurofeedback

NCT ID: NCT05622344

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-08

Study Completion Date

2026-09-30

Brief Summary

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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

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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.

Conditions

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Vestibular Disorder Vestibular Schwannoma Space Motion Sickness Motion Sickness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

At each site, one group will receive the control and the second group will receive the experimental treatment (novel rehab device).
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Traditional Therapy

Intervention Type BEHAVIORAL

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

SWAN VPT JHU

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

Group Type EXPERIMENTAL

SWAN

Intervention Type 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

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.

Group Type EXPERIMENTAL

SWAN

Intervention Type 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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Traditional Therapy

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

Intervention Type BEHAVIORAL

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

Intervention Type DEVICE

Other Intervention Names

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Gaze stability exercises StableEyes Training Device with video-oculography

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Aeronautics and Space Administration (NASA)

FED

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthew Stewart, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins University

Baltimore, Maryland, United States

Site Status RECRUITING

Naval Medical Research Unit

Dayton, Ohio, United States

Site Status ENROLLING_BY_INVITATION

Countries

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United States

Central Contacts

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Michael Schubert, PhD

Role: CONTACT

Phone: 4108427403

Email: [email protected]

Matthew Stewart, MD PhD

Role: CONTACT

Phone: 4109553492

Email: [email protected]

Facility Contacts

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Michael C Schubert, PhD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 36075099 (View on PubMed)

Related Links

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Other Identifiers

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80NSSC21M0057

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB00281972

Identifier Type: -

Identifier Source: org_study_id