Study Results
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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RECRUITING
NA
48 participants
INTERVENTIONAL
2022-08-08
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
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.
Traditional Therapy
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
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
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.
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
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.
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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
21 Years
70 Years
ALL
Yes
Sponsors
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National Aeronautics and Space Administration (NASA)
FED
Johns Hopkins University
OTHER
Responsible Party
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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
Naval Medical Research Unit
Dayton, Ohio, United States
Countries
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Central Contacts
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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.
Related Links
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Patent for the rehabilitation device
Patent for the integrated video-oculography and rehabilitation device
Other Identifiers
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80NSSC21M0057
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
IRB00281972
Identifier Type: -
Identifier Source: org_study_id