To hear about similar clinical trials, please enter your email below
Trial Title:
StableEyes With Active Neurofeedback
NCT ID:
NCT05622344
Condition:
Vestibular Disorder
Vestibular Schwannoma
Space Motion Sickness
Motion Sickness
Conditions: Official terms:
Neurilemmoma
Neuroma, Acoustic
Vestibular Diseases
Motion Sickness
Space Motion Sickness
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
At each site, one group will receive the control and the second group will receive the
experimental treatment (novel rehab device).
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Traditional Therapy
Description:
Exercises that teaches subjects to move their heads while viewing still or moving
targets.
Arm group label:
Traditional VPT JHU
Other name:
Gaze stability exercises
Intervention type:
Device
Intervention name:
SWAN
Description:
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
Arm group label:
SWAN Motion Sick Dayton
Arm group label:
SWAN VPT JHU
Other name:
StableEyes Training Device with video-oculography
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.
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
21 Years
Maximum age:
70 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Johns Hopkins University
Address:
City:
Baltimore
Zip:
21287
Country:
United States
Status:
Recruiting
Contact:
Last name:
Michael C Schubert, PhD
Phone:
410-955-3403
Email:
mschube1@jhmi.edu
Investigator:
Last name:
Colin R Grove, PhD
Email:
Sub-Investigator
Facility:
Name:
Naval Medical Research Unit
Address:
City:
Dayton
Zip:
45402
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Rich Folga
Email:
richard.folga.2@us.af.mil
Contact backup:
Last name:
Darcy Gallimore
Email:
darci.gallimore.ctr@us.af.mil
Investigator:
Last name:
Richard Folga
Email:
Sub-Investigator
Start date:
August 8, 2022
Completion date:
September 30, 2025
Lead sponsor:
Agency:
Johns Hopkins University
Agency class:
Other
Collaborator:
Agency:
National Aeronautics and Space Administration (NASA)
Agency class:
U.S. Fed
Source:
Johns Hopkins University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05622344
https://patents.google.com/patent/US9782068B2/en
https://patents.google.com/patent/US10136810B2/en?q=migliaccio&inventor=schubert&oq=migliaccio+and+schubert+
