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StableEyes With Active Neurofeedback (SWAN)

Primary Purpose

Vestibular Disorder, Vestibular Schwannoma, Space Motion Sickness

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Traditional Therapy
SWAN
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vestibular Disorder

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Johns Hopkins UniversityRecruiting
  • Naval Medical Research Unit

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

No Intervention

Arm Label

Traditional VPT JHU

SWAN VPT JHU

SWAN Motion Sick Dayton

Traditional Motion Sick Dayton

Arm Description

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

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

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Change in Number of blinks as measured by video-oculography
Increase blinking is correlated with worse motion sickness.
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.
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.
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.
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.
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.
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.
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.
Change in Gait endurance
Distance walked in 2 minutes, measure in meters.
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.
Change in Rod and Frame Test
Subjects adjust a virtual line to their perceived vertical, measured in degrees.
Change in Rod and Disk Test
Subjects adjust a virtual line to their perceived vertical, measured in degrees.
Change in Subjective Visual Vertical
Subjects adjust a virtual line to their perceived vertical, measured in degrees.
Change in Daily Activity as assessed by an activity monitor
Subjects wear an activity monitor on their wrist Data includes daily distance walked .

Full Information

First Posted
November 11, 2022
Last Updated
May 11, 2023
Sponsor
Johns Hopkins University
Collaborators
National Aeronautics and Space Administration (NASA)
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1. Study Identification

Unique Protocol Identification Number
NCT05622344
Brief Title
StableEyes With Active Neurofeedback
Acronym
SWAN
Official Title
StableEyes With Active Neurophysiological Feedback
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 8, 2022 (Actual)
Primary Completion Date
September 30, 2025 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Aeronautics and Space Administration (NASA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vestibular Disorder, Vestibular Schwannoma, Space Motion Sickness, Motion Sickness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
At each site, one group will receive the control and the second group will receive the experimental treatment (novel rehab device).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Traditional VPT JHU
Arm Type
Active Comparator
Arm Description
Subjects that have had their eighth cranial nerve resected will receive traditional vestibular rehabilitation exercises at Johns Hopkins University (JHU) site.
Arm Title
SWAN VPT JHU
Arm Type
Experimental
Arm Description
Subjects that have had their eighth cranial nerve resected will receive the automated vestibular rehabilitation method
Arm Title
SWAN Motion Sick Dayton
Arm Type
Experimental
Arm Description
Healthy control subjects that meet similar similar physical characteristics of astronauts will receive the automated vestibular rehabilitation method post motion sickness.
Arm Title
Traditional Motion Sick Dayton
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Traditional Therapy
Other Intervention Name(s)
Gaze stability exercises
Intervention Description
Exercises that teaches subjects to move their heads while viewing still or moving targets.
Intervention Type
Device
Intervention Name(s)
SWAN
Other Intervention Name(s)
StableEyes Training Device with video-oculography
Intervention 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
Primary Outcome Measure Information:
Title
Change in Motion sickness intensity as assessed by subjective rating
Description
Subjective rating of motion sickness intensity from 0 to 10. Zero denotes absent motion sickness while 10 denote vomiting.
Time Frame
Daily for up to 4 weeks
Secondary Outcome Measure Information:
Title
Change in Vestibulo-Ocular Reflex (VOR) gain as measured by video-oculography
Description
Ratio of eye velocity to head velocity that varies from 0 to 1.2. Normal scores are greater than 0.8.
Time Frame
Daily for up to 4 weeks
Title
Change in Number of blinks as measured by video-oculography
Description
Increase blinking is correlated with worse motion sickness.
Time Frame
Daily for up to 4 weeks
Title
Change in Heart rate as measured by a monitor worn over the forearm
Description
Heart rate in beats per minute will be measured using a monitor worn over the forearm.
Time Frame
Daily for up to 4 weeks
Title
Change in Timed Up and Go Plus
Description
Time measured in seconds for a subject to stand up, step over an obstacle then walk 3M before turning around and sitting down.
Time Frame
Daily for up to 4 weeks
Title
Change in Foam Stance - Eyes Open
Description
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.
Time Frame
Daily for up to 4 weeks
Title
Change in Foam Stance - Eyes Closed
Description
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.
Time Frame
Daily for up to 4 weeks
Title
Change in Foam Stance - Eyes Open with head motion
Description
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.
Time Frame
Daily for up to 4 weeks
Title
Change in Foam Stance - Eyes Closed with head motion
Description
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.
Time Frame
Daily for up to 4 weeks
Title
Change in Gait speed
Description
Velocity to walk 6m within a 10m marked distance, measured in meters/second. Normative data exists based on decade of age.
Time Frame
Daily for up to 4 weeks
Title
Change in Gait endurance
Description
Distance walked in 2 minutes, measure in meters.
Time Frame
Daily for up to 4 weeks
Title
Change in Vertical and torsional alignment nulling test (VAN and TAN)
Description
Vertical alignment nulling and torsional alignment nulling ask subjects to adjust lines to there perceived horizontal. Measured in degrees.
Time Frame
Daily for up to 4 weeks
Title
Change in Rod and Frame Test
Description
Subjects adjust a virtual line to their perceived vertical, measured in degrees.
Time Frame
Daily for up to 4 weeks
Title
Change in Rod and Disk Test
Description
Subjects adjust a virtual line to their perceived vertical, measured in degrees.
Time Frame
Daily for up to 4 weeks
Title
Change in Subjective Visual Vertical
Description
Subjects adjust a virtual line to their perceived vertical, measured in degrees.
Time Frame
Daily for up to 4 weeks
Title
Change in Daily Activity as assessed by an activity monitor
Description
Subjects wear an activity monitor on their wrist Data includes daily distance walked .
Time Frame
Daily for up to 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Schubert, PhD
Phone
4108427403
Email
mschube1@jhmi.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew Stewart, MD PhD
Phone
4109553492
Email
cstewa16@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Stewart, MD PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael C Schubert, PhD
Phone
410-955-3403
Email
mschube1@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Colin R Grove, PhD
Facility Name
Naval Medical Research Unit
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45402
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Preston, DO
Email
adam.preston.2@us.af.mil
First Name & Middle Initial & Last Name & Degree
Darcy Gallimore
Email
darci.gallimore.ctr@us.af.mil
First Name & Middle Initial & Last Name & Degree
Richard Folga

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Currently, we have no plan to share data with other researchers
Citations:
PubMed Identifier
36075099
Citation
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.
Results Reference
background
Links:
URL
https://patents.google.com/patent/US9782068B2/en
Description
Patent for the rehabilitation device
URL
https://patents.google.com/patent/US10136810B2/en?q=migliaccio&inventor=schubert&oq=migliaccio+and+schubert+
Description
Patent for the integrated video-oculography and rehabilitation device

Learn more about this trial

StableEyes With Active Neurofeedback

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