StableEyes With Active Neurofeedback

Vestibular Disorder Clinical Trial

— SWAN  

Official title:

StableEyes With Active Neurophysiological Feedback

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05622344
• Other study ID #: IRB00281972
• Secondary ID: 80NSSC21M0057
• Status: Recruiting
• Phase: N/A
• Start date: August 8, 2022
• Est. completion date: September 30, 2025

Study information

• Verified date: May 2024
• Source: Johns Hopkins University
• Contact: Michael Schubert, PhD
• Phone: 4108427403
• Email: mschube1[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Motion Sickness
• Neurilemmoma
• Neuroma, Acoustic
• Vestibular Diseases
• Vestibular Disorder
• Vestibular Schwannoma

Intervention

Behavioral:
• Traditional Therapy
Exercises that teaches subjects to move their heads while viewing still or moving targets.

Device:
• 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

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	Naval Medical Research Unit	Dayton	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Aeronautics and Space Administration (NASA)

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Daily for up to 4 weeks
Secondary	Change in Number of blinks as measured by video-oculography	Increase blinking is correlated with worse motion sickness.	Daily for up to 4 weeks
Secondary	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.	Daily for up to 4 weeks
Secondary	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.	Daily for up to 4 weeks
Secondary	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.	Daily for up to 4 weeks
Secondary	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.	Daily for up to 4 weeks
Secondary	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.	Daily for up to 4 weeks
Secondary	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.	Daily for up to 4 weeks
Secondary	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.	Daily for up to 4 weeks
Secondary	Change in Gait endurance	Distance walked in 2 minutes, measure in meters.	Daily for up to 4 weeks
Secondary	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.	Daily for up to 4 weeks
Secondary	Change in Rod and Frame Test	Subjects adjust a virtual line to their perceived vertical, measured in degrees.	Daily for up to 4 weeks
Secondary	Change in Rod and Disk Test	Subjects adjust a virtual line to their perceived vertical, measured in degrees.	Daily for up to 4 weeks
Secondary	Change in Subjective Visual Vertical	Subjects adjust a virtual line to their perceived vertical, measured in degrees.	Daily for up to 4 weeks
Secondary	Change in Daily Activity as assessed by an activity monitor	Subjects wear an activity monitor on their wrist Data includes daily distance walked .	Daily for up to 4 weeks

External Links

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