StableEyes With Active Neurofeedback (SWAN)

Johns Hopkins University

Status: Enrolling

Conditions: Vestibular Schwannoma; Motion Sickness; Space Motion Sickness; Vestibular Disorder

Treatments: Device: SWAN; Behavioral: Traditional Therapy

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05622344

IRB00281972

80NSSC21M0057 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 estimated patients

Sex: All

Ages: 21 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 4 patient groups

Traditional Vestibular Physical Therapy (VPT) JHU

Active Comparator group

Description:

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

Treatment:

Behavioral: Traditional Therapy

SWAN VPT JHU

Experimental group

Description:

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

Treatment:

Device: SWAN

SWAN Motion Sick Dayton

Experimental group

Description:

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

Treatment:

Device: SWAN

Traditional Motion Sick Dayton

No Intervention group

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.