StableEyes With Active Neurofeedback

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StableEyes With Active Neurofeedback

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	21 Years - 70 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05622344
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Johns Hopkins University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Matthew Stewart, MD PhD
Principal Investigator Affiliation	Johns Hopkins University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, U.S. Fed
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Vestibular Disorder, Vestibular Schwannoma, Space Motion Sickness, Motion Sickness
Study Website:	View Trial Website

Additional Details

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.

Arms & Interventions

Arms

Active Comparator: 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.

Experimental: SWAN VPT JHU

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

Experimental: 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.

No Intervention: 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.

Interventions

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Johns Hopkins University, Baltimore, Maryland

Status

Recruiting

Address

Johns Hopkins University

Baltimore, Maryland, 21287

Site Contact

Michael C Schubert, PhD

[email protected]

410-955-3403

Naval Medical Research Unit, Dayton, Ohio

Status