Health TrialsbyHealthPanel

StableEyes With Active Neurofeedback

ConditionsVestibular DisorderVestibular SchwannomaSpace Motion SicknessMotion Sickness
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-70
SponsorJohns Hopkins University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Traditional Therapy

    Behavioral

    Exercises that teaches subjects to move their heads while viewing still or moving targets.

  • SWAN

    Device

    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

Treatment groups

48 Participants
are divided into 4 treatment groups
Group A: Traditional Vestibular Physical Therapy (VPT) JHUActive comparator 1 intervention
Group B: SWAN VPT JHUExperimental treatment 1 intervention
Group C: SWAN Motion Sick DaytonExperimental treatment 1 intervention
Group D: Traditional Motion Sick DaytonNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Daily for up to 4 weeks

Secondary outcomes

1

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.

Time frame
Daily for up to 4 weeks
2

Change in Number of blinks as measured by video-oculography

Increase blinking is correlated with worse motion sickness.

Time frame
Daily for up to 4 weeks
3

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.

Time frame
Daily for up to 4 weeks
4

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.

Time frame
Daily for up to 4 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Johns Hopkins University

Lead sponsor

National Aeronautics and Space Administration (NASA)

Collaborator

Source ClinicalTrials.gov
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