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Recruiting NCT05622344

StableEyes With Active Neurofeedback

No phase Interventional Vestibular Disorder Vestibular Schwannoma Space Motion Sickness Motion Sickness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Traditional Therapy, SWAN.
Who it may be relevant to
Registry conditions: Vestibular Disorder, Vestibular Schwannoma, Space Motion Sickness, Motion Sickness. Basic parameters: 21 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

StableEyes With Active Neurophysiological Feedback

Overview

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.

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

Primary outcome measures

  • Change in Motion sickness intensity as assessed by subjective rating [Time frame: Daily for up to 4 weeks]
Secondary outcome measures (12)
  • Change in Vestibulo-Ocular Reflex (VOR) gain as measured by video-oculography [Time frame: Daily for up to 4 weeks]
  • Change in Number of blinks as measured by video-oculography [Time frame: Daily for up to 4 weeks]
  • Change in Heart rate as measured by a monitor worn over the forearm [Time frame: Daily for up to 4 weeks]
  • Change in Timed Up and Go Plus [Time frame: Daily for up to 4 weeks]
  • Change in Foam Stance - Eyes Open [Time frame: Daily for up to 4 weeks]
  • Change in Foam Stance - Eyes Closed [Time frame: Daily for up to 4 weeks]
  • Change in Foam Stance - Eyes Open with head motion [Time frame: Daily for up to 4 weeks]
  • Change in Foam Stance - Eyes Closed with head motion [Time frame: Daily for up to 4 weeks]
  • Change in Gait speed [Time frame: Daily for up to 4 weeks]
  • Change in Gait endurance [Time frame: Daily for up to 4 weeks]
  • Change in Vertical and torsional alignment nulling test (VAN and TAN) [Time frame: Daily for up to 4 weeks]
  • Change in Rod and Frame Test [Time frame: Daily for up to 4 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 2 centers
  • Johns Hopkins University — Baltimore
  • Naval Medical Research Unit — Dayton

Publications

  • 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. PMID 36075099

Identifiers

NCT: NCT05622344 · IRB00281972 · 80NSSC21M0057

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗