Sensory Training for Visual Motion Sickness

NCT04420949 | Completed Results

• 5 other identifiers: 2020-0632A176000EDUC/KINESIOLOGYProtocol Version 5/1/20201UL1TR002373-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This is a preliminary study to determine the reliability and validity of new tests of orientation and balance, as well as to test the effects of a new treatment for visually induced dizziness. Tests involve determining vertical alignment. The treatment is task-based and involves focusing attention on internal body sensations to help improve the sense of upright. Testing is done twice before and twice after treatment, which is provided twice-weekly during a three-week period between testing. The total time participants are involved in the study is approximately six weeks.

Conditions

Dizziness; Vertigo; Motion Sickness

Keywords

verticality; postural balance; visual dependence

Outcome Measures

Primary Outcomes (4)

• Rod and Disk Test (RDT) Mean Performance

  An image of a rod will be shown in the central portion of the visual field. The surrounding virtual environment will be void. A batch of rod angles will be predetermined. This assessment will be completed using an Oculus Rift and without any reference to external visual cues. Only binocular testing will be completed. The average value for performance in each position will be used in data analysis. The mean of absolute value of the error in rod alignment measured in degrees for each body position tested will be used as the measurement variable for this outcome, and the primary outcome is the absolute value for mean performance in upright. In a prior study, the mean performance in this population is 0.39 (sd 0.8). Higher scores indicate subjective visual vertical alignment that is farther away from earth vertical.

  Visit 1 (Week 1), Visit 2 (Week 2), Visit 7 (Week 4), and Visit 8 (Week 5)

• Multisensory Balance Evaluation (MBE) as Measured by the Intersection Point Height

  This test is designed to assess balance during quiet standing in different sensory conditions. Participants perform one trial (lasting 30 seconds) of each condition. All trials are performed while standing on a force plate with the feet in a self-selected, comfortable position. The visual environment is controlled using an Oculus Rift. The surface conditions are either non-compliant or compliant. The frequency-dependent height of the Intersection Point (IP) of the ground reaction force is the main metric. The overall height of the IP curve obtained while the participant stands on a firm surface with their eyes open is the primary outcome. The height of IP ranges from 0 to 4.0, and higher values represent greater stability.

  Visit 1 (Week 1), Visit 2 (Week 2), Visit 7 (Week 4), and Visit 8 (Week 5)

• Subjective Visual Vertical (SVV) Mean Performance

  An image of a rod will be shown in the central portion of the visual field. The surrounding virtual environment will be void. A batch of rod angles will be predetermined. This assessment will be completed using an Oculus Rift and without any reference to external visual cues. Only binocular testing will be completed. The average value for performance in each position will be used in data analysis. The mean of absolute value of the error in rod alignment measured in degrees for each body position tested will be used as the measurement variable for this outcome, and the primary outcome is the absolute value for mean performance in upright. In a prior study, the mean performance in this population is 0.39 (sd 0.8). Higher scores indicate subjective visual vertical alignment that is farther away from earth vertical.

  Visit 1 (Week 1), Visit 2 (Week 2), Visit 7 (Week 4), and Visit 8 (Week 5)

• Rod and Frame Test (RFT) Mean Performance

  An image of a rod will be projected inside a tilted frame within the central portion of the visual field. The surrounding virtual environment will be void. The frame will be tilted by +/- 20° in the frontal plane. A batch of rod angles will be predetermined. This assessment will be completed using an Oculus Rift and without reference to external visual cues. Only binocular testing will be completed. The average value for performance in each position will be used in data analysis. The mean of absolute value of the error in rod alignment measured in degrees for each body position tested will be used as the measurement variable for this outcome, and the primary outcome is the absolute value for mean performance in upright. In a prior study, mean performance in this population is 6.51 (sd 7.8). Higher values indicate greater deviations of perceived vertical from earth vertical.

  Visit 1 (Week 1), Visit 2 (Week 2), Visit 7 (Week 4), and Visit 8 (Week 5)

Secondary Outcomes (2)

• Vision-related Dizziness Questionnaire (VRDQ) Total Score

  Visit 1 (Week 1), Visit 2 (Week 2), Visit 7 (Week 4), and Visit 8 (Week 5)

• Dizziness Handicap Inventory (DHI) Total Score

  Visit 1 (Week 1), Visit 2 (Week 2), Visit 7 (Week 4), and Visit 8 (Week 5)

Other Outcomes (5)

• Activities-specific Balance Confidence Scale (ABCS) Average Score

  Visit 1 (Week 1), Visit 2 (Week 2), Visit 7 (Week 4), and Visit 8 (Week 5)

• Vestibular Activities and Participation Measure (VAPM) Average Score

  Visit 1 (Week 1) and Visit 8 (Week 5)

• Vestibular Rehabilitation Benefits Questionnaire (VRBQ) Total Score at the End of the Trial

  Visit 1 (Week 1) and Visit 8 (Week 5)

Study Arms (2)

Healthy

EXPERIMENTAL

Healthy adults with visually-induced dizziness with undergo the testing and treatment.

Behavioral: Sensory re-weighting

Vestibular-impaired

EXPERIMENTAL

Adults with unilateral or bilateral, peripheral vestibular loss who also have visually-induced dizziness with undergo the testing and treatment.

Behavioral: Sensory re-weighting

Interventions

Sensory re-weighting BEHAVIORAL

During training, sensory re-weighting is driven by priming upregulation of somatosensory cues. Two rounds of training, each lasting 15 minutes and block-randomized in sets of 10 trials, are conducted per training visit. In each training trial, participants must determine the direction of gravity and then indicate if the rod being displayed is aligned with gravity or if it needs to rotate clockwise or counterclockwise for that to be so. Participants will be instructed to pay attention to what they feel from their feet, legs, and gut during training and to use that pressure, stretch, movement, and muscle tension feedback to help them sense gravity. Immediate auditory and non-orienting, visual feedback is provided after each trial. A staircase method is used to adapt the level of difficulty based on response accuracy. After two consecutive correct responses, the difficulty increases. After each incorrect response, the difficulty decreases. This process is repeated in each round.

Healthy; Vestibular-impaired

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• have normal self-reported cognitive function
• speak English fluently
• weigh less than 225 pounds and be less than 6'4"
• be able to support their body weight in an upright posture for 15 minutes at a time
• be able to follow the guidelines regarding permitted and prohibited additional treatments outlined in this protocol

You may not qualify if:

• be pregnant or planning to become pregnant while in "on study" status
• have best-corrected visual acuity \> 20/70
• have a self-reported, uncompensated, binocular vision abnormality, such as strabismus, amblyopia, or diplopia
• have peripheral neuropathy
• have a self-reported history of frequent syncope (\>1/month)
• Participants with Visually-induced Dizziness:
• have self-reported symptoms of visually-induced dizziness
• have normal self-reported cognitive function
• speak English fluently
• weigh less than 225 pounds and be less than 6'4"
• be able to support their body weight in an upright posture for 15 minutes at a time
• be able to follow the guidelines regarding permitted and prohibited additional treatments outlined in this protocol
• be participating in vestibular and balance rehabilitation therapy and/or be pregnant or planning to become pregnant while in "on study" status
• have best-corrected visual acuity \> 20/70
• have a self-reported, uncompensated, binocular vision abnormality, such as strabismus, amblyopia, or diplopia

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

University of Wisconsin-Madison

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Dizziness; Vertigo; Motion Sickness

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Nervous System Diseases

Limitations and Caveats

Due to Covid-19 restrictions, enrollment in this study was lower than planned.

Results Point of Contact

• Title: Dr. Kreg Gruben
• Organization: University of Wisconsin - Madison

kreg.gruben@wisc.edu

608 262 2711

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: It is not possible to mask this behavioral intervention. The study team small; thus, masking of the study team is also not possible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will be conducted in three phases. The first phase is for baseline testing. The second phase is when treatment occurs. The third phase is for follow up testing. Participants will be tested twice during the baseline and follow up phases. Six treatment sessions will occur during the treatment phase.

Study Record Dates

• First Submitted: May 15, 2020
• First Posted: June 9, 2020
• Study Start: March 19, 2021
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: June 15, 2023
• Results First Posted: January 25, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)