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Vestibular DiseaseNCT04142697

Human Visual and Vestibular Motion Perception Study

A study testing Heading direction adaptation in people with Vestibular Disease, run by University of Rochester at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose this study is to measure sensitivity to visual and vestibular or balance motion. It is hoped that the results may help researchers better understand how aging and disease affect motion perception. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Vestibular Disease
What is being tested?
Heading direction adaptation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteUnited States
Study dates
15 Sep 2020to 1 Sep 2032
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy subjects:
  • general good health
  • Vestibular Disease patients:
  • general good health
  • specific unilateral or bilateral vestibular loss

Who cannot join

  • Healthy subjects:
  • subjects who are institutionalized or otherwise not self-sufficient.
  • enduring sequelae due to diseases of the nervous system, eyes, ears, head and neck, and limbs, except for changes commensurate with normal aging (e.g. presbyacusic hearing loss, mild cataract, etc.).
  • abnormal cognitive function, which if in question can be determined as a score of <27 on the Mini-Mental State test.
  • corrected visual acuity worse than 20/20 up to age 65, worse than 20/40 if >65
  • abnormal binocular stereo-acuity or visual fields.
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  • any defects in cranial nerve, oculomotor, cerebellar/coordination, and somatosensory functions.
  • any abnormal oculomotor and vestibular function (caloric tests)
  • Vestibular Disease patients:
  • Inability to perform the study tasks due to sensory, motor, or postural limitations

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting
  • University of Rochester Medical Center

    Rochester, New York, 14618

    Cesar Arduino, 585-273-2043, Cesar_Arduino@urmc.rochester.edu

    Paul D Allen, PhD, 585-275-1186, paul_allen@urmc.rochester.edu

    Recruiting

Other trials in United States

About this study

Official title: Visual and Vestibular Percepts of Motion

The purpose this study is to measure sensitivity to visual and vestibular or balance motion. It is hoped that the results may help researchers better understand how aging and disease affect motion perception.

Read the detailed description

As people move through natural environments, they experience both visual and inertial stimuli. These can be integrated into a unified perception of self-motion (i.e. common causation) or segregated so that inertial or vestibular stimuli represents self-motion and visual represents external motion. There has been very little work on how causal inference (CI) or determination of common causation occurs for visual and inertial stimuli. Yet this is an important factor in fall risk, motion sickness, simulator sickness, concussion, dementia, and migraine. This proposal aims to develop and establish methods for studying CI in visual and inertial heading perception. This will be used to define the relevant variables in CI for these sensory systems. Common causation is likely a plastic process that occurs when stimuli occur simultaneously. The proposal will also examine this hypothesis by adapting heading perception, which may form the basis for a novel vestibular rehabilitation method.

Aim I: Causal inference (CI) for visual and inertial headings. During natural movements visual and inertial cues occur together. Inertial cues always represent self-motion, visual cues are ambiguous as they can represent motion through a fixed environment, environmental motion relative to the observer, or a combination of both. IA. Techniques for measuring CI for visual and inertial stimuli are not well established. The investigators have developed a technique to measure CI by presenting offset visual and inertial headings simultaneously using a full range of possible directions within the horizontal plane. Subjects report the perceived direction of the visual and inertial stimuli independently and whether or not they share common causation. These trial blocks can be repeated to determine reproducibility. IB. Parameters that influence perception of CI will be varied to determine their relative influences. These parameters will include stimulus timing, duration, and visual field size. It is hypothesized that full-field visual stimuli that are most consistent with the inertial stimulus will be perceived as having common causation. IC. Subjects with unilateral vestibular lesions will be tested using the techniques in IA. These individuals may have increased reliance on visual cues as well as decrease reliability and biases in inertial heading perception. As such, this may cause inertial headings to be more influenced by vision and result in a greater range of common causation.

Aim II: Visual-inertial heading adaptation. Plasticity in vestibular perception has received minimal attention, despite perception being the primary issue in common disorders such as vertigo, motion, and simulator sickness. Better understanding of how adaptation occurs could form the basis for improved therapeutic options as well as better tolerated virtual environments and simulations. IIA. Exposure to visual and inertial headings with similar characteristics, that are systematically offset, will be studied. It is hypothesized that exposure to this situation will influence subsequent visual and inertial heading perception as well as their common causation. These factors will also be measured before and after adaptation. The limits of what types of offsets can induce adaptation, and the range of headings that can be adapted will be explored. IIB. Preliminary data demonstrate that heading adaptation can also be induced by exposure to a virtual environment with an angular velocity offset in the visual stimulus. This method of adaptation will also be studied with regard to its influence on perception of rotation, visual and inertial headings and common causation of these headings. As with IIA, the potential limitations of the method will be explored.

Aim III: Heading adaptation after vestibular loss. Errors in heading perception are a clinically significant problem. Abnormal perception of rotation often quickly normalizes after vestibular lesions, but preliminary data indicate heading perception remains deviated for years afterwards. This could be due to asymmetry in the otolith system which current vestibular rehabilitation methods do not address. Abnormal heading perception may be a significant factor in other disorders including vestibular migraine, dementia, and concussion. Understanding long-term adaptation is potentially important in these populations. IIIA. Time course and etiology of perceptual pathology after acute vestibular lesions is unclear. This will be investigated by sequentially measuring bias and perceptual thresholds of yaw rotation, sway, and heading in individuals with acute loss of vestibular function. Initially subjects have a rotation bias towards the intact side which normalizes over time. The heading bias may correlate with rotational bias or may be related to otolith dysfunction, as measured with sway translation perception, or may occur as a result of adapting to the rotatory vertigo. IIIB. Study of long-term heading adaptation in subjects with chronic unilateral vestibular hypofunction (e.g. those who have had vestibular schwannomas removed, gentamicin ablative therapy for Meniere's disease). Since these subjects often have biased heading perception at baseline, they may be able to exhibit long term adaptation. Heading perception as well as visual-inertial common causation will be measured using the techniques described in Aim IC. Ability to adapt these patients to heading offsets will be measured using the methods established in normal controls (Aim II) but the adaptation will always be in a consistent direction to attempt to normalize baseline deviation in heading perception. It will be determined if durable long-term heading adaptation can be achieved. The proposal aims to understand how visual and inertial cues inform motion perception and how adaptation has the potential to improve pathological perception.

Being tested
Heading direction adaptation
Medical subject headings
Vestibular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Heading direction adaptationBehavioural

    Will adapt subject's perceived heading direction using exposure to visual environments that include rotation and situations where visual and inertial heading direction are systematically offset.

Study groups in NCT04142697
Study groupRoleWhat they receive
Healthy subjectsActive comparatorNot described
Receives: Behavioral: Heading direction adaptation
Vestibular Disease patientsActive comparatorNot described
Receives: Behavioral: Heading direction adaptation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Mean Heading perception

    Heading perception will be measured using two alternative forced choice and magnitude estimation procedures and reported in degrees. It is measured in degrees of azimuth with positive to the right and negative to the left of straight ahead (defined as 0 degrees).

    Measured: Baseline to 1 week

Secondary outcomes (1)
  1. Change in Mean Dizziness Handicap Inventory (DHI)

    The (DHI) will be measured in subjects with unilateral vestibular hypo function to ensure symptoms are not worsening, but will not be measured in health subjects. This is a a 25 question scale ranging from 0-100 with 100 indicating worse dizziness.

    Measured: Baseline to 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2019
  2. Study start15 Sep 2020
  3. Primary completion1 Sep 2030 (estimated)
  4. Study completion1 Sep 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04142697
Sponsor's protocol ID
3911
Other IDs
R01DC013580
Status last verified
Sep 2026
First submitted
21 Oct 2019
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data provided upon request to principal investigator

Questions about this trial

What is this clinical trial studying?

A study testing Heading direction adaptation in people with Vestibular Disease, run by University of Rochester at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Cesar Arduino (585-273-2043, Cesar_Arduino@urmc.rochester.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Mean Heading perception (time frame: Baseline to 1 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

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