AzTrials
AzTrials

Vestibular HypofunctionNCT07380256

Visual Influences on Vestibular Adaptation

A study testing StableEyes: Incremental Vestibulo-Ocular Reflex Adaptation (IVA) in people with Vestibular Hypofunction and Binocular Vision Abnormalities, run by Emory University at 2 sites 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
Search all trials

Trial summary

The goal of this study is to learn whether a balance-training exercise called incremental vestibulo-ocular reflex adaptation (IVA) is safe and effective for adults with vision impairments, with or without additional vestibular (inner-ear balance) problems. Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
StableEyes: Incremental Vestibulo-Ocular Reflex Adaptation (IVA)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
2 sitesUnited States
Study dates
4 Feb 2026to Dec 2029
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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • For All Participants (All Groups)
  • Age 18 to 60 years
  • Able to provide informed consent
  • Group-Specific Inclusion Criteria:
  • Group 1: Abnormal Uncorrected Static Visual Acuity (No Vestibular Hypofunction) Normal peripheral vestibular function
  • Group 2: Abnormal Uncorrected Static Visual Acuity + peripheral Vestibular Hypofunction
Show all 16Show fewer
  • Group 3: Binocular Vision Abnormalities (No Vestibular Hypofunction) Normal peripheral vestibular function
  • Group 4: Binocular Vision Abnormalities + peripheral Vestibular Hypofunction
  • Individuals who have abnormal static visual acuity, a binocular vision abnormality (ocular misalignment, convergence insufficiency), and vestibular loss will be assigned to Group 4.
  • The following definitions will be used when determining group placement:
  • Abnormal Static Visual Acuity: Uncorrected visual acuity (head is still) ≥0.30 logMAR in both eyes.
  • Unilateral Vestibular Hypofunction: 60 ms VOR gain <0.80 unilaterally for the lateral semicircular canal.
  • Bilateral Vestibular Hypofunction: 60 ms VOR gain <0.80 bilaterally for the lateral semicircular canals.
  • Normal Vestibular Function: 60 ms VOR gain of 0.80 to 1.20 bilaterally for the lateral semicircular canals.
  • Convergence Insufficiency: ≥6 cm near point of convergence.
  • Ocular Misalignment: ≥4 prism diopters of manifest deviation of the eyes (tropia) on cover/uncover testing.

Who cannot join

  • Diagnosis of fluctuating vestibular disorders (e.g., benign paroxysmal positional vertigo)
  • Neurologic conditions (e.g., multiple sclerosis), dementia,
  • Alcohol or drug abuse,
  • A major psychiatric disorder (e.g., schizophrenia),
  • Pain that limits cervical spine range of motion by >50% or that results in an -altered gait pattern.

Trial locations and contacts

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

Colin R Grove, PT,DPT,PhD contact

(404) 712-8685

colin.riess.grove@emory.edu

Hannah M Morris contact

hannah.m.morris@emory.edu

United States2 sites, 2 recruiting
  • Emory Ophthalmology Clinics

    Atlanta, Georgia, 30322

    Jason Peragallo, MD

    Hannah Morris, hannah.m.morris@emory.edu

    Not yet recruiting
  • Dizziness and Balance Center

    Atlanta, Georgia, 30329

    Colin Grove, PT, DPT, PhD, 404-712-8685, colin.r.grove@emory.edu

    David Sandlin, MD

    Recruiting

Other trials in United States

About this study

Official title: Effects of Impaired Visual Acuity and Binocular Control Abnormalities (VABC) on Vestibulo-ocular Reflex (VOR) Adaptation in Adults With and Without Vestibular Hypofunction

The goal of this study is to learn whether a balance-training exercise called incremental vestibulo-ocular reflex adaptation (IVA) is safe and effective for adults with vision impairments, with or without additional vestibular (inner-ear balance) problems.

The main questions it aims to answer are:

Read more
  • Does IVA cause only mild, temporary symptoms and no serious adverse events?
  • Does IVA improve eye-movement reflexes, balance, and walking, and do these improvements differ between people with vision problems alone and those with both vision and vestibular impairments?

Researchers will compare adults with vision impairment only to adults who have both vision and vestibular impairments to see whether the groups respond differently to IVA.

Participants will:

  • Complete symptom ratings before and after IVA
  • Undergo tests of vestibular reflexes (e.g., VOR gain)
  • Complete balance and walking assessments
Read the detailed description

Impairment of vestibular pathways can lead to deficits in balance, gait, and gaze stability. Gaze-stability exercises are a central component of vestibular rehabilitation and have been shown to improve vision during head movement as well as functional mobility in individuals with peripheral or central vestibular dysfunction. Improvements in gaze stability may occur through vestibulo-ocular reflex (VOR) adaptation or through compensatory saccadic eye movements. However, many adults with vestibular hypofunction also present with uncorrected visual acuity deficits or binocular vision abnormalities, such as low vision, convergence insufficiency, or ocular misalignment. These visual conditions are common but understudied in the context of vestibular rehabilitation, and it is not known whether they limit the capacity for VOR adaptation.

Incremental vestibulo-ocular reflex adaptation (IVA) is a non-invasive, 15-minute training method that strengthens the VOR by exposing users to a controlled visual error signal. IVA uses a moving laser target whose velocity is programmed as a function of the participant's head movement, producing immediate increases in VOR gain. The method can be customized to provide unilateral, bilateral, or asymmetric adaptation, allowing targeted training for individuals with unilateral or bilateral vestibular deficits. IVA has been studied extensively in adults with vestibular hypofunction, but its effectiveness in individuals with impaired visual acuity or binocular vision abnormalities has not been evaluated.

This study will examine whether reduced static visual acuity or binocular vision abnormalities affect the magnitude of VOR adaptation in adults with and without vestibular hypofunction. Two experiments will be conducted using a cross-over design. Experiment 1 will enroll adults with abnormal uncorrected static visual acuity, with and withoutvestibular hypofunction, to compare VOR adaptation with and without vision correction. Experiment 2 will enroll adults with binocular vision abnormalities, with and without vestibular hypofunction, to evaluate VOR adaptation in their best corrected visual state. All participants will complete IVA training during two study visits separated by a washout period.

Being tested
StableEyes: Incremental Vestibulo-Ocular Reflex Adaptation (IVA)
Keywords
vestibulo-ocular reflex, incremental vestibulo-ocular reflex adaptation, abnormal uncorrected static visual acuity, Gait Disorientation Test, video head impulse test, vertical and torsional alignment nulling, dynamic visual acuity test, modified Clinical Test of Sensory Interaction in Balance
Medical subject headings
Vision, Low

What participants receive

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

  • StableEyes: Incremental Vestibulo-Ocular Reflex Adaptation (IVA)Device

    IVA is delivered using the StableEyes device, which includes a lightweight head-mounted unit with inertial sensors and a micromirror that controls the position of a low-power laser target projected onto a wall. The device adjusts the target's movement based on the participant's head velocity to create a controlled visual error signal that induces vestibulo-ocular reflex (VOR) adaptation. During each session, participants sit about one meter from a blank wall and perform rapid, self-generated head impulses while visually tracking the moving laser target. The target appears at neutral, moves at a fraction of head velocity during each impulse, and briefly disappears before reappearing at center. Each session lasts 15 minutes and includes roughly 150 head impulses in the horizontal or vertical plane. The procedure has been well-tolerated in prior studies with no reported adverse events.

Study groups in NCT07380256
Study groupRoleWhat they receive
Group 1: Abnormal Uncorrected Static Visual Acuity (No Vestibular Hypofunction)ExperimentalAdults with abnormal uncorrected distance visual acuity and normal vestibular function. This group will be part of Experiment 1. This experiment studies people whose main visual problem is reduced uncorrected distance visual acuity (i.e., blurry vision without glasses/contacts). Experiment 1 tests the effect of blurry vision on VOR adaptation
Receives: Device: StableEyes: Incremental Vestibulo-Ocular Reflex Adaptation (IVA)
Group 2: Abnormal Uncorrected Static Visual Acuity + Vestibular HypofunctionExperimentalAdults with abnormal uncorrected distance visual acuity and unilateral vestibular hypofunction. This group will be part of Experiment 1. This experiment studies people whose main visual problem is reduced uncorrected distance visual acuity (i.e., blurry vision without glasses/contacts). Experiment 1 tests the effect of blurry vision on VOR adaptation
Receives: Device: StableEyes: Incremental Vestibulo-Ocular Reflex Adaptation (IVA)
Group 3: Binocular Vision Abnormalities (No Vestibular Hypofunction)ExperimentalAdults with binocular vision abnormalities (e.g., convergence insufficiency, ocular misalignment) and normal vestibular function. This group will be part of Experiment 2. This experiment studies people whose main visual problem is how the two eyes work together (e.g., convergence insufficiency, ocular misalignment). Experiment 2 tests the effect of binocular vision dysfunction on VOR adaptation
Receives: Device: StableEyes: Incremental Vestibulo-Ocular Reflex Adaptation (IVA)
Group 4: Binocular Vision Abnormalities + Vestibular HypofunctionExperimentalAdults with binocular vision abnormalities and unilateral vestibular hypofunction. This group will be part of Experiment 2. This experiment studies people whose main visual problem is how the two eyes work together (e.g., convergence insufficiency, ocular misalignment). Experiment 2 tests the effect of binocular vision dysfunction on VOR adaptation
Receives: Device: StableEyes: Incremental Vestibulo-Ocular Reflex Adaptation (IVA)

What is being measured

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

  1. Change in Vestibulo-Ocular Reflex (VOR) Gain

    VOR gain will be measured using the video head impulse test (vHIT). Gain is calculated as eye velocity divided by head velocity during high-acceleration, moderate velocity, small amplitude head rotations in the plane of the semicircular canals. This outcome quantifies the strength of the vestibulo-ocular reflex, with higher gain values indicating stronger VOR responses, with normal gain = 0.8 to 1.2. The change in VOR gain from before to after training will be used to assess VOR adaptation.

    IVA: Incremental Vestibulo-Ocular Reflex Adaptation

    Measured: Baseline (visit 1) (before and after after IVA intervention), Visit 2 (2-10 days from baseline) (before and after IVA intervention)

Secondary outcomes (3)
  1. Change in Modified Clinical Test of Sensory Interaction in Balance (mCTSIB)

    Participants stand under four sensory conditions (eyes open/closed on firm/foam surfaces). Outcomes include time maintained (0-120 seconds) and postural sway metrics from inertial measurement units. Higher times indicate better balance.

    Measured: Baseline (visit 1) (before and after after IVA intervention), Visit 2 (2-10 days from baseline) (before and after IVA intervention)

  2. Change in Gait Disorientation Test (GDT)

    Participants walk 20 feet with eyes open and eyes closed. The GDT score is the difference in time between the two conditions. Larger differences indicate greater gait disorientation.

    Measured: Baseline (visit 1) (before and after after IVA intervention), Visit 2 (2-10 days from baseline) (before and after IVA intervention)

  3. Symptom Severity During IVA (Verbal Analog Scales)

    Symptom tolerance during incremental VOR adaptation (IVA) will be assessed using verbal analog scales. Participants will rate the severity of blurry vision, eye strain, dizziness, and headache on 0-10 scales, where 0 indicates no symptoms and 10 indicates the worst imaginable symptoms. Ratings will be collected immediately before and after each IVA session to quantify changes in self-reported symptom severity.

    Measured: Baseline (visit 1) (before and after after IVA intervention), Visit 2 (2-10 days from baseline) (before and after IVA intervention)

Timeline

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

  1. First posted2 Feb 2026
  2. Study start4 Feb 2026
  3. Primary completionDec 2029 (estimated)
  4. Study completionDec 2029 (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
Randomised
Intervention model
Crossover
Model description
Participants will be randomized for the vision condition (with or without correction) in which they will perform IVA during the first study visit. At the second study visit, all participants will cross over to perform IVA in the opposite vision condition
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07380256
Sponsor's protocol ID
2025P012555
Status last verified
Apr 2026
First submitted
20 Jan 2026
Last updated
17 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: A complete de-identified dataset will be shared.

Questions about this trial

What is this clinical trial studying?

A study testing StableEyes: Incremental Vestibulo-Ocular Reflex Adaptation (IVA) in people with Vestibular Hypofunction and Binocular Vision Abnormalities, run by Emory University at 2 sites 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 16 inclusion and 5 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 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 Colin R Grove, PT,DPT,PhD ((404) 712-8685, colin.riess.grove@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Vestibulo-Ocular Reflex (VOR) Gain (time frame: Baseline (visit 1) (before and after after IVA intervention), Visit 2 (2-10 days from baseline) (before and after IVA intervention)). 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 17 Apr 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in