Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 2:43 PM
Study NCT ID:
NCT07380256
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-20
First Post:
2026-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Visual Influences on Vestibular Adaptation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015354', 'term': 'Vision, Low'}], 'ancestors': [{'id': 'D014786', 'term': 'Vision Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': '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'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-18', 'studyFirstSubmitDate': '2026-01-20', 'studyFirstSubmitQcDate': '2026-01-27', 'lastUpdatePostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Vestibulo-Ocular Reflex (VOR) Gain', 'timeFrame': 'Baseline (visit 1) (before and after after IVA intervention), Visit 2 (2-10 days from baseline) (before and after IVA intervention)', 'description': '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.\n\nIVA: Incremental Vestibulo-Ocular Reflex Adaptation'}], 'secondaryOutcomes': [{'measure': 'Change in Modified Clinical Test of Sensory Interaction in Balance (mCTSIB)', 'timeFrame': 'Baseline (visit 1) (before and after after IVA intervention), Visit 2 (2-10 days from baseline) (before and after IVA intervention)', 'description': '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.'}, {'measure': 'Change in Gait Disorientation Test (GDT)', 'timeFrame': 'Baseline (visit 1) (before and after after IVA intervention), Visit 2 (2-10 days from baseline) (before and after IVA intervention)', 'description': '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.'}, {'measure': 'Symptom Severity During IVA (Verbal Analog Scales)', 'timeFrame': 'Baseline (visit 1) (before and after after IVA intervention), Visit 2 (2-10 days from baseline) (before and after IVA intervention)', 'description': '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.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'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'], 'conditions': ['Vestibular Hypofunction', 'Binocular Vision Abnormalities', 'Reduced Vision']}, 'descriptionModule': {'briefSummary': '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.\n\nThe main questions it aims to answer are:\n\n* Does IVA cause only mild, temporary symptoms and no serious adverse events?\n* 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?\n\nResearchers 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.\n\nParticipants will:\n\n* Complete symptom ratings before and after IVA\n* Undergo tests of vestibular reflexes (e.g., VOR gain)\n* Complete balance and walking assessments', 'detailedDescription': "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.\n\nIncremental 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.\n\nThis 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor All Participants (All Groups)\n\n* Age 18 to 60 years\n* Able to provide informed consent\n\nGroup-Specific Inclusion Criteria:\n\n* Group 1: Abnormal Uncorrected Static Visual Acuity (No Vestibular Hypofunction) Normal peripheral vestibular function\n* Group 2: Abnormal Uncorrected Static Visual Acuity + peripheral Vestibular Hypofunction\n* Group 3: Binocular Vision Abnormalities (No Vestibular Hypofunction) Normal peripheral vestibular function\n* Group 4: Binocular Vision Abnormalities + peripheral Vestibular Hypofunction\n\nIndividuals who have abnormal static visual acuity, a binocular vision abnormality (ocular misalignment, convergence insufficiency), and vestibular loss will be assigned to Group 4.\n\nThe following definitions will be used when determining group placement:\n\n* Abnormal Static Visual Acuity: Uncorrected visual acuity (head is still) ≥0.30 logMAR in both eyes.\n* Unilateral Vestibular Hypofunction: 60 ms VOR gain \\<0.80 unilaterally for the lateral semicircular canal.\n* Bilateral Vestibular Hypofunction: 60 ms VOR gain \\<0.80 bilaterally for the lateral semicircular canals.\n* Normal Vestibular Function: 60 ms VOR gain of 0.80 to 1.20 bilaterally for the lateral semicircular canals.\n* Convergence Insufficiency: ≥6 cm near point of convergence.\n* Ocular Misalignment: ≥4 prism diopters of manifest deviation of the eyes (tropia) on cover/uncover testing.\n\nExclusion Criteria:\n\n* Diagnosis of fluctuating vestibular disorders (e.g., benign paroxysmal positional vertigo)\n* Neurologic conditions (e.g., multiple sclerosis), dementia,\n* Alcohol or drug abuse,\n* A major psychiatric disorder (e.g., schizophrenia),\n* Pain that limits cervical spine range of motion by \\>50% or that results in an -altered gait pattern.'}, 'identificationModule': {'nctId': 'NCT07380256', 'briefTitle': 'Visual Influences on Vestibular Adaptation', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'Effects of Impaired Visual Acuity and Binocular Control Abnormalities (VABC) on Vestibulo-ocular Reflex (VOR) Adaptation in Adults With and Without Vestibular Hypofunction', 'orgStudyIdInfo': {'id': '2025P012555'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1: Abnormal Uncorrected Static Visual Acuity (No Vestibular Hypofunction)', 'description': 'Adults with abnormal uncorrected distance visual acuity and normal vestibular function.\n\nThis 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).\n\nExperiment 1 tests the effect of blurry vision on VOR adaptation', 'interventionNames': ['Device: StableEyes: Incremental Vestibulo-Ocular Reflex Adaptation (IVA)']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2: Abnormal Uncorrected Static Visual Acuity + Vestibular Hypofunction', 'description': 'Adults with abnormal uncorrected distance visual acuity and unilateral vestibular hypofunction.\n\nThis 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).\n\nExperiment 1 tests the effect of blurry vision on VOR adaptation', 'interventionNames': ['Device: StableEyes: Incremental Vestibulo-Ocular Reflex Adaptation (IVA)']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3: Binocular Vision Abnormalities (No Vestibular Hypofunction)', 'description': 'Adults with binocular vision abnormalities (e.g., convergence insufficiency, ocular misalignment) and normal vestibular function.\n\nThis 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).\n\nExperiment 2 tests the effect of binocular vision dysfunction on VOR adaptation', 'interventionNames': ['Device: StableEyes: Incremental Vestibulo-Ocular Reflex Adaptation (IVA)']}, {'type': 'EXPERIMENTAL', 'label': 'Group 4: Binocular Vision Abnormalities + Vestibular Hypofunction', 'description': 'Adults with binocular vision abnormalities and unilateral vestibular hypofunction.\n\nThis 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).\n\nExperiment 2 tests the effect of binocular vision dysfunction on VOR adaptation', 'interventionNames': ['Device: StableEyes: Incremental Vestibulo-Ocular Reflex Adaptation (IVA)']}], 'interventions': [{'name': 'StableEyes: Incremental Vestibulo-Ocular Reflex Adaptation (IVA)', 'type': 'DEVICE', 'description': "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.", 'armGroupLabels': ['Group 1: Abnormal Uncorrected Static Visual Acuity (No Vestibular Hypofunction)', 'Group 2: Abnormal Uncorrected Static Visual Acuity + Vestibular Hypofunction', 'Group 3: Binocular Vision Abnormalities (No Vestibular Hypofunction)', 'Group 4: Binocular Vision Abnormalities + Vestibular Hypofunction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'contacts': [{'name': 'Jason Peragallo, MD', 'role': 'CONTACT'}, {'name': 'Hannah Morris', 'role': 'CONTACT', 'email': 'hannah.m.morris@emory.edu'}, {'name': 'David Sandlin, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Emory Ophthalmology Clinics', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30329', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'contacts': [{'name': 'Colin Grove, PT, DPT, PhD', 'role': 'CONTACT', 'email': 'colin.r.grove@emory.edu', 'phone': '404-712-8685'}, {'name': 'David Sandlin, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Colin Grove, PT, DPT, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dizziness and Balance Center', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'centralContacts': [{'name': 'Colin R Grove, PT,DPT,PhD', 'role': 'CONTACT', 'email': 'colin.riess.grove@emory.edu', 'phone': '(404) 712-8685'}, {'name': 'Hannah M Morris', 'role': 'CONTACT', 'email': 'hannah.m.morris@emory.edu'}], 'overallOfficials': [{'name': 'Colin Grove, PT, DPT, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': '12 months after the primary outcome is published; indefinitely', 'ipdSharing': 'YES', 'description': 'A complete de-identified dataset will be shared.', 'accessCriteria': 'Mechanism: Through the Open Science Framework or Emroy Dataverse'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Colin R. Grove', 'investigatorAffiliation': 'Emory University'}}}}