Incremental Vestibulo-ocular Reflex Adaptation as a Novel Treatment for Dizziness in People With Multiple Sclerosis

NCT06495138 | Recruiting FDA Device

• 2 other identifiers: STUDY00007558RG-2307-41945
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to study the effects of a novel treatment for vestibular symptoms in people with multiple sclerosis. The main objective is to determine whether daily personalized gaze stabilization training is more beneficial than intermittent gaze stability training in people with multiple sclerosis.

Conditions

Multiple Sclerosis

Keywords

Treatment of multiple sclerosis; Incremental Vestibulo-ocular Reflex Adaptation; Dizziness in people with multiple sclerosis

Outcome Measures

Primary Outcomes (1)

• Composite VOR gain (cVOR gain)

  The team will conduct the video head impulse test (vHIT), a physiologic assay of vestibular semicircular canal pathway function. Angular vestibulo-ocular reflex gain will be calculated as eye velocity / head velocity during self-generated and/or passive high frequency head rotations which will be conducted in the yaw, pitch, roll, and/or semicircular canal planes.

  Weeks 0,1,2,3,4,5,6, 7, and 18

Secondary Outcomes (9)

• Best Corrected Dynamic Visual Acuity (During Head Movements)

  Weeks 0,1, 4, 7, and 18

• Balance Evaluation Systems Test Total Score

  Weeks 1, 4, 7, and 18

• Gait Disorientation Test (GDT) Score

  Weeks 1, 4, 7, and 18

• Dizziness Handicap Inventory Total Score

  Weeks 1, 4, 7, and 18

• Activities-specific Balance Confidence Scale Average Score

  Weeks 1, 4, 7, and 18

Study Arms (3)

Daily Incremental Vestibulo-ocular Reflex Adaptation (D-IVA-GSE)

EXPERIMENTAL

The dosages of the D-IVA-GSE and I-IVA-GSE are based on the FITT principle of exercise prescription (frequency, intensity, time, and type). The D-IVA-GSE group will perform two, 15- minute GSE sessions (30-minutes total per day), seven days per week.

Device: StableEyes

Intermittent incremental vestibulo-ocular Reflex Adaptation (I-IVA-GSE)

EXPERIMENTAL

The I-IVA-GSE group will perform two, 15-minute IVA-GSE sessions (30 minutes total), three days per week, with at least one day between each exercise day.

Device: StableEyes

Helathy Control

NO INTERVENTION

The healthy control group will complete the same baseline assessments as the subjects in the Multiple Sclerosis (MS) group to serve as normative reference data.

Interventions

StableEyes DEVICE

Gaze stabilization exercises using the StableEyes device for the incremental vestibular-ocular reflex adaptation approach. The StableEyes device consists of a lightweight head unit with a 9-dimension inertial measurement unit and electrostatic micro-mirror that dynamically controls the 2-dimensional position of a 1-milliwatt red laser projected on a wall 1 meter in front of the subject. StableEyes is controlled via a lightweight control unit with a touchscreen interface tethered by cable to the head unit.

Daily Incremental Vestibulo-ocular Reflex Adaptation (D-IVA-GSE); Intermittent incremental vestibulo-ocular Reflex Adaptation (I-IVA-GSE)

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Neurologist-confirmed diagnosis of primary progressive or relapsing and remitting MS per The 2017 Revision of the McDonald Criteria and the Magnetic Resonance Imaging in MS, or a healthy volunteer without a diagnosis of multiple sclerosis or any related neurological conditions
• Fluent in speaking and understanding English
• Subjects with multiple sclerosis have self-reported vestibular symptoms of dizziness, imbalance, and/or a history of at least two falls in the prior 12 months

You may not qualify if:

• Clinically isolated syndrome or radiologically isolated syndrome.
• Worsening MS symptoms during the prior 60 days
• Immunotherapy change in the prior 60 days
• Self-reported cognitive impairment that limits independence with basic and instrumental activities of daily living
• Systolic blood pressure \> 180 mmHg and/or diastolic blood pressure \> 90 mmHg at rest
• Static visual acuity with correction of worse than 1.0 logMAR
• Manifest ocular misalignment ≥ 5 diopters (e.g., tropia, lazy eye, strabismus}
• Convergence insufficiency
• Intra-nuclear ophthalmoplegia
• Vestibular Migraine
• Major orthopedic conditions that limit cervical spine range of motion or that alter walking
• Self-reported current or potential for pregnancy during enrollment
• Ongoing participation in vestibular rehabilitation for dizziness

Sponsors & Collaborators

• Emory University: lead
• National Multiple Sclerosis Society: collaborator

Study Sites (1)

Emory Univeristy

Atlanta, Georgia, 30329, United States

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Colin Grove, PT, MS, DPT, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Colin Grove, PT, DPT, MS, PhD

CONTACT

(404) 712-8685; colin.r.grove@emory.edu

Colin Grove

CONTACT

(404) 712-8685; colin.r.grove@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Subjects will be block-randomized to one of two treatment groups. These groups will be stratified based on the region(s) of central nervous system involvement as determined by participants' Functional System Scores. During the six-week intervention phase, StableEyes will deliver either D-IVA-GSE or I-VA-GSE to participants based on their randomization results.

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 10, 2024
• Study Start: April 21, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: July 16, 2025

Record last verified: 2025-07

Locations

US (1)