Recruiting

Vestibulo-ocular Reflex Adaptation

Sponsor:

Emory University

Code:

NCT06495138

Conditions

Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

StableEyes

Study Details

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

Study ID

NCT06495138

Start date

Apr 21, 2025

Status verified date

Jul, 2025

Completion date

Mar, 2027

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

138 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

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.

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

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.

no intervention: Helathy Control

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

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.

Primary outcome measure

  • Composite VOR gain (cVOR gain) [ Time Frame: Weeks 0,1,2,3,4,5,6, 7, and 18 ]

Central Contacts and Locations

Central contacts

Colin Grove, PT, DPT, MS, PhD

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

Colin Grove

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

Locations

Emory Univeristy

Recruiting

Atlanta, Georgia, United States, 30329

More Information

Sponsor

Emory University

Last update posted

Jul 16, 2025

Last verified

Jul, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2025-07-16.