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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-21

Study Completion Date

2027-03-31

Brief Summary

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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.

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Detailed Description

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People with multiple sclerosis (MS) often experience dizziness, caused by problems in how their brain processes balance signals. This dizziness can lead to difficulties keeping their eyes focused on a target while moving their head, known as gaze instability. This makes activities like walking or driving challenging and dangerous. Vestibular physical therapy, including gaze stabilization exercises, can help. The team developed StableEyes, a technology that improves gaze stability using a gradual approach to these exercises. In the studies, StableEyes significantly enhanced gaze stability in people with balance issues. Preliminary research in people with MS shows promising results, suggesting that tailored gaze stability exercises can further improve their vision stability. This method targets the vestibulo-ocular reflex (VOR), a critical reflex for maintaining clear vision during head movements. Improved VOR function can reduce dizziness and improve the quality of life for people with MS.

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

StableEyes

Intervention Type 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.

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.

Group Type EXPERIMENTAL

StableEyes

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes