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

Emory University

Status: Enrolling

Conditions: Multiple Sclerosis

Treatments: Device: StableEyes

Study type: Interventional

Funder types: Other

Identifiers

NCT06495138

STUDY00007558

RG-2307-41945 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 138 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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138 participants in 3 patient groups

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

Experimental group

Description:

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.

Treatment:

Device: StableEyes

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

Experimental group

Description:

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.

Treatment:

Device: StableEyes

Helathy Control

No Intervention group

Description:

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.