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

NCT06495138 · Emory University
In plain English

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Official title
Daily Versus Intermittent Incremental Vestibulo-ocular Reflex Adaptation as a Novel Treatment for Dizziness in People With Multiple Sclerosis
About this study
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.
Eligibility criteria
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 target: 138 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2025-04-21
Estimated completion: 2027-03
Last updated: 2025-07-16
Interventions
Device: StableEyes
Primary outcomes
  • Composite VOR gain (cVOR gain) (Weeks 0,1,2,3,4,5,6, 7, and 18)
Sponsor
Emory University · other
With: National Multiple Sclerosis Society
Contacts & investigators
ContactColin Grove, PT, DPT, MS, PhD · contact · colin.r.grove@emory.edu · (404) 712-8685
ContactColin Grove · contact · colin.r.grove@emory.edu · (404) 712-8685
InvestigatorColin Grove, PT, MS, DPT, PhD · principal_investigator, Emory University
All locations (1)
Emory UniveristyRecruiting
Atlanta, Georgia, United States
Incremental Vestibulo-ocular Reflex Adaptation as a Novel Treatment for Dizziness in People With Multiple Sclerosis · TrialPath