Clinical trial NCT06495138: Incremental Vestibulo-ocular Reflex Adaptation As a Novel Treatment for Dizziness in People with Multiple Sclerosis
Official title: Daily Versus Intermittent Incremental Vestibulo-ocular Reflex Adaptation As a Novel Treatment for Dizziness in People with Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Treatment of multiple sclerosis
Incremental Vestibulo-ocular Reflex Adaptation
Dizziness in people with multiple sclerosis
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Multiple Sclerosis Society
First posted: 2024-07-10
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

Detailed 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.

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
* Fluent in speaking and understanding English
* 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
* Benign paroxysmal positional vertigo
* 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

Primary outcomes:
measure: Composite VOR gain (cVOR gain)
timeFrame: Weeks 1,4, 7, and 18
Secondary outcomes:
measure: Best Corrected Dynamic Visual Acuity (During Head Movements)
timeFrame: Weeks 1, 4, 7, and 18
measure: Balance Evaluation Systems Test Total Score
timeFrame: Weeks 1, 4, 7, and 18
measure: Gait Disorientation Test (GDT) Score
timeFrame: Weeks 1, 4, 7, and 18
measure: Dizziness Handicap Inventory Total Score
timeFrame: Weeks 1, 4, 7, and 18
measure: Activities-specific Balance Confidence Scale Average Score
timeFrame: Weeks 1, 4, 7, and 18
measure: Oscillopsia Visual Analog Scale Score
timeFrame: Weeks 1, 4, 7, and 18
measure: Disequilibrium Visual Analog Scale Score
timeFrame: Weeks 1, 4, 7, and 18
measure: Multiple Sclerosis Quality of Life - 54 (MSQOL-54) Total Score
timeFrame: Weeks 1, 4, 7, and 18
measure: Global Perception of Effect Score
timeFrame: Weeks 1, 4, 7, and 18
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Univeristy
state: Georgia
Study officials:
affiliation: Emory University
name: Colin Grove, PT, MS, DPT, PhD
role: PRINCIPAL_INVESTIGATOR
References: