Daily Versus Intermittent Incremental Vestibulo-ocular Reflex Adaptation as a Novel Treatment for Dizziness in People With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 138
- 试验地点
- 2
- 主要终点
- Composite VOR gain (cVOR gain)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Composite VOR gain (cVOR gain)
时间窗: Weeks 0,1,2,3,4,5,6, 7, and 18
The team will conduct the video head impulse test (vHIT), a physiologic assay of vestibular semicircular canal pathway function. Angular vestibulo-ocular reflex gain will be calculated as eye velocity / head velocity during self-generated and/or passive high frequency head rotations which will be conducted in the yaw, pitch, roll, and/or semicircular canal planes.
次要结局
- Best Corrected Dynamic Visual Acuity (During Head Movements)(Weeks 0,1, 4, 7, and 18)
- Balance Evaluation Systems Test Total Score(Weeks 1, 4, 7, and 18)
- Activities-specific Balance Confidence Scale Average Score(Weeks 1, 4, 7, and 18)
- Oscillopsia Visual Analog Scale Score(Weeks 1, 4, 7, and 18)
- Disequilibrium Visual Analog Scale Score(Weeks 1, 4, 7, and 18)
- Gait Disorientation Test (GDT) Score(Weeks 1, 4, 7, and 18)
- Dizziness Handicap Inventory Total Score(Weeks 1, 4, 7, and 18)
- Multiple Sclerosis Quality of Life - 54 (MSQOL-54) Total Score(Weeks 1, 4, 7, and 18)
- Global Perception of Effect Score(Weeks 1, 4, 7, and 18)
- Multiple Sclerosis Quality of Life - 54 (MSQOL-54) Total Score(Weeks 1, 4, 7, and 18)
- Global Perception of Effect Score(Weeks 1, 4, 7, and 18)
- Balance Evaluation Systems Test Total Score(Weeks 1, 4, 7, and 18)
- Gait Disorientation Test (GDT) Score(Weeks 1, 4, 7, and 18)
- Dizziness Handicap Inventory Total Score(Weeks 1, 4, 7, and 18)
- Activities-specific Balance Confidence Scale Average Score(Weeks 1, 4, 7, and 18)
- Oscillopsia Visual Analog Scale Score(Weeks 1, 4, 7, and 18)
- Disequilibrium Visual Analog Scale Score(Weeks 1, 4, 7, and 18)
研究者
Colin R. Grove
Assistant Professor
Emory University