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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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

Первичные конечные точки

• Composite VOR gain (cVOR gain) [Срок оценки: Weeks 0,1,2,3,4,5,6, 7, and 18]

Вторичные конечные точки (9)

• Best Corrected Dynamic Visual Acuity (During Head Movements) [Срок оценки: Weeks 0,1, 4, 7, and 18]
• Balance Evaluation Systems Test Total Score [Срок оценки: Weeks 1, 4, 7, and 18]
• Gait Disorientation Test (GDT) Score [Срок оценки: Weeks 1, 4, 7, and 18]
• Dizziness Handicap Inventory Total Score [Срок оценки: Weeks 1, 4, 7, and 18]
• Activities-specific Balance Confidence Scale Average Score [Срок оценки: Weeks 1, 4, 7, and 18]
• Oscillopsia Visual Analog Scale Score [Срок оценки: Weeks 1, 4, 7, and 18]
• Disequilibrium Visual Analog Scale Score [Срок оценки: Weeks 1, 4, 7, and 18]
• Multiple Sclerosis Quality of Life - 54 (MSQOL-54) Total Score [Срок оценки: Weeks 1, 4, 7, and 18]
• Global Perception of Effect Score [Срок оценки: Weeks 1, 4, 7, and 18]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Emory Univeristy — Atlanta

Идентификаторы

NCT: NCT06495138 · STUDY00007558 · RG-2307-41945

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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