Incremental Vestibulo-ocular Reflex Adaptation as a Novel Treatment for Dizziness in People With Multiple Sclerosis
NCT Number: NCT06495138
Acronym: DIIVA-MS
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Multiple Sclerosis
Interventions: DEVICE: StableEyes
Sponsor: Emory University
Collaborators: National Multiple Sclerosis Society
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 138
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2027-03
Locations: Emory Univeristy, Atlanta, Georgia, 30329, United States

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.

Primary Outcome Measures: Composite VOR gain (cVOR gain), 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., Weeks 1,4, 7, and 18
Secondary Outcome Measures: Best Corrected Dynamic Visual Acuity (During Head Movements), The ability of participants to see clearly while their head is in motion (e.g., during self-generated head movements while seated, while walking at their preferred walking speed) will be assessed using commercially available hardware and custom software while the participant's head is moving., Weeks 1, 4, 7, and 18|Balance Evaluation Systems Test Total Score, The BEST will be instrumented using inertial measurement units (IMU) placed at the head, upper torso, pelvis, and both ankles. The BEST is a 36-item assessment of the body systems that contribute to balance and walking. Total scores range from 0 to 108 points, Weeks 1, 4, 7, and 18|Gait Disorientation Test (GDT) Score, The GDT is a 2-item assessment of aspects of spatial navigation. Task 1 is to walk 20 feet with eyes open. Task 2 is to walk 20 feet with eyes closed. Both tasks are timed, and the GDT result is the time needed to walk with eyes closed minus the time needed to walk with eyes open., Weeks 1, 4, 7, and 18|Dizziness Handicap Inventory Total Score, The DHI be used to assess participants' perceived level of handicap due dizziness. This measure consists of 25 questions that are answered as "yes" = 4 points (dizziness is always a factor), "sometimes" = 2 points (dizziness is sometimes a factor), or "no" = 0 points (dizziness is never a factor) for a given situation or issue. The maximum total score on this measure is 100 points with higher scores indicating higher levels of perceived handicap., Weeks 1, 4, 7, and 18|Activities-specific Balance Confidence Scale Average Score, The ABCS consists of 16 questions for which the respondent answers how confident they feel in not becoming unsteady or falling in specific situations. Confidence is rated on a scale of 0% to 100% with 0% indicating "no confidence" and 100% indicating "complete confidence' in the ability to maintain balance. Average scores of ≥ 80% are associated with high levels of physical functioning in adults., Weeks 1, 4, 7, and 18|Oscillopsia Visual Analog Scale Score, Visual analog scales are commonly used in clinical practice and research. The investigator will measure the severity of oscillopsia (unstable vision during head movement) and sense of disequilibrium while the participant walks 20' on separate visual analog scales. The distance from the zero anchor to the respondent's marking will be measured without units but to the nearest tenth. The response for each scale will be transformed to a 100-point scale, Weeks 1, 4, 7, and 18|Disequilibrium Visual Analog Scale Score, The investigator will measure the sense of disequilibrium while the participant walks 20' on separate visual analog scales. The distance from the zero anchor to the respondent's marking will be measured without units but to the nearest tenth.

The response for the scale will be transformed to a 100-point scale., Weeks 1, 4, 7, and 18|Multiple Sclerosis Quality of Life - 54 (MSQOL-54) Total Score, The MSQOL-54 is a multidimensional measure that consists of questions related to general and MS-specific health-related quality of life. The MSQOL-54 was created by adding 18 items related to MS-specific issues, e.g., fatigue and cognitive function., Weeks 1, 4, 7, and 18|Global Perception of Effect Score, The investigator will assess perception of change retrospectively across the entire study period with ratings using an 11-point Likert scale with anchors of "very much better" and "very much worse" with a middle point labeled "no change" to assess the magnitude of change in symptoms., Weeks 1, 4, 7, and 18