Multiple Sclerosis
Conditions
Keywords
Treatment of multiple sclerosis, Incremental Vestibulo-ocular Reflex Adaptation, Dizziness in people with multiple sclerosis
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.
Interventions
DEVICEStableEyes
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 head unit.
Sponsors
National Multiple Sclerosis Society
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite VOR gain (cVOR gain) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Best Corrected Dynamic Visual Acuity (During Head Movements) | Weeks 0,1, 4, 7, and 18 | 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. |
| Balance Evaluation Systems Test Total Score | Weeks 1, 4, 7, and 18 | 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 |
| Gait Disorientation Test (GDT) Score | Weeks 1, 4, 7, and 18 | 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. |
| Dizziness Handicap Inventory Total Score | Weeks 1, 4, 7, and 18 | 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. |
| Global Perception of Effect Score | Weeks 1, 4, 7, and 18 | 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. |
| Oscillopsia Visual Analog Scale Score | Weeks 1, 4, 7, and 18 | 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 |
| Disequilibrium Visual Analog Scale Score | Weeks 1, 4, 7, and 18 | 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. |
| Multiple Sclerosis Quality of Life - 54 (MSQOL-54) Total Score | Weeks 1, 4, 7, and 18 | 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. |
| Activities-specific Balance Confidence Scale Average Score | Weeks 1, 4, 7, and 18 | 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. |
Countries
United States
Contacts
Primary ContactColin Grove, PT, DPT, MS, PhD
Backup ContactColin Grove
Outcome results
None listed