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| ID | Type | Description | Link |
|---|---|---|---|
| RG-2307-41945 | Other Identifier | National Multiple Sclerosis Society |
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| Name | Class |
|---|---|
| National Multiple Sclerosis Society | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daily Incremental Vestibulo-ocular Reflex Adaptation (D-IVA-GSE) | Experimental | The dosages of the D-IVA-GSE and I-IVA-GSE are based on the FITT principle of exercise prescription (frequency, intensity, time, and type). The D-IVA-GSE group will perform two, 15- minute GSE sessions (30-minutes total per day), seven days per week. |
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| Intermittent incremental vestibulo-ocular Reflex Adaptation (I-IVA-GSE) | Experimental | The I-IVA-GSE group will perform two, 15-minute IVA-GSE sessions (30 minutes total), three days per week, with at least one day between each exercise day. |
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| Helathy Control | No Intervention | The healthy control group will complete the same baseline assessments as the subjects in the Multiple Sclerosis (MS) group to serve as normative reference data. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| StableEyes | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 0,1,2,3,4,5,6, 7, and 18 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 0,1, 4, 7, and 18 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Colin Grove, PT, DPT, MS, PhD | Contact | (404) 712-8685 | colin.r.grove@emory.edu | |
| Colin Grove | Contact | (404) 712-8685 | colin.r.grove@emory.edu |
| Name | Affiliation | Role |
|---|---|---|
| Colin Grove, PT, MS, DPT, PhD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory Univeristy | Recruiting | Atlanta | Georgia | 30329 | United States |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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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.
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| 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 |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |