Multiple SclerosisDIIVA-MSNCT06495138
Incremental Vestibulo-ocular Reflex Adaptation as a Novel Treatment for Dizziness in People With Multiple Sclerosis
A study testing StableEyes in people with Multiple Sclerosis, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- StableEyes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2025to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Emory Univeristy
Atlanta, Georgia, 30329
About this study
Official title: Daily Versus Intermittent Incremental Vestibulo-ocular Reflex Adaptation as a Novel Treatment for Dizziness in People With Multiple Sclerosis
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- StableEyes
- Keywords
- Treatment of multiple sclerosis, Incremental Vestibulo-ocular Reflex Adaptation, Dizziness in people with multiple sclerosis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StableEyesDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: StableEyes |
| 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. Receives: Device: StableEyes |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Weeks 0,1,2,3,4,5,6, 7, and 18
Secondary outcomes (9)
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.
Measured: Weeks 0,1, 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Weeks 1, 4, 7, and 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start21 Apr 2025
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Multiple Sclerosis Society
- Responsible party
- Principal investigator, Colin R. Grove, Emory University
- Investigators
- Colin Grove, PT, MS, DPT, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06495138
- Sponsor's protocol ID
- STUDY00007558
- Other IDs
- RG-2307-41945
- Acronym
- DIIVA-MS
- Status last verified
- Oct 2026
- First submitted
- 2 Jul 2024
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daily Versus Intermittent Incremental Vestibulo-ocular Reflex Adaptation as a Novel Treatment for Dizziness in People With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06495138
- Acronym / sponsor ID
- DIIVA-MS / STUDY00007558
- Conditions
- Multiple Sclerosis
- Keywords
- Treatment of multiple sclerosis, Incremental Vestibulo-ocular Reflex Adaptation, Dizziness in people with multiple sclerosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Multiple Sclerosis Society
- Study start
- 21 Apr 2025 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 10 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Daily Incremental Vestibulo-ocular Reflex Adaptation (D-IVA-GSE) | Experimental | Device: StableEyesThe 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. |
| Intermittent incremental vestibulo-ocular Reflex Adaptation (I-IVA-GSE) | Experimental | Device: StableEyesThe 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. |
| 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. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StableEyesGaze 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. | Device | Daily Incremental Vestibulo-ocular Reflex Adaptation (D-IVA-GSE), Intermittent incremental vestibulo-ocular Reflex Adaptation (I-IVA-GSE) |
Primary outcome
Composite VOR gain (cVOR gain)
Time frame: 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.
9 secondary outcomes
Best Corrected Dynamic Visual Acuity (During Head Movements)
Time frame: Weeks 0,1, 4, 7, and 18
Balance Evaluation Systems Test Total Score
Time frame: Weeks 1, 4, 7, and 18
Gait Disorientation Test (GDT) Score
Time frame: Weeks 1, 4, 7, and 18
Dizziness Handicap Inventory Total Score
Time frame: Weeks 1, 4, 7, and 18
Activities-specific Balance Confidence Scale Average Score
Time frame: Weeks 1, 4, 7, and 18
Oscillopsia Visual Analog Scale Score
Time frame: Weeks 1, 4, 7, and 18
Disequilibrium Visual Analog Scale Score
Time frame: Weeks 1, 4, 7, and 18
Multiple Sclerosis Quality of Life - 54 (MSQOL-54) Total Score
Time frame: Weeks 1, 4, 7, and 18
Global Perception of Effect Score
Time frame: Weeks 1, 4, 7, and 18
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Colin Grove, PT, MS, DPT, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing StableEyes in people with Multiple Sclerosis, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Colin Grove, PT, DPT, MS, PhD ((404) 712-8685, colin.r.grove@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite VOR gain (cVOR gain) (time frame: Weeks 0,1,2,3,4,5,6, 7, and 18). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.