NCT06495138 · Emory University
Incremental Vestibulo-ocular Reflex Adaptation as a Novel Treatment for Dizziness in People With Multiple Sclerosis
(DIIVA-MS)
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
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 head unit.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Atlanta, Georgia
Collaborators
National Multiple Sclerosis Society
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 16, 2025 · Source of record for eligibility and locations