StableEyes for Dizziness in Multiple Sclerosis

(DIIVA-MS Trial)

Overseen By Colin Grove

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Cognitive impairment, High blood pressure, Visual acuity, Ocular misalignment, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 18 weeks

138 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people with multiple sclerosis (MS) who experience dizziness and balance problems. Researchers seek to determine if daily exercises to improve eye movement control are more effective than performing them a few times a week. The treatment, called StableEyes, targets these vestibular (balance-related) symptoms. Individuals with MS who often feel dizzy and have experienced at least two falls in the past year might be suitable candidates for this trial.

As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance daily life for those with MS.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have changed your immunotherapy in the last 60 days, you may not be eligible to participate.

What prior data suggests that this gaze stabilization training is safe for people with multiple sclerosis?

Research has shown that two new methods, Daily Incremental Vestibulo-ocular Reflex Adaptation (D-IVA-GSE) and Intermittent Incremental Vestibulo-ocular Reflex Adaptation (I-IVA-GSE), may reduce dizziness in people with multiple sclerosis (MS). These methods aim to improve the vestibulo-ocular reflex (VOR), which stabilizes vision during quick head movements.

Treatments targeting the VOR are generally considered safe and well-tolerated. This study is in a phase called "Not Applicable," indicating no previous data on the safety of these specific methods. However, similar exercises to improve VOR typically do not cause serious side effects and are well-tolerated by patients.

Consider personal comfort and any specific concerns. Discussing with a healthcare provider can help determine if joining this trial is suitable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the StableEyes treatments because they focus on vestibulo-ocular reflex adaptation exercises, which are a fresh approach to managing dizziness in people with multiple sclerosis (MS). Unlike standard treatments for MS-related dizziness, which often involve medication or physical therapy, the Daily Incremental (D-IVA-GSE) and Intermittent Incremental (I-IVA-GSE) protocols use structured eye and head movement exercises to enhance balance and stability. These exercises are based on the FITT principle, offering a tailored approach by adjusting frequency, intensity, time, and type, which could lead to more effective symptom management. This innovative method has the potential to improve quality of life without relying on drugs, making it a promising non-pharmacological option.

What evidence suggests that StableEyes might be an effective treatment for dizziness in multiple sclerosis?

Research has shown that gaze stabilization exercises (GSE) effectively reduce symptoms like dizziness and visual disturbances in various conditions. These exercises are commonly used to manage such symptoms. In this trial, participants will be assigned to different arms to test the effectiveness of daily versus intermittent versions of these exercises. Studies have found that gradually increasing head movement helps lessen motion sickness and improve stability. This finding is encouraging for people with multiple sclerosis who have balance issues. Early results suggest that these exercises can improve balance and reduce dizziness by training the eyes and head to move more smoothly together. ^{6 7 8 9 10}

Who Is on the Research Team?

Colin Grove, PT, MS, DPT, PhD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for people with primary progressive or relapsing and remitting multiple sclerosis who experience dizziness, imbalance, or have had falls. Participants must speak English fluently and not have had recent MS symptom worsening, immunotherapy changes, severe high blood pressure, certain eye conditions like lazy eye or ongoing vestibular rehabilitation.

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

Fluent in speaking and understanding English

I often feel dizzy, have balance issues, and have fallen at least twice in the last year.

Exclusion Criteria

Static visual acuity with correction of worse than 1.0 logMAR

Systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 90 mmHg at rest

Convergence insufficiency

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo daily or intermittent gaze stabilization exercises using StableEyes technology to improve vestibulo-ocular reflex adaptation

18 weeks

Weekly assessments at weeks 1, 4, 7, and 18

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• StableEyes

Trial Overview The study tests a new treatment called StableEyes aimed at reducing dizziness in those with multiple sclerosis. It compares daily personalized gaze stabilization training against intermittent training to see which helps more with vestibular symptoms.

How Is the Trial Designed?

Group I: Intermittent incremental vestibulo-ocular Reflex Adaptation (I-IVA-GSE) Experimental Treatment 1 Intervention

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.

Group II: Daily Incremental Vestibulo-ocular Reflex Adaptation (D-IVA-GSE) Experimental Treatment 1 Intervention

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.

Group III: Helathy Control Active Control 1 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 Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Multiple Sclerosis Society

Collaborator

Trials

100

Recruited

10,600+

Published Research Related to This Trial

In a study of 275 patients with relapsing remitting multiple sclerosis treated with intramuscular interferon beta-1a (INFb-1a) over 24 months, 75.3% experienced treatment-related adverse events (AEs), with most being mild (68.5%).

The incidence of common AEs such as headache and fatigue was significantly lower in this real-world study compared to the pivotal phase III trial, suggesting that INFb-1a has a favorable safety profile in daily practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events of interferon beta-1a: a prospective multi-centre international ICH-GCP-based CRO-supported external validation study in daily practice. Jongen, PJ., Sindic, C., Sanders, E., et al.[2021]

The REGIMS registry is a multicenter observational study in Germany that collects data on the side effects of immunotherapies for multiple sclerosis, providing valuable insights into the long-term safety of these treatments.

By the end of 2019, REGIMS had recruited 1000 patients, primarily women with relapse-remitting MS, demonstrating the registry's ability to gather high-quality, real-world data despite facing logistical challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chances and Challenges of Registry-Based Pharmacovigilance in Multiple Sclerosis: Lessons Learnt from the Implementation of the Multicenter REGIMS Registry. Simbrich, A., Thibaut, J., Khil, L., et al.[2022]

A systematic review identified 67 articles detailing ocular treatment-emergent adverse events (TEAEs) related to multiple sclerosis therapies, highlighting that drugs like fingolimod and siponimod are commonly associated with macular edema, while interferon β is linked to retinopathy.

The study emphasizes the need for longitudinal research on ocular TEAEs in multiple sclerosis treatments, particularly in underrepresented regions, and suggests that physicians should closely monitor patients for ocular symptoms during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ocular adverse events from pharmacological treatment in patients with multiple sclerosis-A systematic review of the literature. Muñoz-Ortiz, J., Reyes-Guanes, J., Zapata-Bravo, E., et al.[2022]

Citations

1. researchgate.net researchgate.net/publication/358396210_Reporting_of_exercise_dose_and_dosage_and_outcome_measures_for_gaze_stabilisation_in_the_literature_a_scoping_review

Reporting of exercise dose and dosage and outcome ... Gaze stabilization exercises (GSE) are considered the standard of care for mitigating the troubling symptoms (i.e., oscillopsia, dizziness) and ...

2. ouci.dntb.gov.ua ouci.dntb.gov.ua/en/works/lmpqJEm4/

Reporting of exercise dose and dosage and outcome measures ... Reporting of exercise dose and dosage and outcome measures for gaze stabilisation in the literature: a scoping review · General information · Details · Abstract.

3. withpower.com withpower.com/trial/phase-4-sclerosis-10-2021-6d5f7

Ofatumumab for Multiple Sclerosis (SOSTOS Trial) Ofatumumab has been shown to be more effective than teriflunomide in reducing relapse rates and MRI-detected lesions in people with relapsing multiple sclerosis ...

4. ouci.dntb.gov.ua ouci.dntb.gov.ua/en/works/4wgn1DZ4/

Comparison of Incremental Vestibulo-ocular Reflex Adaptation ... Material and Methods. This is a prospective and longitudinal study of 67 patients diagnosed with VN. Inclusion criteria were sudden onset of vertigo, ...

5. trialstoday.org trialstoday.org/search/results?status=recruiting&gender=&age=&zip=&radius=25&condition=&healthy=&type=&interventionalpurpose=&observationalmodel=&query=University%20of%20Iowa%20Neurology&page=eJyLVspLrShR0lHycw4xMDUxMDA1NFLS0bWEARxMCz1DCzMLCzMdQ3OQJjMgBgIdpbzkEgMzYxNzEwsTpVgA1LwUlw--

Save Selected The investigators have developed a self-administered rehabilitation tool that incrementally guides the user to increase head motion to mitigate motion sickness ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06495138

Incremental Vestibulo-ocular Reflex Adaptation as a Novel ... 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.

7. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/587719

Incremental Vestibulo-ocular Reflex Adaptation as a Novel ... The study aims to study the effects of a novel treatment for vestibular symptoms in people with multiple sclerosis.

8. trialx.com trialx.com/clinical-trials/listings/300318/incremental-vestibulo-ocular-reflex-adaptation-as-a-novel-treatment-for-dizziness-in-people-with-multiple-sclerosis/

Incremental Vestibulo-ocular Reflex Adaptation as a Novel ... Overview. The study aims to study the effects of a novel treatment for vestibular symptoms in people with multiple sclerosis.

9. clinicaltrial.be clinicaltrial.be/en/details/442106?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

Incremental Vestibulo-ocular Reflex Adaptation as a Novel... Improved VOR function can reduce dizziness and improve the quality of life for people with MS. Trial design. Interventions. 1. StableEyes.

10. researchgate.net researchgate.net/publication/325075758_StableEyes_-_A_Portable_Vestibular_Rehabilitation_Device

StableEyes - A Portable Vestibular Rehabilitation Device The vestibulo-ocular reflex (VOR) is the primary mechanism for stabilising vision during rapid head movements. We have developed a training technique that ...