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

Trial Summary

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 data supports the effectiveness of the treatment StableEyes for dizziness in multiple sclerosis?

Research suggests that vestibular rehabilitation, which involves exercises to improve balance and eye movement control, can help people with multiple sclerosis who experience dizziness. Studies have shown improvements in balance and reduced dizziness symptoms in patients undergoing similar rehabilitation therapies. ^{1 2 3 4 5}

Is StableEyes safe for humans?

The available research does not provide specific safety data for StableEyes, but it discusses the importance of monitoring adverse events (unwanted side effects) in treatments for multiple sclerosis. This includes using registries to track side effects and ensuring adherence to treatment to minimize adverse events. ^{6 7 8 9 10}

How is the treatment StableEyes different from other treatments for dizziness in multiple sclerosis?

StableEyes is unique because it focuses on improving gaze and postural stability through vestibular rehabilitation, which is a therapy that helps the brain adjust to balance and eye movement issues. This approach is different from standard drug treatments, as it uses physical therapy techniques to address the underlying vestibular dysfunction in multiple sclerosis. ^{1 4 5 11 12}

What is the purpose of this trial?

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.

Research Team

Colin Grove, PT, MS, DPT, PhD

Principal Investigator

Emory University

Eligibility Criteria

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

I have had a single neurological event or MRI findings suggestive of MS.

My MS symptoms have gotten worse in the last 60 days.

Timeline

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

Treatment Details

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.

Participant Groups

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.

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+

Findings from Research

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Rehabilitation to improve gaze and postural stability in people with multiple sclerosis: study protocol for a prospective randomized clinical trial. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Effects of balance exercises on people with multiple sclerosis: a pilot study. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

[Vestibular rehabilitation in patients with relapsing-remitting multiple sclerosis]. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Comprehensive Clinical Assessment of Vestibular Function in Multiple Sclerosis. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Greater Disability Is Associated with Worse Vestibular and Compensatory Oculomotor Functions in People Living with Multiple Sclerosis. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Ocular adverse events from pharmacological treatment in patients with multiple sclerosis-A systematic review of the literature. [2022]

7. New Zealand 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. [2022]

8. England pubmed.ncbi.nlm.nih.gov

A review of disease-modifying therapies for MS: maximizing adherence and minimizing adverse events. [2019]

9. Germany pubmed.ncbi.nlm.nih.gov

Natalizumab adverse events are rare in patients with multiple sclerosis. [2019]

10. United States 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. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Test-Retest Reliability and Response Stability of Gaze Stabilization, Postural Sway, and Dynamic Balance Tests in Persons with Multiple Sclerosis and Controls. [2022]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Direction-specific impairments of limits of stability in individuals with multiple sclerosis. [2016]