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Behavioural Intervention

StableEyes for Dizziness in Multiple Sclerosis (DIIVA-MS Trial)

N/A

Waitlist Available

Led By Colin Grove, PT, MS, DPT, PhD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have self-reported vestibular symptoms of dizziness, imbalance, and/or a history of at least two falls in the prior 12 months

Be older than 18 years old

Must not have

Clinically isolated syndrome or radiologically isolated syndrome

Self-reported cognitive impairment that limits independence with basic and instrumental activities of daily living

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 1,4, 7, and 18

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test a new treatment for balance issues in people with multiple sclerosis. The goal is to see if daily personalized training for stabilizing vision is better than training done intermittently.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While the specific side effects of StableEyes are not detailed here, similar treatments may cause temporary discomfort or strain in the eyes and neck due to exercises involved in gaze stabilization training.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I struggle with memory or thinking skills that affect my daily independence.

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I have a noticeable eye misalignment of 5 diopters or more.

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I have a condition affecting eye movement.

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I have been diagnosed with benign paroxysmal positional vertigo.

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I have a major spine or walking issue due to an orthopedic condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 1,4, 7, and 18

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 1,4, 7, and 18

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 1,4, 7, and 18 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Composite VOR gain (cVOR gain)

Secondary study objectives

Activities-specific Balance Confidence Scale Average Score

Balance Evaluation Systems Test Total Score

Best Corrected Dynamic Visual Acuity (During Head Movements)

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Intermittent incremental vestibulo-ocular Reflex Adaptation (I-IVA-GSE)Experimental Treatment1 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 Treatment1 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.

0 / 7Eligibility criteria met