Otolith Device for Vestibular Migraine

(VIBRANT-VM Trial)

Recruiting at 1 trial location

Overseen By Kevin Grant, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Otolith Labs

Must not be taking: Specified medications

Disqualifiers: Head injury, Neurodegenerative disorder, others

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

42 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to learn if the Otolith Labs device can improve vestibular function of subjects with vestibular migraine. The main questions it aims to answer are: * When the Otolith Labs device is on, are objective measures of the vestibular system better than when the device is off? * When the Otolith Labs device is on are subjective measures of the vestibular system better than when the device is off? * Are the objective measures related to the subjective measures? Researchers will change the order of the device settings to ensure the changes aren't due to the order they are tested. Participants will: * Wear the Otolith Labs device while in a rotary chair at different settings for different tests. All of the rotary chair testing will take less than an hour. * Answer questions about how the rotary chair testing made them feel for each test. * Answer questions about their every-day susceptibility to motion sickness and about their vestibular migraine symptoms.

Do I have to stop taking my current medications for the trial?

The trial mentions 'recent use of specified medications' as an exclusion criterion, but it doesn't specify which medications. It's unclear if you need to stop taking your current medications, so you should check with the trial organizers for more details.

How is the Otolith Labs Device treatment different from other treatments for vestibular migraine?

The Otolith Labs Device is unique because it uses nVRT Technology, which likely involves non-invasive vestibular stimulation to manage symptoms, unlike traditional medications that target migraine pain or vertigo separately. This device offers a novel approach by potentially addressing the vestibular (balance-related) component directly. ^{1 2 3 4 5}

Who Is on the Research Team?

Didier Depireux, PhD

Principal Investigator

Otolith Labs

Are You a Good Fit for This Trial?

This trial is for individuals with vestibular migraines, a type of migraine that can cause dizziness and balance problems. Participants should be able to sit in a rotary chair and answer questions about their symptoms and susceptibility to motion sickness.

Inclusion Criteria

I have been diagnosed with vestibular migraine.

Residing in the United States

Exclusion Criteria

I have not had a head injury in the past 6 months.

I have a condition that causes my brain or nerves to deteriorate over time.

I have experienced sudden hearing loss that hasn't been examined with imaging.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Testing

Participants undergo rotary chair testing with the Otolith Labs device at different power settings to evaluate vestibular function

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after testing

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Otolith Labs Device

Trial Overview The study tests an Otolith Labs device's effect on vestibular function. It compares results when the device is active versus inactive during rotary chair tests, assessing both objective measures of the vestibular system and subjective experiences.

How Is the Trial Designed?

Group I: Off low high Experimental Treatment 1 Intervention

Device order will start with the device turned on but stimulation off, then the low setting and then the high setting

Group II: Off high low Experimental Treatment 1 Intervention

Device order will start with the device turned on but stimulation off, then the high setting and then the low setting

Group III: Off off off Placebo Group 1 Intervention

Device will always be turned on but stimulation off to measure test-retest variability.

Otolith Labs Device is already approved in United States for the following indications:

Approved in United States as Otolith Labs Device for:

• Vestibular Migraine
• Chronic Vertigo
• Meniere's Disease
• BPPV

Who Is Running the Clinical Trial?

Otolith Labs

Lead Sponsor

Trials

11

Recruited

700+

Dizzy and Vertigo Institute of Los Angeles

Collaborator

Trials

2

Recruited

70+

Medical University of South Carolina

Collaborator

Trials

994

Recruited

7,408,000+

Published Research Related to This Trial

A systematic review of 13 studies involving patients with vestibular migraine (mean age 43.3 years, predominantly female) found that various treatment options, including antiepileptic drugs and β-blockers, showed improvements in dizziness and vertigo frequency.

Despite the positive outcomes from different therapies, significant variability in study results and lack of standardized measures prevented the identification of a preferred treatment, highlighting the need for more rigorous future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of Vestibular Migraine: A Systematic Review and Meta-analysis. Byun, YJ., Levy, DA., Nguyen, SA., et al.[2021]

The TNM™ device for caloric vestibular stimulation (CVS) significantly reduced the number of migraine days in adult participants, with an average decrease of 3.9 days compared to a 1.1-day reduction in the placebo group, indicating its efficacy as an adjuvant therapy for episodic migraine prevention.

The device was well-tolerated, with no adverse effects on mood, cognition, or balance reported, and a high treatment adherence rate of 90%, suggesting it is a safe option for migraineurs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventing Episodic Migraine With Caloric Vestibular Stimulation: A Randomized Controlled Trial. Wilkinson, D., Ade, KK., Rogers, LL., et al.[2019]

The vestibular autorotation test (VAT) showed significant differences in results between 441 patients with vestibular migraine and 65 healthy controls, indicating its potential as a diagnostic tool for vestibular migraine (VM).

Patients with VM exhibited elevated horizontal and vertical gains, as well as delays in phase at various frequencies, suggesting that VAT can provide objective evidence to aid in diagnosing VM and differentiating it from other conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The clinical utility of vestibular autorotation test in patients with vestibular migraine. Thungavelu, Y., Wang, W., Lin, P., et al.[2018]

Migraine can present with vestibulocochlear symptoms like vertigo and hearing loss, which may not include the typical headache, making it harder to recognize as migraine-related; this is linked to trigeminal innervation and CGRP expression in the inner ear.

Current treatment strategies focus on abortive therapies (like triptans and anti-emetics) and prophylactic medications (such as beta-blockers and CGRP monoclonal antibodies), which can also help alleviate vestibular symptoms associated with migraine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Migraine management for the otolaryngologist. Brooks, KA., Tawk, K., Djalilian, HR., et al.[2023]

Vestibular migraine, affecting about 1% of the population, is characterized by symptoms of vertigo and migraine, but is often misdiagnosed due to its diverse symptoms and lack of clinical knowledge.

The article provides a comprehensive overview of vestibular migraine, including its clinical manifestations, underlying causes, diagnostic criteria, and treatment options, highlighting the need for better awareness and understanding in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Progress in research of vestibular migraine]. Gong, LN., Yu, DZ., Yin, SK.[2019]

Citations

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

Treatment of Vestibular Migraine: A Systematic Review and Meta-analysis. [2021]

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

Preventing Episodic Migraine With Caloric Vestibular Stimulation: A Randomized Controlled Trial. [2019]

3. England pubmed.ncbi.nlm.nih.gov

The clinical utility of vestibular autorotation test in patients with vestibular migraine. [2018]

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

Migraine management for the otolaryngologist. [2023]

5. China pubmed.ncbi.nlm.nih.gov

[Progress in research of vestibular migraine]. [2019]