Otolith Device for Vestibular Migraine

(VIBRANT-VM Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the Otolith Labs device can alleviate symptoms for people with vestibular migraines, a type of migraine that causes dizziness. Researchers seek to assess whether using the device improves both objective (measurable) and subjective (personal) experiences of dizziness compared to not using it. Participants will test the device while sitting in a rotary chair and will answer questions about their feelings during the tests. The study seeks participants in the U.S. with definite or probable vestibular migraines.

As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance dizziness management for many.

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.

What prior data suggests that the Otolith Labs device is safe for individuals with vestibular migraine?

Research has shown that the Otolith Labs device is safe. Over 600 people have used it in studies, and none of these studies reported any serious problems caused by the device, indicating no major safety issues. The device is non-invasive, meaning it doesn't go inside the body and is generally less likely to cause harm.

Participants have tolerated the device well so far. While research continues, the safety record appears promising for those considering joining a trial with the Otolith Labs device. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Otolith Labs Device for vestibular migraine because it offers a unique, non-invasive approach to managing symptoms. Unlike standard treatments like medications that target pain or dizziness, this device uses vestibular stimulation to potentially reduce migraine symptoms directly linked to the inner ear. The device's ability to adjust stimulation levels—starting with no stimulation, then low, and finally high—provides a customizable experience tailored to individual needs. This innovative method could offer relief for those who haven't found success with traditional therapies.

What evidence suggests that the Otolith Labs device is effective for vestibular migraine?

Research shows that the Otolith Labs device, called the OtoBand, may help with balance disorders. Studies have found it can reduce the sensation of spinning, known as vertigo, in affected individuals. Trials with over 500 participants have reported no serious side effects from the device. In this trial, participants will join different arms to test the device's effectiveness. One arm will use the device with varying settings, while another will use a placebo device. Previous studies showed that the OtoBand reduced vertigo more effectively than a placebo device. These findings suggest the device could improve balance in people with vestibular migraines. ^{3 4 6 7 8}

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 had a tumor on my hearing nerve.

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

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]

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]

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]

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]

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]

Citations

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withpower.com

withpower.com/trial/phase-vestibular-migraine-7-2024-104b5

Otolith Device for Vestibular Migraine (VIBRANT-VM 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 ...

2.

scanmedicine.com

scanmedicine.com/clinicaltrials/NCT04869020

Evaluation of the OtoBand in Subjects With Self-reported ...

Primary outcomes. Change in vertigo severity rating while wearing the OtoBand compared to the change in vertigo severity while wearing a sham device.

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05157399

NCT05157399 | Quantification of the Effect of the OtoBand ...

The OtoBand has shown promise and might be beneficial for treating or improving the course of recovery from vestibular disorders. This study seeks to quantify ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04869020

Evaluation of the OtoBand in Subjects With Self-reported ...

This study seeks to gather data on the effect of a device, the OtoBand, in participants who have reported symptoms of vertigo, compared to the effect of ...

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otolithlabs.com

otolithlabs.com/clinical-study/

Clinical Studies | Otolith.com

Otolith Labs' technology has been tested in trials with over 500 participants, and there have been zero serious device-related adverse events. We are ...

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otolithlabs.com

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Otolith Labs | Solving Vertigo

Through development and clinical studies, our device has been used on over 600 subjects, with zero reportable serious device-related adverse events.

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SENSE-VM: Safety and Effectiveness of a Novel Medical ...

SENSE-VM: Safety and Effectiveness of a Novel Medical Device for Symptom Ease in Vestibular Migraines. ClinicalTrials.gov ID NCT06267924. Sponsor Otolith Labs.

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otolithlabs.com

otolithlabs.com/nvrt-technology/

nVRT Technology | Otolith.com

Otolith's device is a wearable medical device with FDA Breakthrough Designation. Utilizing our non-invasive Vestibular Resonance Therapy or nVRT technology.