Otolith Device for Vestibular Migraine

(VIBRANT-VM Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Didier Depireux, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Otolith Labs

Must not be taking: Specified medications

Disqualifiers: Head injury, Neurodegenerative disorder, others

Approved in 1 Jurisdiction

Trial Summary

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.

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Eligibility Criteria

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.

Trial Timeline

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

Participant Groups

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.

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Dizzy and Vertigo Institute of Los Angeles Beverly Hills, CA

Medical University of South Carolina Charleston, SC

Who Is Running the Clinical Trial?

Otolith Labs Lead Sponsor

Dizzy and Vertigo Institute of Los Angeles Collaborator

Medical University of South Carolina Collaborator

References

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

Treatment of Vestibular Migraine: A Systematic Review and Meta-analysis. [2021] To assess the efficacy of the various therapies used for the prevention of vestibular migraine (VM).

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

Preventing Episodic Migraine With Caloric Vestibular Stimulation: A Randomized Controlled Trial. [2019] To evaluate the safety and efficacy of a novel solid-state, caloric vestibular stimulation (CVS) device to provide adjuvant therapy for the prevention of episodic migraine in adult migraineurs.

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

The clinical utility of vestibular autorotation test in patients with vestibular migraine. [2018] To investigate the characteristics and clinical utility of vestibular autorotation test (VAT) in patients with vestibular migraine.

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

Migraine management for the otolaryngologist. [2023] To characterize migraine pathophysiology, presentation, and current treatment strategies, specifically in regard to vestibulocochlear manifestations of migraine.

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

[Progress in research of vestibular migraine]. [2019] Estibular migraineis a common disease with symptoms of vertigo and migraine，which is the most common type of recurrent vertigo. The overall prevalence rate of the population is up to 1%. However, owing to its diversity of symptoms, large individual differences, the scarcity of professional clinical knowledge and the lack of effective diagnostic means, the rate of misdiagnosis is very high. Therefore, this article summarized the parts of clinical manifestations, pathogenesis, diagnostic criteria, treatment and prevention of vestibular migraine.