42 Participants Needed

Otolith Device for Vestibular Migraine

(VIBRANT-VM Trial)

Recruiting at 1 trial location
KF
KG
Overseen ByKevin Grant, MS
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

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.12345

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.

Research Team

DD

Didier Depireux, PhD

Principal Investigator

Otolith Labs

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.
See 8 more

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

Treatment Details

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.
Participant Groups
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Off low highExperimental Treatment1 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 lowExperimental Treatment1 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 offPlacebo Group1 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

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+

Findings from Research

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

References

Treatment of Vestibular Migraine: A Systematic Review and Meta-analysis. [2021]
Preventing Episodic Migraine With Caloric Vestibular Stimulation: A Randomized Controlled Trial. [2019]
The clinical utility of vestibular autorotation test in patients with vestibular migraine. [2018]
Migraine management for the otolaryngologist. [2023]
[Progress in research of vestibular migraine]. [2019]
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