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Behavioural Intervention

Otolith Device for Vestibular Migraine (VIBRANT-VM Trial)

N/A
Recruiting
Led By Didier Depireux, PhD
Research Sponsored by Otolith Labs
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Definite or probable vestibular migraine
Be older than 18 years old
Must not have
Neurodegenerative disorder
History of radiographically unexplored unilateral or sudden sensorineural hearing loss
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 minutes

Summary

"This trial aims to see if the Otolith Labs device can help improve balance in people with vestibular migraine. They will test if the device makes objective and subjective measures of balance better when it is

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects are not explicitly listed but may include discomfort or increased susceptibility to motion sickness due to the use of the rotary chair during testing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with vestibular migraine.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a condition that causes my brain or nerves to deteriorate over time.
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I have experienced sudden hearing loss that hasn't been examined with imaging.
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I have had surgery on the base of my skull or head.
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I have had surgery on my inner ear.
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I have a history of ear disease or have taken medication that could harm my hearing.
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I have had vestibular neuritis or labyrinthitis.
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I have had a tumor on my hearing nerve.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Reduction of time constant
Secondary study objectives
Motion sickness experience
Motion sickness symptom
Vestibular migraine handicap

Trial Design

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.

Find a Location

Who is running the clinical trial?

Otolith LabsLead Sponsor
10 Previous Clinical Trials
538 Total Patients Enrolled
Dizzy and Vertigo Institute of Los AngelesUNKNOWN
1 Previous Clinical Trials
28 Total Patients Enrolled
Medical University of South CarolinaOTHER
973 Previous Clinical Trials
7,399,342 Total Patients Enrolled
~28 spots leftby Jun 2025
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