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Device

Otoband for Vestibular Migraines

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

Male or female subjects, age 18 to 75 years old inclusive on day of enrollment

Diagnosed as having Vestibular Migraine (VM) by a physician Board certified in Otolaryngology or Neurology

Must not have

Females who are pregnant or trying to become pregnant

Taking benzodiazepines (e.g., clonazepam, lorazepam, diazepam)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 23 - day 51

Summary

This trial aims to compare two devices for treating chronic Vestibular Migraines in adults. Participants will be enrolled for up to 50 days and will use one of the study devices as instructed.

Who is the study for?

Adults aged 18-75 with chronic Vestibular Migraines, also known as Migraine Associated Vertigo, can join this trial. They must have a physician's diagnosis of vertigo and be able to participate in virtual visits and keep daily diaries for up to 50 days.

What is being tested?

The SENSE-VM trial is testing two devices: the Otoband Experimental and the Otoband Sham. Participants will use one device over a period of time to see if it helps ease their migraine symptoms better than the other.

What are the potential side effects?

Since this trial involves non-invasive medical devices rather than drugs, side effects may include discomfort or skin irritation where the device is worn. Other potential side effects are not specified but should be minimal.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 75 years old.

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I have been diagnosed with Vestibular Migraine by a specialist.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently pregnant or trying to conceive.

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I am currently taking benzodiazepines.

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I have not had skull base surgery in the last 6 months and have no plans for such surgery while enrolled.

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I have been diagnosed with hyperacusis.

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I am currently in or will start vestibular rehabilitation therapy during the study.

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I have had a stroke or other brain blood flow problems.

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I have a tumor in the back part of my brain or a vestibular schwannoma.

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My condition involves progressive brain damage.

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I am able to understand and follow the study's procedures.

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I have a small hole in the inner ear bone.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 23 - day 51

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 23 - day 51

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 23 - day 51 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

DHI Change in Scores

Secondary study objectives

Change in number of vestibular migraine episodes weekly

DHI change from transition to end of study

Device responder rate

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: 1. Moderate or Worse (MoW) ArmExperimental Treatment1 Intervention

Participants will be randomized to use the Otoband as instructed by clinical coordinator per study protocol. There are 4 power levels, these participants will receive the experimental device.

Group II: 2. Moderate or Worse (MoW) ArmPlacebo Group1 Intervention

Participants will be randomized to use the Otoband as instructed by clinical coordinator per study protocol. There are 4 power levels, these participants will receive the sham device.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Otoband Experimental

2023

N/A

~110

0 / 12Eligibility criteria met