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Device

1. Moderate or Worse (MoW) Arm for Vestibular Migraine

N/A

Waitlist Available

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 23 - day 51

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

DHI Change in Scores

Secondary outcome measures

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Otolith LabsLead Sponsor

9 Previous Clinical Trials

338 Total Patients Enrolled

2 Trials studying Vestibular Migraine

137 Patients Enrolled for Vestibular Migraine

MCRAIndustry Sponsor

31 Previous Clinical Trials

9,056 Total Patients Enrolled

1 Trials studying Vestibular Migraine

109 Patients Enrolled for Vestibular Migraine

Didier Depireux, PhDPrincipal InvestigatorOtolith Labs

5 Previous Clinical Trials

230 Total Patients Enrolled

1 Trials studying Vestibular Migraine

109 Patients Enrolled for Vestibular Migraine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for me to participate in this ongoing medical study?

"In order to be eligible for enrollment, individuals must have a diagnosis of vestibular migraine and fall within the age range of 18 to 75. A total of 200 participants are sought for this study."

Answered by AI

Are potential participants currently able to apply for enrollment in this research study?

"As per clinicaltrials.gov, recruitment for this research endeavor is currently closed. The study was first listed on 15th February 2024 and last updated on 12th February 2024. Despite the lack of availability in this trial, there are presently 201 alternative studies open for participant enrollment."

Answered by AI