Vestibular MigraineNCT06267924
SENSE-VM: Safety and Effectiveness of a Novel Medical Device for Symptom Ease in Vestibular Migraines
A study testing Otoband Experimental in people with Vestibular Migraine and Migraine Associated Vertigo, run by Otolith Labs at 1 site in United States.
Trial summary
The goal of this virtual clinical trial is to compare the effectiveness of two study devices in providing temporary relief to adults aged 18-75 who suffer from symptoms of chronic Vestibular Migraines (VM), also known as Migraine Associated Vertigo. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Vestibular Migraine, Migraine Associated Vertigo
- What is being tested?
- Otoband Experimental
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 322 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2024to 8 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be eligible to participate in this study, an individual must meet all the following criteria:
- Diagnosed as having Vestibular Migraine (VM) (aka Migraine Associated Vertigo) The participant's diagnosis must be provided by a physician, Board certified in Otolaryngology or Neurology, from one of the study's approved clinics.
- Diagnosis for VM must follow Bárány Society's "International Classification of Vestibular Disorders", which contains the Society's consensus diagnostic criteria for VM [Lempert 2022, sect. 3].
- Male or female subjects, age 18 to 75 years old inclusive on day of enrollment
- Residing in the United States
- Vestibular migraines that have been recurrent for at least 90 days
Show all 10Show fewer
- Score from 36 to 90 inclusive on the Dizziness Handicap Inventory (DHI) (corresponding to moderate to severe vertigo)
- A smartphone, computer or tablet and access to internet to complete study procedures and study meetings
- Willing and able to comply with study procedures
- Willingness to use Venmo or Paypal for study stipend
Who cannot join
- Females who are pregnant or trying to become pregnant
- Enrolled in previous Otolith Lab-sponsored clinical trial
- Currently taking part in another interventional trial
- Surgery to the skull base within the last 6 months or plans for surgery to the skull during enrollment period
- Skull or neck implants
- History of vitreous detachment in the last 90 days
Show all 14Show fewer
- Superior canal dehiscence or otic capsule dehiscence
- Diagnosed hyperacusis
- Planning to start vestibular rehabilitation therapy during the study
- History of cerebrovascular disorders
- Posterior fossa tumors, vestibular schwannoma
- Cerebellar degeneration (progressive worsening of neurons behind the brain stem)
- Initiation of calcitonin gene-related peptide inhibitor treatment within 4 weeks prior to beginning of trial
- Cognitive impairment or inability to follow study procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
Otolith Labs
Washington D.C., District of Columbia, 20001
About this study
The goal of this virtual clinical trial is to compare the effectiveness of two study devices in providing temporary relief to adults aged 18-75 who suffer from symptoms of chronic Vestibular Migraines (VM), also known as Migraine Associated Vertigo.
Participants will be:
Read more
- Enrolled up to 50 days; enrollment, 14 days in Baseline Phase (no device), 7 days in Transition Phase, 28 days in Treatment Phase (study device)
- Randomized and stratified into groups based on the referring clinic to be assigned one study device
- Asked to use the study device as instructed by the study coordinator
- Asked to submit daily diaries reporting their symptoms and use of device, and to participate in tele-health visits with study coordinators
- Asked to provide their vertigo diagnosis from their physician
- Compensated for their participation
Researchers will compare the randomized groups to determine which group responds better to which device.
Read the detailed description
This study is a decentralized clinical trial. This study uses technology and virtual meetings to communicate with study participants and collect study data. This study seeks to enroll until 200 participants have completed the study per protocol.
Study participants that meet all of the inclusion, none of the exclusion criteria, and sign the informed consent form will be enrolled in the study. Participants will complete a one day enrollment meeting and a 14 day Baseline Phase.
If a participant is eligible to remain in the study for the Treatment Phase at day 15, they will be randomized within their assigned group at a 1:1 ratio to an Active arm or Sham arm to begin the Treatment Phase of the study. Participants will be sent a study device to use when they have a vertigo episode.
Participants that enroll in the study are expected to participate up to 50 days with virtual meetings at the approximate intervals:
Day 5, Day 15, Day 22, Day 25, Day 35, and Day 51
Participants will be required to complete the DHI (Dizziness Handicap Inventory), VM-PATHI (Vestibular Migraine Patient Assessment Tool and Handicap Inventory), General Vertigo History, Global Impression of Change, "Most Bothersome Symptom", Relief from "Most Bothersome Symptom", and Net promoter score questionnaires.
Otolith Labs received Therapeutic Breakthrough Device designation by the FDA in May 2021.
- Conditions
- Vestibular Migraine, Migraine Associated Vertigo
- Being tested
- Otoband Experimental, Otoband Sham
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Otoband ExperimentalDevice
Participants will be randomly assigned to use the Otoband Experimental device to determine effectiveness in providing temporary relief to symptoms of vertigo.
Otoband ShamDevice
Participants will be randomly assigned to use the Otoband Sham device to determine effectiveness in providing temporary relief to symptoms of vertigo.
| Study group | Role | What they receive |
|---|---|---|
| 1. Moderate or Worse (MoW) Arm | Experimental | Participants will be randomized to use the Otoband as instructed by clinical coordinator per study protocol. These participants will receive the experimental treatment device. Receives: Device: Otoband Experimental |
| 2. Moderate or Worse (MoW) Arm | Sham comparator | Participants will be randomized to use the Otoband as instructed by clinical coordinator per study protocol. These participants will receive the sham device. Receives: Device: Otoband Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
DHI Change in Scores
Reduction in final "Dizziness Handicap Inventory" (DHI) score by at least 12 points, compared to transition DHI score
Measured: Day 23 - Day 51
Secondary outcomes (5)
Number of related adverse events
Assessment of any adverse events related to device usage
Measured: Day 23 - Day 51
Change in number of vestibular migraine episodes weekly
Assessment of the number of vestibular migraine episodes each week
Measured: Day 1 - Day 51
Global Impression of Change (severity of episodes)
Assessment of the results of Global Impression of Change questionnaire and impacts on the severity of episodes
Measured: Day 51
DHI change from transition to end of study
Assessment of overall changes in DHI score from transition time point to the end of the study
Measured: Day 23 - Day 51
Device responder rate
Assessment of the responder rate of the study arms and their device usage
Measured: Day 23 - Day 51
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start6 Mar 2024
- Primary completion9 Dec 2024
- Study completion8 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The proposed clinical trial for the study device will be a randomized, sham-controlled, double-blind study with two-parallel arms (active/sham device).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 322 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otolith Labs
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MCRA
- Responsible party
- Sponsor
- Investigators
- Didier Depireux, PhD, Principal investigator, Otolith Labs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06267924
- Sponsor's protocol ID
- Olith10703
- Status last verified
- Jan 2025
- First submitted
- 12 Feb 2024
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: De-identified data will be made available to other researchers in an aggregate fashion upon publication of this study.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SENSE-VM: Safety and Effectiveness of a Novel Medical Device for Symptom Ease in Vestibular Migraines
- ClinicalTrials.gov ID
- NCT06267924
- Acronym / sponsor ID
- Olith10703
- Conditions
- Vestibular Migraine, Migraine Associated Vertigo
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 322 participants (actual)
- Lead sponsor
- Otolith LabsIndustry (pharma, biotech, devices)
- Collaborators
- MCRA
- Study start
- 6 Mar 2024 (actual)
- Primary completion
- 9 Dec 2024 (actual)
- Study completion
- 8 Jan 2025 (actual)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this virtual clinical trial is to compare the effectiveness of two study devices in providing temporary relief to adults aged 18-75 who suffer from symptoms of chronic Vestibular Migraines (VM), also known as Migraine Associated Vertigo.
Participants will be:
- Enrolled up to 50 days; enrollment, 14 days in Baseline Phase (no device), 7 days in Transition Phase, 28 days in Treatment Phase (study device)
- Randomized and stratified into groups based on the referring clinic to be assigned one study device
- Asked to use the study device as instructed by the study coordinator
- Asked to submit daily diaries reporting their symptoms and use of device, and to participate in tele-health visits with study coordinators
- Asked to provide their vertigo diagnosis from their physician
- Compensated for their participation
Researchers will compare the randomized groups to determine which group responds better to which device.
Detailed description
This study is a decentralized clinical trial. This study uses technology and virtual meetings to communicate with study participants and collect study data. This study seeks to enroll until 200 participants have completed the study per protocol.
Study participants that meet all of the inclusion, none of the exclusion criteria, and sign the informed consent form will be enrolled in the study. Participants will complete a one day enrollment meeting and a 14 day Baseline Phase.
If a participant is eligible to remain in the study for the Treatment Phase at day 15, they will be randomized within their assigned group at a 1:1 ratio to an Active arm or Sham arm to begin the Treatment Phase of the study. Participants will be sent a study device to use when they have a vertigo episode.
Participants that enroll in the study are expected to participate up to 50 days with virtual meetings at the approximate intervals:
Day 5, Day 15, Day 22, Day 25, Day 35, and Day 51
Participants will be required to complete the DHI (Dizziness Handicap Inventory), VM-PATHI (Vestibular Migraine Patient Assessment Tool and Handicap Inventory), General Vertigo History, Global Impression of Change, "Most Bothersome Symptom", Relief from "Most Bothersome Symptom", and Net promoter score questionnaires.
Otolith Labs received Therapeutic Breakthrough Device designation by the FDA in May 2021.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The proposed clinical trial for the study device will be a randomized, sham-controlled, double-blind study with two-parallel arms (active/sham device).
| Arm | Type | Receives |
|---|---|---|
| 1. Moderate or Worse (MoW) Arm | Experimental | Device: Otoband ExperimentalParticipants will be randomized to use the Otoband as instructed by clinical coordinator per study protocol. These participants will receive the experimental treatment device. |
| 2. Moderate or Worse (MoW) Arm | Sham comparator | Device: Otoband ShamParticipants will be randomized to use the Otoband as instructed by clinical coordinator per study protocol. These participants will receive the sham device. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- To be eligible to participate in this study, an individual must meet all the following criteria:
- Diagnosed as having Vestibular Migraine (VM) (aka Migraine Associated Vertigo) The participant's diagnosis must be provided by a physician, Board certified in Otolaryngology or Neurology, from one of the study's approved clinics.
- Diagnosis for VM must follow Bárány Society's "International Classification of Vestibular Disorders", which contains the Society's consensus diagnostic criteria for VM [Lempert 2022, sect. 3].
- Male or female subjects, age 18 to 75 years old inclusive on day of enrollment
- Residing in the United States
Key exclusion criteria (14 listed)
- Females who are pregnant or trying to become pregnant
- Enrolled in previous Otolith Lab-sponsored clinical trial
- Currently taking part in another interventional trial
- Surgery to the skull base within the last 6 months or plans for surgery to the skull during enrollment period
- Skull or neck implants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Otoband ExperimentalParticipants will be randomly assigned to use the Otoband Experimental device to determine effectiveness in providing temporary relief to symptoms of vertigo. | Device | 1. Moderate or Worse (MoW) Arm |
| Otoband ShamParticipants will be randomly assigned to use the Otoband Sham device to determine effectiveness in providing temporary relief to symptoms of vertigo. | Device | 2. Moderate or Worse (MoW) Arm |
Primary outcome
DHI Change in Scores
Time frame: Day 23 - Day 51
Reduction in final "Dizziness Handicap Inventory" (DHI) score by at least 12 points, compared to transition DHI score
5 secondary outcomes
Number of related adverse events
Time frame: Day 23 - Day 51
Change in number of vestibular migraine episodes weekly
Time frame: Day 1 - Day 51
Global Impression of Change (severity of episodes)
Time frame: Day 51
DHI change from transition to end of study
Time frame: Day 23 - Day 51
Device responder rate
Time frame: Day 23 - Day 51
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Individual participant dataSharing planned: No. De-identified data will be made available to other researchers in an aggregate fashion upon publication of this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Didier Depireux, PhD principal investigator
Otolith Labs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Otoband Experimental in people with Vestibular Migraine and Migraine Associated Vertigo, run by Otolith Labs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DHI Change in Scores (time frame: Day 23 - Day 51). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.