DizzinessNCT03886012
Efficacy of a Transcranial Vibrating System for Mitigation of Migraine Associated Vertigo
A study testing Otoband in people with Dizziness and Nausea, run by Otolith Labs at 1 site in United States.
Trial summary
Vertigo is among the most common symptoms associated with migraine and affects 26.5% of migraine sufferers, leading to a dramatic impact in life limiting even the most simple activities. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- What is being tested?
- Otoband
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2019to 30 Dec 2021
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject between the ages of 18-65 with a history of frequent Migraine Associated Vertigo (MAV) attacks as characterized by the following:
- An episode with acute onset vertigo that lasted at least 15 minutes within the previous 30 days.
- At least 5 such episodes in the past 12 months.
Who cannot join
- History of head injury within the last six months or currently suffering the effects of a head injury
- Presence of severe aphasia
- History of diagnosed neuropsychiatric disorders (e.g. hypochondriasis, major depression, schizophrenia)
- Documented neurodegenerative disorders
- Pregnancy [Female candidates will be asked if they are pregnant]
- Prior disorders of hearing and balance including:
Show all 16Show fewer
- Ménière's disease
- Multiple sclerosis
- Vestibular neuritis
- Vestibular schwannoma
- Sudden sensorineural hearing loss
- History of Cerebrovascular disorders
- History of ear operation other than myringotomy and tube placement in the past
- Planned major surgery of the skull base (for instance, cochlear implant)
- Systemic disorders to include chronic renal failure, cirrhosis of the liver, autoimmune disease, heart disease, lung disease, or severe arthritis
- Individuals who cannot provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: Efficacy of a Transcranial Vibrating System for Mitigation of Outcomes of Migraine Associated Vertigo
Vertigo is among the most common symptoms associated with migraine and affects 26.5% of migraine sufferers, leading to a dramatic impact in life limiting even the most simple activities. A new device, the OtoBand, a transcranial vibrating system, has been shown to mitigate and sometimes prevent vertigo and nausea in healthy subjects. The current study aims to determine if the Otoband can treat or reduce symptoms of Migraine Associated Vertigo (MAV).
Read the detailed description
Vertigo is among the most common symptoms associated with migraine and affects 26.5% of migraine sufferers. Migraine Associated Vertigo (MAV) has a dramatic impact on daily life, impacting work, relationships, and even activities of daily living. At the current time, the mainstay of therapy for migraine is pharmaceutical intervention, either acute (particularly triptans, 2) or preventative. However, this therapy has a delayed effect and can lead to a host of side effects.
In this project we examine a device that has shown promise and might be beneficial for treating or improving the course of recovery from MAV. The Otoband is a transcranial vibrating system to be placed against the skull, preferably over the mastoid bone, behind the ear. To date, the device has only been systematically tested on healthy volunteers and has shown improvement of vertigo symptoms during the use of virtual reality systems and road motion sickness.
Individuals identified at Jefferson University medical center with a history of MAV attacks will be referred to the Otolaryngology Department where their diagnosis will be confirmed and offered to enroll in the study. Participants will be able to take home an Otoband to wear when they have MAV attacks. The Otoband will be set at the effective power (proved to reduce vertigo symptoms in previous studies) and low power (proved to not impact vertigo symptoms, considered as sham device). Participants will have to assay their vertigo symptoms before, during and immediately after wearing the Otoband to evaluate the efficacy of the device.
- Being tested
- Otoband, Otoband sham
- Keywords
- Migraine Associated Vertigo
- Medical subject headings
- Dizziness, Nausea, Headache, Confusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OtobandDevice
The Otoband will be used by participants during migraine associated vertigo (MAV). We expect the research subjects to use the device for at least 20 minutes, with the hardware limiting any one session to a duration of 30 minutes, up to 4 times per calendar day. The Otoband will be set to the effective power level during the course of a given calendar day.
Otoband shamDevice
The Otoband will be used by participants during migraine associated vertigo (MAV) for a maximum of 30 minutes, up to 4 times per calendar day. The Otoband will be set to an ineffective power level (considered a sham device) during the course of a given calendar day.
| Study group | Role | What they receive |
|---|---|---|
| Otoband efficacy on vertigo | Experimental | Participants will be given the transcranial vibrating system (Otoband) to be used during migrane associated vertigo (MAV) attacks. Participants will be able to use the Otoband up to 4 times, 30 minutes each time, per day. The Otoband will be set to the effective power level. Participants will fill out questionnaires about 4 symptoms associated to MAV: before, during (2 and 20 minutes after turning on the Otoband) and after the session (20 minutes after the Otoband was or has stopped). The conditions evaluated will be: dizziness, nausea, headache and brain confusion.
Participants will complete questionnaires either online using secure HIPPA-compliant webforms, or using pre-printed questionnaires, as they prefer. Receives: Device: Otoband |
| Otoband sham efficacy on vertigo | Sham comparator | Participants will be given the transcranial vibrating system (Otoband) to be used during migrane associated vertigo (MAV) attacks. Participants will be able to use the Otoband up to 4 times, 30 minutes each time, per day. The Otoband will be set to an ineffective power level, serving as a placebo. Participants will fill out questionnaires about 4 symptoms associated to MAV: before, during (2 and 20 minutes after turning on the Otoband) and after the session (20 minutes after the Otoband was or has stopped). The conditions evaluated will be: dizziness, nausea, headache and brain confusion.
Participants will complete questionnaires either online using secure HIPPA-compliant webforms, or using pre-printed questionnaires, as they prefer. Receives: Device: Otoband sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in vertigo symptoms
Questionnaire for vertigo symptoms from 0 (none) to 10 (agonizing)
Measured: 2 minutes and 20 minutes after starting the Otoband; and 20 minutes after stopping the Otoband
Brain confusion
Questionnaire for brain confusion: scale from 0 (none) to 10 (maximum) for the 4 following symptoms: forgetful, difficulty thinking/finding words, difficulty focusing, cloudy.
Measured: 2 minutes and 20 minutes after starting the Otoband; and 20 minutes after stopping the Otoband
Secondary outcomes (2)
Change in nausea symptoms
Questionnaire for nausea symptoms from 0 (none) to 10 (agonizing)
Measured: 2 minutes and 20 minutes after starting the Otoband; and 20 minutes after stopping the Otoband
Change in headache symptoms
Questionnaire for nausea symptoms from 0 (none) to 10 (worst pain possible)
Measured: 2 minutes and 20 minutes after starting the Otoband; and 20 minutes after stopping the Otoband
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study start26 Apr 2019
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Why it stopped: COVID-19 general concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DizzinessStudies 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
- Crossover
- Model description
- Subjects will be given the transcranial vibrating system (the Otoband) to use when they have migraine associated vertigo (MAV). The Otoband will function for up to 4 periods of 30 minutes per day, at one of two possible pre-set power levels. The possible power levels are A) a level deemed to be effective, or B) a placebo (ineffective) power level. On a given calendar day, the power level remains constant. The sponsor will provide Otobands with a predetermined, randomly assigned power schedule based on calendar day. Subjects will use the Otoband during each MAV episode. They will fill out questionnaires about associated symptoms (dizziness, nausea, headache, brain confusion) 2 \& 20 minutes after using turning the Otoband on, and 20 minutes after they stop using the Otoband. Outcomes measured will be compared between days with device at effective versus placebo power to determine if the Otoband affects dizziness, nausea, headache and brain confusion symptoms during MAV attacks.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Otolith Labs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dennis Fitzgerald, MD, Principal investigator, Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03886012
- Sponsor's protocol ID
- OLith10401
- Status last verified
- Apr 2021
- First submitted
- 20 Mar 2019
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Transcranial Vibrating System for Mitigation of Outcomes of Migraine Associated Vertigo
- ClinicalTrials.gov ID
- NCT03886012
- Acronym / sponsor ID
- OLith10401
- Keywords
- Migraine Associated Vertigo
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: COVID-19 general concerns.
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Otolith LabsIndustry (pharma, biotech, devices)
- Study start
- 26 Apr 2019 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 22 Mar 2019 (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.
Vertigo is among the most common symptoms associated with migraine and affects 26.5% of migraine sufferers, leading to a dramatic impact in life limiting even the most simple activities. A new device, the OtoBand, a transcranial vibrating system, has been shown to mitigate and sometimes prevent vertigo and nausea in healthy subjects. The current study aims to determine if the Otoband can treat or reduce symptoms of Migraine Associated Vertigo (MAV).
Detailed description
Vertigo is among the most common symptoms associated with migraine and affects 26.5% of migraine sufferers. Migraine Associated Vertigo (MAV) has a dramatic impact on daily life, impacting work, relationships, and even activities of daily living. At the current time, the mainstay of therapy for migraine is pharmaceutical intervention, either acute (particularly triptans, 2) or preventative. However, this therapy has a delayed effect and can lead to a host of side effects.
In this project we examine a device that has shown promise and might be beneficial for treating or improving the course of recovery from MAV. The Otoband is a transcranial vibrating system to be placed against the skull, preferably over the mastoid bone, behind the ear. To date, the device has only been systematically tested on healthy volunteers and has shown improvement of vertigo symptoms during the use of virtual reality systems and road motion sickness.
Individuals identified at Jefferson University medical center with a history of MAV attacks will be referred to the Otolaryngology Department where their diagnosis will be confirmed and offered to enroll in the study. Participants will be able to take home an Otoband to wear when they have MAV attacks. The Otoband will be set at the effective power (proved to reduce vertigo symptoms in previous studies) and low power (proved to not impact vertigo symptoms, considered as sham device). Participants will have to assay their vertigo symptoms before, during and immediately after wearing the Otoband to evaluate the efficacy of the device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Subjects will be given the transcranial vibrating system (the Otoband) to use when they have migraine associated vertigo (MAV). The Otoband will function for up to 4 periods of 30 minutes per day, at one of two possible pre-set power levels. The possible power levels are A) a level deemed to be effective, or B) a placebo (ineffective) power level. On a given calendar day, the power level remains constant. The sponsor will provide Otobands with a predetermined, randomly assigned power schedule based on calendar day. Subjects will use the Otoband during each MAV episode. They will fill out questionnaires about associated symptoms (dizziness, nausea, headache, brain confusion) 2 \& 20 minutes after using turning the Otoband on, and 20 minutes after they stop using the Otoband. Outcomes measured will be compared between days with device at effective versus placebo power to determine if the Otoband affects dizziness, nausea, headache and brain confusion symptoms during MAV attacks.
| Arm | Type | Receives |
|---|---|---|
| Otoband efficacy on vertigo | Experimental | Device: OtobandParticipants will be given the transcranial vibrating system (Otoband) to be used during migrane associated vertigo (MAV) attacks. Participants will be able to use the Otoband up to 4 times, 30 minutes each time, per day. The Otoband will be set to the effective power level. Participants will fill out questionnaires about 4 symptoms associated to MAV: before, during (2 and 20 minutes after turning on the Otoband) and after the session (20 minutes after the Otoband was or has stopped). The conditions evaluated will be: dizziness, nausea, headache and brain confusion. Participants will complete questionnaires either online using secure HIPPA-compliant webforms, or using pre-printed questionnaires, as they prefer. |
| Otoband sham efficacy on vertigo | Sham comparator | Device: Otoband shamParticipants will be given the transcranial vibrating system (Otoband) to be used during migrane associated vertigo (MAV) attacks. Participants will be able to use the Otoband up to 4 times, 30 minutes each time, per day. The Otoband will be set to an ineffective power level, serving as a placebo. Participants will fill out questionnaires about 4 symptoms associated to MAV: before, during (2 and 20 minutes after turning on the Otoband) and after the session (20 minutes after the Otoband was or has stopped). The conditions evaluated will be: dizziness, nausea, headache and brain confusion. Participants will complete questionnaires either online using secure HIPPA-compliant webforms, or using pre-printed questionnaires, as they prefer. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject between the ages of 18-65 with a history of frequent Migraine Associated Vertigo (MAV) attacks as characterized by the following:
- An episode with acute onset vertigo that lasted at least 15 minutes within the previous 30 days.
- At least 5 such episodes in the past 12 months.
Key exclusion criteria (16 listed)
- History of head injury within the last six months or currently suffering the effects of a head injury
- Presence of severe aphasia
- History of diagnosed neuropsychiatric disorders (e.g. hypochondriasis, major depression, schizophrenia)
- Documented neurodegenerative disorders
- Pregnancy [Female candidates will be asked if they are pregnant]
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 |
|---|---|---|
| OtobandThe Otoband will be used by participants during migraine associated vertigo (MAV). We expect the research subjects to use the device for at least 20 minutes, with the hardware limiting any one session to a duration of 30 minutes, up to 4 times per calendar day. The Otoband will be set to the effective power level during the course of a given calendar day. | Device | Otoband efficacy on vertigo |
| Otoband shamThe Otoband will be used by participants during migraine associated vertigo (MAV) for a maximum of 30 minutes, up to 4 times per calendar day. The Otoband will be set to an ineffective power level (considered a sham device) during the course of a given calendar day. | Device | Otoband sham efficacy on vertigo |
Primary outcome
Change in vertigo symptoms
Time frame: 2 minutes and 20 minutes after starting the Otoband; and 20 minutes after stopping the Otoband
Questionnaire for vertigo symptoms from 0 (none) to 10 (agonizing)
Brain confusion
Time frame: 2 minutes and 20 minutes after starting the Otoband; and 20 minutes after stopping the Otoband
Questionnaire for brain confusion: scale from 0 (none) to 10 (maximum) for the 4 following symptoms: forgetful, difficulty thinking/finding words, difficulty focusing, cloudy.
2 secondary outcomes
Change in nausea symptoms
Time frame: 2 minutes and 20 minutes after starting the Otoband; and 20 minutes after stopping the Otoband
Change in headache symptoms
Time frame: 2 minutes and 20 minutes after starting the Otoband; and 20 minutes after stopping the Otoband
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Individual participant dataSharing planned: No
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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.
Dennis Fitzgerald, MD principal investigator
Jefferson University
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 in people with Dizziness and Nausea, 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 3 inclusion and 16 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: paused, as of the sponsor's last update on 27 Apr 2021. 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?
Results are not available in the source record.
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?
Change in vertigo symptoms (time frame: 2 minutes and 20 minutes after starting the Otoband; and 20 minutes after stopping the Otoband). The study lists 2 primary outcomes in all. 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 27 Apr 2021.