Clinical trial NCT03886012: Efficacy of a Transcranial Vibrating System for Mitigation of Migraine Associated Vertigo
Official title: Efficacy of a Transcranial Vibrating System for Mitigation of Outcomes of Migraine Associated Vertigo
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Dizziness
Nausea
Headache
Confusion
Keywords: Migraine Associated Vertigo
Lead sponsor: Otolith Labs
Sponsor class: INDUSTRY
First posted: 2019-03-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

1. History of head injury within the last six months or currently suffering the effects of a head injury
2. Presence of severe aphasia
3. History of diagnosed neuropsychiatric disorders (e.g. hypochondriasis, major depression, schizophrenia)
4. Documented neurodegenerative disorders
5. Pregnancy \[Female candidates will be asked if they are pregnant\]
6. Prior disorders of hearing and balance including:

   1. Ménière's disease
   2. Multiple sclerosis
   3. Vestibular neuritis
   4. Vestibular schwannoma
   5. Sudden sensorineural hearing loss
7. History of Cerebrovascular disorders
8. History of ear operation other than myringotomy and tube placement in the past
9. Planned major surgery of the skull base (for instance, cochlear implant)
10. Systemic disorders to include chronic renal failure, cirrhosis of the liver, autoimmune disease, heart disease, lung disease, or severe arthritis
11. Individuals who cannot provide informed consent

Primary outcomes:
measure: Change in vertigo symptoms
timeFrame: 2 minutes and 20 minutes after starting the Otoband; and 20 minutes after stopping the Otoband
measure: Brain confusion
timeFrame: 2 minutes and 20 minutes after starting the Otoband; and 20 minutes after stopping the Otoband
Secondary outcomes:
measure: Change in nausea symptoms
timeFrame: 2 minutes and 20 minutes after starting the Otoband; and 20 minutes after stopping the Otoband
measure: Change in headache symptoms
timeFrame: 2 minutes and 20 minutes after starting the Otoband; and 20 minutes after stopping the Otoband
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson Hospital
state: Pennsylvania
Study officials:
affiliation: Jefferson University
name: Dennis Fitzgerald, MD
role: PRINCIPAL_INVESTIGATOR
References: