NCT03886012

Efficacy of a Transcranial Vibrating System for Mitigation of Migraine Associated Vertigo

Efficacy of a Transcranial Vibrating System for Mitigation of Outcomes of Migraine Associated Vertigo

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Otolith Labs · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dizziness
• Nausea
• Headache
• Confusion

Interventions

Type	Name	Description
DEVICE	Otoband	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.
DEVICE	Otoband sham	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.

Timeline

• Start date: 2019-04-26
• Primary completion: 2021-12-30
• Completion: 2021-12-30
• First posted: 2019-03-22
• Last updated: 2021-04-27

Locations

1 site across 1 country: United States