Ignite Creation Date:
2024-05-06 @ 12:56 PM
Last Modification Date:
2024-10-26 @ 1:06 PM
Study NCT ID:
NCT03886012
Status:
SUSPENDED
Last Update Posted:
2021-04-27
First Post:
2019-03-20
Brief Title:
Efficacy of a Transcranial Vibrating System for Mitigation of Migraine Associated Vertigo
Sponsor:
Otolith Labs
Organization:
Otolith Labs
Study Overview
Official Title:
Efficacy of a Transcranial Vibrating System for Mitigation of Outcomes of Migraine Associated Vertigo
Status:
SUSPENDED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
COVID-19 general concerns
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Vertigo is among the most common symptoms associated with migraine and affects 265 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 265 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None