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

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).

Study Overview

• Status: Suspended
• Conditions: Confusion; Nausea; Dizziness; Headache
• Intervention / Treatment: Device: Otoband; Device: Otoband sham

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Otoband efficacy on vertigo; 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.	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.
Sham Comparator: Otoband sham efficacy on vertigo; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in vertigo symptoms	Questionnaire for vertigo symptoms from 0 (none) to 10 (agonizing)	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.	2 minutes and 20 minutes after starting the Otoband; and 20 minutes after stopping the Otoband

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in nausea symptoms	Questionnaire for nausea symptoms from 0 (none) to 10 (agonizing)	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)	2 minutes and 20 minutes after starting the Otoband; and 20 minutes after stopping the Otoband

Collaborators and Investigators

• Sponsor: Otolith Labs
• Investigators: Principal Investigator: Dennis Fitzgerald, MD, Jefferson University

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2019
• Primary Completion (Anticipated): December 30, 2021
• Study Completion (Anticipated): December 30, 2021

Study Registration Dates

• First Submitted: March 20, 2019
• First Submitted That Met QC Criteria: March 20, 2019
• First Posted (Actual): March 22, 2019

Study Record Updates

• Last Update Posted (Actual): April 27, 2021
• Last Update Submitted That Met QC Criteria: April 23, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Migraine Associated Vertigo
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Neurobehavioral Manifestations; Otorhinolaryngologic Diseases; Labyrinth Diseases; Ear Diseases; Vestibular Diseases; Sensation Disorders; Headache Disorders, Primary; Headache Disorders; Vertigo; Dizziness; Migraine Disorders; Headache; Confusion
• Other Study ID Numbers: OLith10401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No