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

Not Applicable

Suspended

• Conditions: Dizziness; Confusion; Nausea; Headache
• Interventions: Device: Otoband; Device: Otoband sham

• Registration Number: NCT03886012
• Lead Sponsor: Otolith Labs

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.

Study Timeline

• Study First Submitted: 2019-03-20
• Study First Submitted QC: 2019-03-20
• Study First Posted: 2019-03-22
• Study Start: 2019-04-26
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-23
• Last Update Posted: 2021-04-27
• Primary Completion: 2021-12-30
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Otoband efficacy on vertigo	Otoband	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.
Otoband sham efficacy on vertigo	Otoband sham	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.

Primary Outcome Measures

Name	Time	Method
Brain confusion	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.
Change in vertigo symptoms	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)

Secondary Outcome Measures

Name	Time	Method
Change in headache symptoms	2 minutes and 20 minutes after starting the Otoband; and 20 minutes after stopping the Otoband	Questionnaire for nausea symptoms from 0 (none) to 10 (worst pain possible)
Change in nausea symptoms	2 minutes and 20 minutes after starting the Otoband; and 20 minutes after stopping the Otoband	Questionnaire for nausea symptoms from 0 (none) to 10 (agonizing)

Trial Locations

Locations (1)

Thomas Jefferson Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States