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

Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03886012
• Other study ID #: OLith10401
• Status: Suspended
• Phase: N/A
• Start date: April 26, 2019
• Est. completion date: December 30, 2021

Study information

• Verified date: April 2021
• Source: Otolith Labs
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 40
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Confusion
• Dizziness
• Headache
• Migraine Disorders
• Nausea
• Vertigo

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Thomas Jefferson Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Otolith Labs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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