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

Sponsor

Otolith Labs (Industry)

Overall Status

Suspended

CT.gov ID

NCT03886012

Collaborator

(none)

Enrollment

Location

Arms

32.2

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Dizziness Nausea Headache Confusion	Device: Otoband Device: Otoband sham	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Subjects will be given the transcranial vibrating system (the Otoband) to use when they have migraine associated vertigo (MAV). The Otoband will function for up to 4 periods of 30 minutes per day, at one of two possible pre-set power levels. The possible power levels are A) a level deemed to be effective, or B) a placebo (ineffective) power level. On a given calendar day, the power level remains constant. The sponsor will provide Otobands with a predetermined, randomly assigned power schedule based on calendar day. Subjects will use the Otoband during each MAV episode. They will fill out questionnaires about associated symptoms (dizziness, nausea, headache, brain confusion) 2 & 20 minutes after using turning the Otoband on, and 20 minutes after they stop using the Otoband. Outcomes measured will be compared between days with device at effective versus placebo power to determine if the Otoband affects dizziness, nausea, headache and brain confusion symptoms during MAV attacks.Subjects will be given the transcranial vibrating system (the Otoband) to use when they have migraine associated vertigo (MAV). The Otoband will function for up to 4 periods of 30 minutes per day, at one of two possible pre-set power levels. The possible power levels are A) a level deemed to be effective, or B) a placebo (ineffective) power level. On a given calendar day, the power level remains constant. The sponsor will provide Otobands with a predetermined, randomly assigned power schedule based on calendar day. Subjects will use the Otoband during each MAV episode. They will fill out questionnaires about associated symptoms (dizziness, nausea, headache, brain confusion) 2 & 20 minutes after using turning the Otoband on, and 20 minutes after they stop using the Otoband. Outcomes measured will be compared between days with device at effective versus placebo power to determine if the Otoband affects dizziness, nausea, headache and brain confusion symptoms during MAV attacks.

Masking:

Double (Participant, Investigator)

Masking Description:

Neither the subject nor the investigators in the study will know the calendar's schedule for normal or placebo power levels. At both settings, the device will be felt to vibrate, making it unlikely that participants will be able to guess which setting is effective and which is ineffective.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 26, 2019

Anticipated Primary Completion Date :

Dec 30, 2021

Anticipated Study Completion Date :

Dec 30, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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)
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.

Secondary Outcome Measures

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)
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

History of head injury within the last six months or currently suffering the effects of a head injury
Presence of severe aphasia
History of diagnosed neuropsychiatric disorders (e.g. hypochondriasis, major depression, schizophrenia)
Documented neurodegenerative disorders
Pregnancy [Female candidates will be asked if they are pregnant]
Prior disorders of hearing and balance including:
Ménière's disease
Multiple sclerosis
Vestibular neuritis
Vestibular schwannoma
Sudden sensorineural hearing loss
History of Cerebrovascular disorders
History of ear operation other than myringotomy and tube placement in the past
Planned major surgery of the skull base (for instance, cochlear implant)
Systemic disorders to include chronic renal failure, cirrhosis of the liver, autoimmune disease, heart disease, lung disease, or severe arthritis
Individuals who cannot provide informed consent