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

Primary Purpose

Dizziness, Nausea, Headache

Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Otoband
Otoband sham
Sponsored by
Otolith Labs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dizziness focused on measuring Migraine Associated Vertigo

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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:

  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

Sites / Locations

  • Thomas Jefferson Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Otoband efficacy on vertigo

Otoband sham efficacy on vertigo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in vertigo symptoms
Questionnaire for vertigo symptoms from 0 (none) to 10 (agonizing)
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.

Secondary Outcome Measures

Change in nausea symptoms
Questionnaire for nausea symptoms from 0 (none) to 10 (agonizing)
Change in headache symptoms
Questionnaire for nausea symptoms from 0 (none) to 10 (worst pain possible)

Full Information

First Posted
March 20, 2019
Last Updated
April 23, 2021
Sponsor
Otolith Labs
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1. Study Identification

Unique Protocol Identification Number
NCT03886012
Brief Title
Efficacy of a Transcranial Vibrating System for Mitigation of Migraine Associated Vertigo
Official Title
Efficacy of a Transcranial Vibrating System for Mitigation of Outcomes of Migraine Associated Vertigo
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Suspended
Why Stopped
COVID-19 general concerns.
Study Start Date
April 26, 2019 (Actual)
Primary Completion Date
December 30, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otolith Labs

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dizziness, Nausea, Headache, Confusion
Keywords
Migraine Associated Vertigo

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
ParticipantInvestigator
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.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Otoband efficacy on vertigo
Arm Type
Experimental
Arm Description
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.
Arm Title
Otoband sham efficacy on vertigo
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Otoband
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Otoband sham
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in vertigo symptoms
Description
Questionnaire for vertigo symptoms from 0 (none) to 10 (agonizing)
Time Frame
2 minutes and 20 minutes after starting the Otoband; and 20 minutes after stopping the Otoband
Title
Brain confusion
Description
Questionnaire for brain confusion: scale from 0 (none) to 10 (maximum) for the 4 following symptoms: forgetful, difficulty thinking/finding words, difficulty focusing, cloudy.
Time Frame
2 minutes and 20 minutes after starting the Otoband; and 20 minutes after stopping the Otoband
Secondary Outcome Measure Information:
Title
Change in nausea symptoms
Description
Questionnaire for nausea symptoms from 0 (none) to 10 (agonizing)
Time Frame
2 minutes and 20 minutes after starting the Otoband; and 20 minutes after stopping the Otoband
Title
Change in headache symptoms
Description
Questionnaire for nausea symptoms from 0 (none) to 10 (worst pain possible)
Time Frame
2 minutes and 20 minutes after starting the Otoband; and 20 minutes after stopping the Otoband

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis Fitzgerald, MD
Organizational Affiliation
Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomas Jefferson Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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