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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03886012
Recruitment Status : Recruiting
First Posted : March 22, 2019
Last Update Posted : April 29, 2019
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Dizziness Nausea Headache Confusion Device: Otoband Device: Otoband sham Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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.

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 : April 26, 2019
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Change in vertigo symptoms [ Time Frame: 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)

  2. Brain confusion [ Time Frame: 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 :
  1. Change in nausea symptoms [ Time Frame: 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)

  2. Change in headache symptoms [ Time Frame: 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03886012


Contacts
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Contact: Didier Depireux, PhD 410-925-6546 didier+jefferson@otolithlabs.com
Contact: Dana N Tango, MPH 215-503-8684 Dana.Tango@jefferson.edu

Locations
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United States, Pennsylvania
Thomas Jefferson Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Dennis Fitzgerald, MD    215-955-6760    Dana.Tango@jefferson.edu   
Contact: Beth Duddy, RN, BSN, CCRC, ACRP-PM    215-955-9880    Elizabeth.Duddy@jefferson.edu   
Principal Investigator: Dennis Fitzgerald, MD         
Sponsors and Collaborators
Otolith Labs
Investigators
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Principal Investigator: Dennis Fitzgerald, MD Jefferson University
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Responsible Party: Otolith Labs
ClinicalTrials.gov Identifier: NCT03886012    
Other Study ID Numbers: OLith10401
First Posted: March 22, 2019    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Otolith Labs:
Migraine Associated Vertigo
Additional relevant MeSH terms:
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Vertigo
Migraine Disorders
Confusion
Headache
Dizziness
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurobehavioral Manifestations