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Neuromodulation Treatment of Vestibular Migraines

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. Read our disclaimer for details. Identifier: NCT02866084
Recruitment Status : Withdrawn
First Posted : August 15, 2016
Last Update Posted : May 29, 2019
Scion NeuroStim
Information provided by (Responsible Party):
Michael E. Hoffer, University of Miami

Brief Summary:
This is a non-randomized pilot study to test the efficacy of neuromodulation via caloric stimulation on vestibular migraines. All subject who meet the study criteria will be in an active treatment group. All subjects will report the frequency of the migraines and undergo periodic testing of symptoms.

Condition or disease Intervention/treatment Phase
Headache Device: Device Not Applicable

Detailed Description:

This is a non-blinded, non-randomized pilot study of individuals with vestibular migraines. The goal is to test the efficacy of neuromodulation on both migraine and dizziness symptoms in patients with documented vestibular migraines. Treatment will consist of 9 months of active treatment followed by 3 months of observation. The active treatment requires two daily 20 minute sessions wearing a device over the ears that delivers a very small amount of warm air to the ears. All subjects will undergo a series of tests at baseline and at discrete intervals during the 1 year of observation.

Primary and Secondary endpoints are listed below:• Primary Efficacy Endpoints

  1. Reduction in the frequency and severity of migraine headaches (self reported in pain diary)
  2. Reduction in the frequency and intensity of perceived vestibular symptoms (Dizziness Handicap Inventory (DHI), Activity Balance confidence scale (ABC), Oscillopsia Test, Symptoms questionnaire), OVRT Goggle profile.

Secondary Efficacy Endpoints for the Pilot Study

  1. Improvement in sleep quality and/or quantity as assessed by the Epworth Sleep Scale.
  2. Improvement in quality of life as assessed by the HIT-6 survey.
  3. Improvement in mood/anxiety as assessed with the T2 Mood Tracker app (National Center for Telehealth & Technology).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neuromodulation Treatment of Vestibular Migraines
Actual Study Start Date : September 28, 2016
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Device
Device: Device

The following parameters will be set for active treatments using the CVS Device:

  • A standardized CVS time-varying waveform lasting approximately 19 minutes will be used. Treatments will be administered up to twice daily. The two daily treatments should ideally be separated by at least one hour.
  • The waveform schedule will consist of a warm sawtooth delivered to one ear and a cold sawtooth delivered to the other ear. The warm sawtooth will go from body temperature to 42 °C, and the cold sawtooth will go from body temperature to 17 °C. The two waveforms will be delivered simultaneously, but will have different oscillation frequencies.
Other Name: Caloric stimulation

Primary Outcome Measures :
  1. Dizziness Handicap Inventory [ Time Frame: Until study completion up to 12 months ]
    Questionnaire of dizziness symptoms

  2. Headache Impact Test [ Time Frame: Until study completion up to 12 months ]
    Headache questionnaire

  3. Activities Balance Confidence Interval [ Time Frame: Until study completion up to 12 months ]
    Dizziness questionnaire

  4. OVRT Testing [ Time Frame: Until study completion up to 12 months ]
    Oculomotor, vestibular, and reaction time tests

Secondary Outcome Measures :
  1. Epworth Sleepiness Scale [ Time Frame: Until study completion up to 12 months ]
    Sleepiness questionnaire

  2. T2 Mood Tracker app [ Time Frame: Until study completion up to 12 months ]
    App to assess mood and anxiety

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Adults, between the ages of 18 and 75 who have been diagnosed with VM least 3 months prior to entering into the study.
  2. The Investigator must have confidence in the patient's ability to reliably use the CVS Device and complete the requirements of the study.

Exclusion Criteria:

  1. are pregnant
  2. have a history of cardiovascular disease
  3. work night shifts
  4. have a history of unstable mood disorder or unstable anxiety disorder
  5. use a hearing aid
  6. have a cochlear implant
  7. abuse alcohol or other drugs
  8. are experiencing Medication Overuse Headaches (individuals with respect to whom the Investigator is concerned that analgesic abuse is involved based on the ICHD-II guidelines).
  9. have had eye surgery within the previous three months or ear surgery within the previous six months
  10. have active ear infections or a perforated tympanic membrane
  11. have participated in another clinical trial within the last 30 days or are currently enrolled in another clinical trial

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 identifier (NCT number): NCT02866084

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United States, Florida
University of Miami Miller School of Medicine
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Scion NeuroStim

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Responsible Party: Michael E. Hoffer, Professor, University of Miami Identifier: NCT02866084     History of Changes
Other Study ID Numbers: 20160566
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 Michael E. Hoffer, University of Miami:
vestibular migraines
migraine headache

Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms