Neuromodulation Treatment of Vestibular Migraines

May 24, 2019 updated by: Michael E. Hoffer, University of Miami
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami Miller School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Device
Neuromodulation
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 Names:
  • Caloric stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dizziness Handicap Inventory
Time Frame: Until study completion up to 12 months
Questionnaire of dizziness symptoms
Until study completion up to 12 months
Headache Impact Test
Time Frame: Until study completion up to 12 months
Headache questionnaire
Until study completion up to 12 months
Activities Balance Confidence Interval
Time Frame: Until study completion up to 12 months
Dizziness questionnaire
Until study completion up to 12 months
OVRT Testing
Time Frame: Until study completion up to 12 months
Oculomotor, vestibular, and reaction time tests
Until study completion up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Epworth Sleepiness Scale
Time Frame: Until study completion up to 12 months
Sleepiness questionnaire
Until study completion up to 12 months
T2 Mood Tracker app
Time Frame: Until study completion up to 12 months
App to assess mood and anxiety
Until study completion up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Collaborators

Scion NeuroStim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 28, 2016

Primary Completion (ANTICIPATED)

May 1, 2019

Study Completion (ANTICIPATED)

May 1, 2019

Study Registration Dates

First Submitted

August 5, 2016

First Submitted That Met QC Criteria

August 9, 2016

First Posted (ESTIMATE)

August 15, 2016

Study Record Updates

Last Update Posted (ACTUAL)

May 29, 2019

Last Update Submitted That Met QC Criteria

May 24, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20160566

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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