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HeadacheNCT02866084

Neuromodulation Treatment of Vestibular Migraines

A study testing Device in people with Headache, run by University of Miami at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Headache
What is being tested?
Device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
28 Sep 2016to May 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • are pregnant
  • have a history of cardiovascular disease
  • work night shifts
  • have a history of unstable mood disorder or unstable anxiety disorder
  • use a hearing aid
  • have a cochlear implant
Show all 11Show fewer
  • abuse alcohol or other drugs
  • 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).
  • have had eye surgery within the previous three months or ear surgery within the previous six months
  • have active ear infections or a perforated tympanic membrane
  • have participated in another clinical trial within the last 30 days or are currently enrolled in another clinical trial

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Miami Miller School of Medicine

    Miami, Florida, 33136

Other trials in United States

About this study

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.

Read the 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).
Conditions
Headache
Being tested
Device
Keywords
vestibular migraines, dizziness, migraine headache
Medical subject headings
Headache, Dizziness, Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DeviceDevice

    Also called Caloric stimulation

    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.
Study groups in NCT02866084
Study groupRoleWhat they receive
DeviceExperimentalNeuromodulation
Receives: Device: Device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dizziness Handicap Inventory

    Questionnaire of dizziness symptoms

    Measured: Until study completion up to 12 months

  2. Headache Impact Test

    Headache questionnaire

    Measured: Until study completion up to 12 months

  3. Activities Balance Confidence Interval

    Dizziness questionnaire

    Measured: Until study completion up to 12 months

  4. OVRT Testing

    Oculomotor, vestibular, and reaction time tests

    Measured: Until study completion up to 12 months

Secondary outcomes (2)

  1. Epworth Sleepiness Scale

    Sleepiness questionnaire

    Measured: Until study completion up to 12 months

  2. T2 Mood Tracker app

    App to assess mood and anxiety

    Measured: Until study completion up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2016 (estimated)
  2. Study start28 Sep 2016
  3. Primary completionMay 2019 (estimated)
  4. Study completionMay 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02866084
Sponsor's protocol ID
20160566
Status last verified
May 2019
First submitted
5 Aug 2016
Last updated
29 May 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Saper JR, Dodick DW, Silberstein SD, McCarville S, Sun M, Goadsby PJ; ONSTIM Investigators. Occipital nerve stimulation for the treatment of intractable chronic migraine headache: ONSTIM feasibility study. Cephalalgia. 2011 Feb;31(3):271-85. doi: 10.1177/0333102410381142. Epub 2010 Sep 22.

    PubMed 20861241

  • Tedeschi G, Russo A, Conte F, Laura M, Tessitore A. Vestibular migraine pathophysiology: insights from structural and functional neuroimaging. Neurol Sci. 2015 May;36 Suppl 1:37-40. doi: 10.1007/s10072-015-2161-x.

    PubMed 26017509

Questions about this trial

What is this clinical trial studying?

A study testing Device in people with Headache, run by University of Miami at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 29 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dizziness Handicap Inventory (time frame: Until study completion up to 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02866084, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2019.

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