NCT02866084

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 15, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

September 28, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

May 29, 2019

Status Verified

May 1, 2019

Enrollment Period

2.6 years

First QC Date

August 5, 2016

Last Update Submit

May 24, 2019

Conditions

Headache

Keywords

vestibular migrainesdizzinessmigraine headache

Outcome Measures

Primary Outcomes (4)

  • Dizziness Handicap Inventory

    Questionnaire of dizziness symptoms

    Until study completion up to 12 months

  • Headache Impact Test

    Headache questionnaire

    Until study completion up to 12 months

  • Activities Balance Confidence Interval

    Dizziness questionnaire

    Until study completion up to 12 months

  • OVRT Testing

    Oculomotor, vestibular, and reaction time tests

    Until study completion up to 12 months

Secondary Outcomes (2)

  • Epworth Sleepiness Scale

    Until study completion up to 12 months

  • T2 Mood Tracker app

    Until study completion up to 12 months

Study Arms (1)

Device

EXPERIMENTAL

Neuromodulation

Device: Device

Interventions

DeviceDEVICE

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.

Also known as: Caloric stimulation
Device

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

Related Publications (2)

  • 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.

    PMID: 20861241BACKGROUND

  • 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.

    PMID: 26017509BACKGROUND

MeSH Terms

Conditions

HeadacheDizzinessMigraine Disorders

Interventions

Equipment and Supplies

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSensation DisordersHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 5, 2016

First Posted

August 15, 2016

Study Start

September 28, 2016

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

May 29, 2019

Record last verified: 2019-05

Locations

US(1)