Neuromodulation Treatment of Vestibular Migraines

Not Applicable

Withdrawn

• Conditions: Headache
• Interventions: Device: Device

• Registration Number: NCT02866084
• Lead Sponsor: 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.

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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-08-05
• Study First Submitted QC: 2016-08-09
• Study First Posted: 2016-08-15
• Study Start: 2016-09-28
• Status Verified: 2019-05
• Primary Completion: 2019-05
• Study Completion: 2019-05
• Last Update Submitted: 2019-05-24
• Last Update Posted: 2019-05-29

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Device	Device	Neuromodulation

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Epworth Sleepiness Scale	Until study completion up to 12 months	Sleepiness questionnaire
T2 Mood Tracker app	Until study completion up to 12 months	App to assess mood and anxiety

Trial Locations

Locations (1)

University of Miami Miller School of Medicine; 🇺🇸 Miami, Florida, United States