Clinical trial NCT02866084: Neuromodulation Treatment of Vestibular Migraines
Official title: Neuromodulation Treatment of Vestibular Migraines
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Headache
Keywords: vestibular migraines
dizziness
migraine headache
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Scion NeuroStim
First posted: 2016-08-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Dizziness Handicap Inventory
timeFrame: Until study completion up to 12 months
measure: Headache Impact Test
timeFrame: Until study completion up to 12 months
measure: Activities Balance Confidence Interval
timeFrame: Until study completion up to 12 months
measure: OVRT Testing
timeFrame: Until study completion up to 12 months
Secondary outcomes:
measure: Epworth Sleepiness Scale
timeFrame: Until study completion up to 12 months
measure: T2 Mood Tracker app
timeFrame: Until study completion up to 12 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
Study officials:
References:
citation: 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.
citation: 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.