Neuromodulation Treatment of Vestibular Migraines

Headache Clinical Trial

Official title:

Neuromodulation Treatment of Vestibular Migraines

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02866084
• Other study ID #: 20160566
• Status: Withdrawn
• Phase: N/A
• Start date: September 28, 2016
• Est. completion date: May 2019

Study information

• Verified date: May 2019
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Headache
• Migraine Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	University of Miami Miller School of Medicine	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Scion NeuroStim

Country where clinical trial is conducted

United States, 

References & 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dizziness Handicap Inventory	Questionnaire of dizziness symptoms	Until study completion up to 12 months
Primary	Headache Impact Test	Headache questionnaire	Until study completion up to 12 months
Primary	Activities Balance Confidence Interval	Dizziness questionnaire	Until study completion up to 12 months
Primary	OVRT Testing	Oculomotor, vestibular, and reaction time tests	Until study completion up to 12 months
Secondary	Epworth Sleepiness Scale	Sleepiness questionnaire	Until study completion up to 12 months
Secondary	T2 Mood Tracker app	App to assess mood and anxiety	Until study completion up to 12 months