Neuromodulation Treatment of Vestibular Migraines

NCT ID: NCT02866084

Last Updated: 2019-05-29

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-28
• Study Completion Date: 2019-05-31

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).

Conditions

Headache

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Device

Neuromodulation

Group Type: EXPERIMENTAL

Device

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Caloric stimulation

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Scion NeuroStim

INDUSTRY

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Michael E. Hoffer

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Miami Miller School of Medicine

Miami, Florida, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 20861241 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26017509 (View on PubMed)

Other Identifiers

20160566

Identifier Type: -

Identifier Source: org_study_id