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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02866084
Other study ID # 20160566
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
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
Health authority
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Status Withdrawn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

Study Design


Related Conditions & MeSH terms


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
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