Neuromodulation Treatment of Vestibular Migraines
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02866084|
Recruitment Status : Active, not recruiting
First Posted : August 15, 2016
Last Update Posted : July 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Headache||Device: Device||Not Applicable|
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
- Reduction in the frequency and severity of migraine headaches (self reported in pain diary)
- 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
- Improvement in sleep quality and/or quantity as assessed by the Epworth Sleep Scale.
- Improvement in quality of life as assessed by the HIT-6 survey.
- Improvement in mood/anxiety as assessed with the T2 Mood Tracker app (National Center for Telehealth & Technology).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Neuromodulation Treatment of Vestibular Migraines|
|Actual Study Start Date :||September 28, 2016|
|Estimated Primary Completion Date :||February 2019|
|Estimated Study Completion Date :||February 2019|
The following parameters will be set for active treatments using the CVS Device:
Other Name: Caloric stimulation
- Dizziness Handicap Inventory [ Time Frame: Until study completion up to 12 months ]Questionnaire of dizziness symptoms
- Headache Impact Test [ Time Frame: Until study completion up to 12 months ]Headache questionnaire
- Activities Balance Confidence Interval [ Time Frame: Until study completion up to 12 months ]Dizziness questionnaire
- OVRT Testing [ Time Frame: Until study completion up to 12 months ]Oculomotor, vestibular, and reaction time tests
- Epworth Sleepiness Scale [ Time Frame: Until study completion up to 12 months ]Sleepiness questionnaire
- T2 Mood Tracker app [ Time Frame: Until study completion up to 12 months ]App to assess mood and anxiety
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02866084
|United States, Florida|
|University of Miami Miller School of Medicine|
|Miami, Florida, United States, 33136|