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| Name | Class |
|---|---|
| Scion NeuroStim | INDUSTRY |
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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.
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
Secondary Efficacy Endpoints for the Pilot Study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device | Experimental | Neuromodulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Device | Device | The following parameters will be set for active treatments using the CVS Device:
|
| Measure | Description | Time Frame |
|---|---|---|
| Dizziness Handicap Inventory | Questionnaire of dizziness symptoms | Until study completion up to 12 months |
| Headache Impact Test | Headache questionnaire | Until study completion up to 12 months |
| Activities Balance Confidence Interval | Dizziness questionnaire | Until study completion up to 12 months |
| OVRT Testing | Oculomotor, vestibular, and reaction time tests | Until study completion up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Epworth Sleepiness Scale | Sleepiness questionnaire | Until study completion up to 12 months |
| T2 Mood Tracker app | App to assess mood and anxiety |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Miller School of Medicine | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20861241 | Background | 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. | |
| 26017509 | Background |
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| ID | Term |
|---|---|
| D006261 | Headache |
| D004244 | Dizziness |
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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|
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| Until study completion up to 12 months |
| 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. |
| D012678 | Sensation Disorders |
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |