A Non-Invasive Neuromodulation Device for Treatment of Migraine Headache

Study Overview
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Brief Summary
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This is a randomized, blinded study designed to assess the efficacy of a portable, non-invasive neuromodulation system for the treatment of episodic migraine headaches.

Official Title
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A Non-Invasive Neuromodulation Device for Treatment of Migraine Headache

Conditions
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Migraine Headache, Episodic

Intervention / Treatment
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* Device: neuromodulation for episodic migraine headache


Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA: The patient must have been diagnosed with episodic Migraine Headache at least 6 months prior to entering into the Study, consistent with the International Headache Classification of Headache Disorders-II (ICHD-II) guidelines. The patient must have a history of at least three consecutive months of stable Migraine Headaches prior to entering the Study. The patients will not have had changes in medication usage for the three Months leading up to the Study, nor will they introduce new medications during the Study period. Patients will satisfy these criteria: On a Monthly basis, at least four, and not more than a total of fourteen (4-14), Headache Days (Pain Score between one and ten) of which between four and nine (4-14) are Migraine Headache Days The patient must not have failed on more than two classes of properly administered prophylactic pharmaceutical therapies for migraine headache. The patient may be on a single migraine prophylactic as long as the dosage has not been altered within 3 months of starting the study and the dosage must not be altered for the duration of the study. The Investigator must have confidence in the patient's ability to reliably use the Experimental Device and promptly complete the Daily Headache Diary forms. The Daily Headache Diary will be completed from the beginning of the Pre-Treatment Baseline Period through the end of the Pivotal Study. EXCLUSION CRITERIA: Individuals who: are pregnant have a history of cardiovascular disease work night shifts have been diagnosed with vestibular migraine have been diagnosed with migraine with aura have menstrual migraine exclusively have been diagnosed with post-traumatic migraine have a history of unstable mood disorder or unstable anxiety disorder use a hearing aid have a cochlear implant have chronic tinnitus have temporomandibular joint disease have been diagnosed with traumatic brain injury have been diagnosed with neurological disease other than Headaches have a diagnosed vestibular dysfunction abuse alcohol or other drugs 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). are less than 18 years old or greater than 65 years old have had eye surgery within the previous three months or ear surgery within the previous six months have active ear infections or a perforated tympanic membrane have participated in another clinical trial within the last 30 days or are currently enrolled in another clinical trial are using Botox treatments for migraines Though not excluded, patients taking anti-histamines or anti-nausea drugs will be encouraged not to take such medications within four hours prior to using the Device. The Investigator should review other medications taken by the patient with properties that mimic anti-nausea or anti-dizziness drugs as these may reduce responsiveness to stimulation. Such medications should also be avoided within four hours prior to a treatment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: active device<br>A standardized active neuromodulation waveform will be used for all active Device patients at all Study sites. The Device will be used twice daily. | Device: neuromodulation for episodic migraine headache<br> <br> |
| Placebo Comparator: placebo device<br>A standardized placebo neuromodulation waveform will be used for all placebo Device patients at all Study sites. The Device will be used twice daily. | Device: neuromodulation for episodic migraine headache<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of monthly migraine headache days | During the third Month of Device use, the average total number of Monthly Migraine Headache Days will be lower than comparable averages derived from the Pre-use Baseline Period | after 84 days of Device use | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of monthly migraine headache days (reduction by by 50% or more) | A reduction of 50% or more in monthly Migraine Headache Days during the third Month of Device use as compared with the Pre-use Baseline Period. | after 84 days of Device use | 
| Total monthly pain score | During the third Month of Device use, the average Total Monthly Headache Pain Scores will be lower than comparable averages derived from the Pre-use Baseline Period. | after 84 days of Device use | 
| Mood and cognition measures - Change in mood scores | A patient's Pre-use Baseline Period mood scores will be compared with those at the end of the Device use period. Mood scores will be assessed for: a decline, no change, or an improvement. | after 84 days of Device use | 
| Verify the absence of material dizziness | The principal safety endpoint for the Study is to verify the absence of material dizziness, with the associated risk of falls, as a consequence of using the Device. | after 84 days of Device use | 
| Mood and cognition measures - Change in cognitive speed scores | A patient's Pre-use Baseline Period cognitive speed scores will be compared with those at the end of the Device use period. Cognitive speed scores will be assessed for: a decline, no change, or an improvement. | after 84 days of Device use | 
| Mood and cognition measures - Change in memory scores | A patient's Pre-use Baseline Period memory scores will be compared with those at the end of the Device use period. Memory scores will be assessed for: a decline, no change, or an improvement. | after 84 days of Device use | 
| Use of acute medications - change in number of treated headaches | During the third month of device use, the number of abortive medications taken will be less than the number taken in the baseline month | after 84 days of device use | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neuromodulation, migraine headache