Study of Occipital Nerve Stimulation for Drug Refractory Migraine

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and effectiveness of an implantable device to treat migraine. There are a significant number of patients who have drug refractory migraine and alternative therapies are needed.

Official Title
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A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of Occipital Nerve Stimulation for Drug Refractory Migraine

Conditions
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Migraine

Intervention / Treatment
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* Device: Precision


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be diagnosed with multiple migraines per month of moderate to severe intensity; Be refractory to medication; Be an appropriate candidate for the surgical procedures required fo this study; Be willing and able to comply with all study related procedures; Be capable of reading and understanding patient information materials and giving written informed consent. Exclusion Criteria: Have onset of headache after age 50; Are current substance abusers (including alcohol and illicit drugs); Have a significant psychiatric disorder; Have previously been treated with occipital nerve stimulation (either temporary trial or permanent implant); Have had nerve stimulation for pain relief. Have had an injection of botulinum toxin in the head or neck within 6 months prior to enrollment; Have previously undergone destructive ganglionectomy affecting C2/C3 occipital and/or trigeminal distribution or have an occipital blockade or radiofrequency procedure currently in effect. Have a condition currently requiring or likely to require the use of MRI or diathermy; Have an active implantable device; Are pregnant or lactating or planning to become pregnant in the next 14 months; Have participated in any drug or device trial in the last 4 weeks or plant to participate in any other study during the next 14 months.

Ages Eligible for Study
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Minimum Age: 18 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Stimulation on from activation to 12 weeks post-activation. Stimulation off from 12 weeks post-activation to 16 weeks post-activation. Stimulation on from 16 weeks post-activation to end of study. | Device: Precision<br>* Implantable Neurostimulator<br>|
| Sham Comparator: 2<br>Sham Stimulation from activation of device to 12 weeks post-activation. Stimulation on from 12 weeks post-activation on. | Device: Precision<br>* Implantable Neurostimulator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Hours of Headache |  | 12 weeks | 
| Number of Days With 4 or More Hours of Headache |  | 12 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Headache, Migraine, Refractory, Chronic, Pain