Treatment for Migraines With an Implantable Device

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 for 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:

- Have onset of migraine after age 50;

- Have a significant psychiatric disorder;

- Have previously been treated with occipital nerve stimulation;

- 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 radio frequency procedure
currently in effect;

- Have a condition currently requiring or likely to require the use of MRI or diathermy;

- Have an active implantable device;

- Have participated in any drug or device trial in the last 4 weeks or plan to
participate in any other study.