Treatment for Migraines With an Implantable Device

Precision Implantable Stimulator for Migraine (PRISM) Study- Occipital Nerve Stimulation (ONS) for Migraine

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

Key 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.

Key Exclusion Criteria:

• 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.