Overview

The purpose of this study is to evaluate the safety and performance, including clinical benefit, of the PRIMUS System for the treatment of Resistant Migraine.

Eligibility

Inclusion Criteria:

• Diagnosis of migraine as defined by the ICHD-3 Classification (with or without aura) with a history of chronic or high-frequency episodic migraine for at least 1 year prior to screening
• Failure of 3 or more preventive pharmacological therapies
• Stable on preventive migraine treatments
• Psychologically stable

Exclusion Criteria:

• Concomitant invasive or non-invasive neuromodulation
• Previous exposure to an implantable neuromodulation device for headache
• Have an existing active implantable medical device nearby the implant location (e.g. DBS, cochlear implant)
• Use of onabotulinum toxin A injections for the treatment of migraine in the past 3 months.
• Use of steroid infiltrations or IV administration in the past 3 months.
• Not pregnant, nursing or not using contraception