The RECLAIM Study.

Randomized, Double-blind, Controlled Trial to Investigate Combined Occipital and Supra-orbital Neuromodulation in Resistant Migraine. The RECLAIM Study.

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.

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 local corticosteroid injections in the occipital or supra-orbital region in the past 3 months prior to enrollment.
• Not pregnant, nursing or not using contraception