First Evaluation of a Craniofacial Nerve Stimulation System in Chronic Migraine

The purpose of this study is to demonstrate the safe use of the PRIMUS system in subjects with chronic migraine. This is a single-center, open label, prospective, early feasibility study to collect initial clinical data on the PRIMUS system for the treatment of chronic migraine.

Main Inclusion Criteria: * Able and willing to provide informed consent * Age ≥ 18 years and ≤ 84 years at time of consent * Documented Chronic Migraine, defined as at least eight migraine days/month, for at least 1 year. * Developed migraine before the age of 50 * Documented failure of 3 or more other preventive therapies (failure meaning ineffective, provoked unacceptable side-effects or contra-indicated) from which at least 1 of the following 2: CGRP mAbs or Onabotulinumtoxin A * Have at least 1 headache free day per month * Stable on preventive migraine drugs and alternative treatment for at least three months prior to enrollment. * Agree to refrain from starting new preventive migraine drugs or other preventive alternative migraine treatments, from 4 weeks before entering the baseline period throughout the duration of the study. * MRI available (not older than 4 years prior to study enrollment) or willing to undergo an MRI to exclude structural lesions potentially causing headache * Able and willing to complete a daily headache eDiary Main Exclusion Criteria: * Any other chronic primary or secondary headache disorder, unless they can clearly differentiate them from migraine attacks, based on the quality of pain and associated symptoms. * Concomitant neuromodulation * Previous failure to an implantable neuromodulation device for neurovascular headache * Have an existing Active Implantable Medical Device nearby the implant location (e.g. DBS, cochlear implant, …) * Metal implants in the skull (e.g. skull plates, seeds) nearby the implant. * Have a pacemaker of implantable cardioverter defibrillator (ICD) * Current Opioid Use, defined as one or more opioids on more than 4 days/month for 3 consecutive months. * Use of botulinum toxin injections in the past 3 months. * Women of childbearing age who are pregnant, nursing or not using contraception