REsponse to Combined SONS and ONS in Chronic Cluster headachE

REsponse to Combined SuPra-orbital and Occipital Nerve Stimulation in Chronic Cluster headachE With the PRIMUS System, a First in Human Study

The purpose of this study is to demonstrate the safe use of the PRIMUS System in subjects with chronic cluster headache. This is a single-centre, open label, prospective, first in human study to collect initial clinical data on the PRIMUS system for the treatment of chronic cluster headache.

Main Inclusion Criteria:

• Able and willing to provide informed consent
• Documented chronic cluster headache for at least 1 year as per ICHD-3 criteria
• Attack frequency of ≥ 4 attacks per week for ≥ 4 weeks before enrolment
• Documented failure of verapamil (failure meaning ineffective, provoked unacceptable side-effects or contra-indicated)
• Stable on preventive treatment for at least two weeks prior to enrolment.
• Agree to refrain from starting new prophylactic cluster headache medication or other preventive 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 enrolment) or willing to undergo an MRI to exclude structural lesions potentially causing headache
• Able and willing to complete a headache Diary

Main Exclusion Criteria:

• Any other chronic primary or secondary headache disorder, unless they can clearly differentiate them from cluster headache attacks based on the quality and associated symptoms
• Concomitant neuromodulation, except tVNS
• Previous failure to any 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 or implantable cardioverter defibrillator (ICD)
• Suboccipital infiltrations with steroids and/or local anaesthetics or use of oral steroids in the past 3 months
• Use of botulinum toxin injections in the past 12 weeks
• Calcitonin gene-related peptide inhibitors started less than 12 weeks prior to enrolment
• Women of childbearing age who are pregnant, nursing or not using contraception