Bilateral Occipital Nerve Field Stimulation for the Treatment of dtCCH

Exclusion Criteria

• •1. Other significant neurological, psychiatric, or disabling diseases which in the opinion of the investigator may interfere with the study.
• •2. History of epilepsy, current treatment of epilepsy
• •3. Documented history of cerebrovascular accident (CVA)
• •4. Subjects suffering from a substance use disorder, as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria. Recreational use of cannabis is allowed.
• •5. Subjects at high risk of suicide/suicidal ideation in the past one year assessed with the C-SSRS
• •6. Having another active implanted device such as a cardiac pacemaker, a spinal cord, peripheral nerve, sphenopalatine ganglion, or deep brain hypothalamic stimulator, and/or a drug delivery pump, etc.
• •7. Cranial botulinum toxin injections in the past 3 months before enrolment. Administration of the following treatments in the last month before enrolment: monoclonal antibodies blocking calcitonin gene-related peptide transmission, suboccipital infiltrations with steroids and/or local anaesthetics, oral steroids, radiofrequency procedure or infiltrations of the sphenopalatine ganglion, opioids WHO 3.
• •8. Medication overuse headache (ICHD 3 8.2)
• •9. Inability to fill out an electronic diary.
• •10. Previous surgery or trauma involving the cervical spine or the occipital bone
• •11. Coagulopathy or required anticoagulant medications that cannot be safely discontinued in the perioperative period.
• •12. Concurrent participation in another clinical study
• •13. Planned pregnancy, pregnancy, or breastfeeding.