About this trial
This is a limited open-label study being performed at two centers in the Netherlands. All participants will receive the same treatment, and both the patients and doctors will know what that treatment is. The goal is to see how safe and effective the PRIMUS system is for preventing Chronic Cluster Headaches (CCH) in people who haven't responded well to the drug verapamil. The study will also look at the patients' experience using the system.
Eligibility criteria
Qualifiers
Able and willing to provide informed consent
18 years of age or older
Documented Primary Chronic Cluster Headache, for at least 1 year as per ICHD-3 criteria
Disqualifiers
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
Secondary Cluster Headache
Trial design
Treatments tested in this trial
- The Salvia PRIMUS implantable neurostimulator System