Response to Combined Trigeminal and Occipital Nerve Stimulation for the Preventive Treatment in Chronic Cluster Headache

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSalvia BioElectronics

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

Treatment groups

10 Participants
are divided into 1 treatment group

Sponsors and collaborators