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

Recruiting now · Not applicable

Conditions studied: Chronic Cluster Headache

In brief

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.

Key facts

Study ID

NCT07113470

Run by

Salvia BioElectronics

People needed

10

Starts

2026-04-13

Expected to finish

2028-12-01

Last updated by the study team

2026-07-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• LUMC Leids Universitair Medisch Centrum — Leiden, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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