Combined trigeminal (V1) and occipital nerve stimulation to prevent chronic cluster headache

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a small open‑label study performed at centers in the Netherlands in which all participants receive the same implanted PRIMUS neurostimulator and both patients and clinicians know the treatment. The device is designed to stimulate the V1 branch of the trigeminal nerve and the occipital nerves simultaneously to interrupt pain signaling and modify pain‑processing regions such as the hypothalamus and brainstem. The trial focuses on adults with primary chronic cluster headache of at least one year who did not respond adequately to verapamil. Safety, impact on attack frequency and severity, and patient experience with the system will be collected during follow‑up.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Able and willing to provide informed consent
2. 18 years of age or older
3. Documented Primary Chronic Cluster Headache, for at least 1 year as per ICHD-3 criteria

Exclusion Criteria:

1. 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
2. Secondary Cluster Headache

Where it's running

• LUMC Leids Universitair Medisch Centrum
  Leiden, Netherlands Recruiting

Study contacts

• Study coordinator: Rolf Fronczek, Dr.
• Email: hoofdpijnonderzoek@lumc.nl
• Phone: +31715262197

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.