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

RecruitingNAAges 18 Years - anyAllSalvia BioElectronics
NCT07113470 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • The Salvia PRIMUS implantable neurostimulator System
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Where

1 site
LUMC Leids Universitair Medisch Centrum
Leiden, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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