An interventional study of The Salvia PRIMUS implantable neurostimulator System in Chronic Cluster Headache, sponsored by Salvia BioElectronics. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-16.
Sponsored by Salvia BioElectronics · Not applicable, Interventional, and Device feasibility
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.
During a Cluster Headache attack, the brain area called the hypothalamus may not do its usual job of blocking pain signals, which can make the pain worse. Stimulating the occipital nerves (at the back of the head) may help return brain activity in certain areas-like the hypothalamus, midbrain, and lower brainstem-back to normal. This could help reduce the brain's sensitivity to pain over time.
Stimulating another nerve group, called the V1 branch of the Trigeminal nerves (around the forehead and eye), can also help by interrupting pain signals and possibly stopping an attack or making it less severe and less frequent.
When both nerve areas-the Trigeminal and Occipital nerves-are stimulated together, it may have a stronger effect on reducing pain and how often headaches happen. Some early reports in a few patients have shown promising results with this combined treatment.
The PRIMUS system is a small device that can be implanted under the skin. It was designed to target both the Trigeminal and Occipital nerves at the same time, with a focus on treating severe head and face pain. It may offer relief for people with chronic cluster headaches who haven't been helped by medication.
123 studies on the registry are indexed under Cluster Headache; 26 are open to participants now.
This study's planned enrollment of 10 is below the median of 42 across 90 interventional studies indexed under Cluster Headache.
Browse Cluster Headache studies →Salvia BioElectronics is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: The Salvia PRIMUS implantable neurostimulator System
The Salvia PRIMUS implantable neurostimulator System is designed to provide subcutaneous neurostimulation to the V1 branches of the Trigeminal nerves (supra-orbital and supra-trochlear nerves) and the branches of the Greater Occipital Nerves. It is intended to modulate headaches' neural networks by utilizing mild electrical pulses. There are 2 stimulation waveforms options: the Salvia burst waveform providing paresthesia-free stimulation and Tonic waveform, providing paresthesia-provoking stimulation. The PRIMUS System comprises a 25 cm (forehead) and a 17cm (back of the head) subcutaneous implant, a MySalvia device, a programmer, and surgical tooling.
Safety Assessment
The primary safety assessment is the incidence of serious procedure and/or device-related adverse events in all subjects at the 12 week visit and at the end of the study. All adverse clinical events will be collected, coded and reported, throughout the duration of the study according to the definitions of ISO 14155:2020. Device and procedure-related adverse events will be distinguished from stimulation-related adverse events. All device deficiencies, as defined by ISO 14155:2020, will be documented and reported throughout the duration of the study.
Time frame: 12 weeks
Plan to share: Undecided
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