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Response to Combined Trigeminal and Occipital Nerve Stimulation for the Preventive Treatment in Chronic Cluster Headache
Sponsor: Salvia BioElectronics
Summary
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.
Official title: Response to Combined Trigeminal and Occipital Nerve Stimulation for the Preventive Treatment in Chronic Cluster Headache: The RESPONSE-II Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
10
Start Date
2026-03-17
Completion Date
2028-12-01
Last Updated
2026-03-25
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
LUMC Leids Universitair Medisch Centrum
Leiden, Netherlands