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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Safety Assessment — 12 weeks
  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.

Trial sites (1)

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