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

NANot yet recruitingINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

December 1, 2025

Primary Completion Date

October 1, 2026

Study Completion Date

October 1, 2028

Conditions
Chronic Cluster Headache
Interventions
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.

Sponsors
All Listed Sponsors
lead

Salvia BioElectronics

INDUSTRY

NCT07113470 - Response to Combined Trigeminal and Occipital Nerve Stimulation for the Preventive Treatment in Chronic Cluster Headache | Biotech Hunter | Biotech Hunter