Response to Combined Trigeminal and Occipital Nerve Stimulation for the Preventive Treatment in Chronic Cluster Headache: The RESPONSE-II Study
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Able and willing to provide informed consent
• 18 years of age or older
• Documented Primary Chronic Cluster Headache, for at least 1 year as per ICHD-3 criteria
Locations
Other Locations
Netherlands
LUMC Leids Universitair Medisch Centrum
RECRUITING
Leiden
Contact Information
Primary
Rolf Fronczek, Dr.
hoofdpijnonderzoek@lumc.nl
+31715262197
Time Frame
Start Date: 2026-03-17
Estimated Completion Date: 2028-12-01
Participants
Target number of participants: 10
Treatments
Experimental: MySalvia Therapy
Related Therapeutic Areas
Sponsors
Leads: Salvia BioElectronics