Actively Recruiting
Response to Combined Trigeminal and Occipital Nerve Stimulation for the Preventive Treatment in Chronic Cluster Headache
Led by Salvia BioElectronics · Updated on 2026-03-25
10
Participants Needed
1
Research Sites
141 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Response to Combined Trigeminal and Occipital Nerve Stimulation for the Preventive Treatment in Chronic Cluster Headache
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to provide informed consent
- 18 years of age or older
- Documented Primary Chronic Cluster Headache for at least 1 year according to ICHD-3 criteria
You will not qualify if you...
- Presence of any other chronic primary or secondary headache disorder unless clearly distinguishable from cluster headache attacks
- Diagnosis of Secondary Cluster Headache
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
LUMC Leids Universitair Medisch Centrum
Leiden, Netherlands
Actively Recruiting
Research Team
R
Rolf Fronczek, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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