Response to Combined Trigeminal and Occipital Nerve Stimulation for the Preventive Treatment in Chronic Cluster Headache
Recruiting
N/A
Interventional Study
Chronic Cluster Headache
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Device Feasibility
- Participants needed
- 10 (estimated)
- Sponsor
- Salvia BioElectronics · Industry
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About This Trial
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 a…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Able and willing to provide informed consent
2. 18 years of age or older
3. Documented Primary Chronic Cluster Headache, for at least 1 year as per ICHD-3 criteria
Exclusion Criteria:
1. Any other chronic primary or secondary headache disorder, unless they can clearly diffe…
Contacts