Combined trigeminal (V1) and occipital nerve stimulation to prevent chronic cluster headache
Response to Combined Trigeminal and Occipital Nerve Stimulation for the Preventive Treatment in Chronic Cluster Headache: The RESPONSE-II Study
NA · Salvia BioElectronics · NCT07113470
The PRIMUS implant will be tried to see if stimulating both the trigeminal (V1) and occipital nerves reduces attack frequency and severity in adults with chronic cluster headache who haven't responded to verapamil.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Salvia BioElectronics (industry) |
| Locations | 1 site (Leiden) |
| Trial ID | NCT07113470 on ClinicalTrials.gov |
What this trial studies
This is a small open‑label study performed at centers in the Netherlands in which all participants receive the same implanted PRIMUS neurostimulator and both patients and clinicians know the treatment. The device is designed to stimulate the V1 branch of the trigeminal nerve and the occipital nerves simultaneously to interrupt pain signaling and modify pain‑processing regions such as the hypothalamus and brainstem. The trial focuses on adults with primary chronic cluster headache of at least one year who did not respond adequately to verapamil. Safety, impact on attack frequency and severity, and patient experience with the system will be collected during follow‑up.
Who should consider this trial
Good fit: Adults (18+) with primary chronic cluster headache for at least one year by ICHD‑3 criteria who are willing to consent and who have not had adequate response to verapamil are the intended candidates.
Not a fit: People whose cluster headaches respond well to verapamil, or those with secondary cluster headache or other chronic headache disorders that cannot be clearly differentiated, are unlikely to benefit from this targeted neurostimulation approach.
Why it matters
Potential benefit: If successful, the PRIMUS implant could reduce how often and how severely cluster attacks occur and improve daily functioning for people with chronic cluster headache who have not benefited from verapamil.
How similar studies have performed: Small early reports and case series of combined trigeminal and occipital stimulation have shown promising results in a few patients, but robust controlled evidence is still limited.
Eligibility criteria
Show full inclusion / exclusion 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 differentiate them from cluster headache attacks based on the quality and associated symptoms 2. Secondary Cluster Headache
Where this trial is running
Leiden
- LUMC Leids Universitair Medisch Centrum — Leiden, Netherlands (RECRUITING)
Study contacts
- Study coordinator: Rolf Fronczek, Dr.
- Email: hoofdpijnonderzoek@lumc.nl
- Phone: +31715262197
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Cluster Headache