Response to Combined Trigeminal and Occipital Nerve Stimulation for the Preventive Treatment in Chronic Cluster Headache (RESPONSE-II)

Salvia BioElectronics

Status: Not yet enrolling

Conditions: Chronic Cluster Headache

Treatments: Device: The Salvia PRIMUS implantable neurostimulator System

Study type: Interventional

Funder types: Industry

Identifiers

NCT07113470

NL-010395 (Other Identifier)

SCI-04-CCH

Details and patient eligibility

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.

Full description

During a Cluster Headache attack, the brain area called the hypothalamus may not do its usual job of blocking pain signals, which can make the pain worse. Stimulating the occipital nerves (at the back of the head) may help return brain activity in certain areas-like the hypothalamus, midbrain, and lower brainstem-back to normal. This could help reduce the brain's sensitivity to pain over time.

Stimulating another nerve group, called the V1 branch of the Trigeminal nerves (around the forehead and eye), can also help by interrupting pain signals and possibly stopping an attack or making it less severe and less frequent.

When both nerve areas-the Trigeminal and Occipital nerves-are stimulated together, it may have a stronger effect on reducing pain and how often headaches happen. Some early reports in a few patients have shown promising results with this combined treatment.

The PRIMUS system is a small device that can be implanted under the skin. It was designed to target both the Trigeminal and Occipital nerves at the same time, with a focus on treating severe head and face pain. It may offer relief for people with chronic cluster headaches who haven't been helped by medication.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

10 participants in 1 patient group

MySalvia Therapy

Experimental group

Treatment:

Device: The Salvia PRIMUS implantable neurostimulator System