Response to Combined Trigeminal and Occipital Nerve Stimulation for the Preventive Treatment in Chronic Cluster Headache

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.

Inclusion criteria

• 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

Exclusion criteria

• 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
• Secondary Cluster Headache