Plain-English translation of NCT07113470 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.
This trial is testing the PRIMUS system, a small implanted device designed to stimulate two different nerve groups in your head at the same time. By targeting the trigeminal nerves (around your forehead and eyes) and the occipital nerves (at the back of your head), the device aims to interrupt pain signals and reduce how often and how severely cluster headaches occur. Early results in a small number of patients have shown promise, and this study will test whether this combination approach works for people with chronic cluster headaches who haven't found adequate relief through medications.
Chronic cluster headaches are severe and can be disabling, especially for people whose pain doesn't respond well to standard medications. This trial exists because researchers believe that stimulating these two nerve groups together may be more effective than treating them separately, offering hope to patients who have limited options.
You likely qualify if…
You likely don't qualify if…
If you join this trial, you will undergo a procedure to have the PRIMUS device implanted under your skin. After implantation, the device will deliver gentle electrical stimulation to help prevent your cluster headaches. You will need to attend follow-up visits so the research team can monitor how well the treatment is working and adjust the device settings if needed. The trial is small (enrolling only 10 participants total) and is still recruiting, so you would be among the first to try this combined nerve stimulation approach.
AI-generated summary from trial data · Oct 7, 2026 · Not medical advice
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