Evaluating Safety and Effectiveness of the Occipital Nerve Stimulation System for Preventing Chronic Cluster Headaches in Adults with Difficult-to-treat Symptoms Over 48 Weeks

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the Occipital Nerve Stimulation System ONSS to treat chronic cluster headache in adults who have difficult-to-treat symptoms. The study aims to identify any adverse events related to the device and to determine if it reduces the frequency of cluster headache attacks over time. Participants will undergo implantation of the ONSS device and use it daily for a 48-week treatment period. They will attend scheduled clinic visits for follow-up assessments and device evaluations throughout this time. The study includes one treatment group using the ONSS device with no placebo or comparison group. During the study, participants will keep a diary to record cluster headache attacks and use of rescue medications. They will complete various assessments and questionnaires related to their condition and device use. Researchers will monitor adverse events at 12 and 48 weeks and measure changes in attack frequency, intensity, and treatment use. The total participation lasts for the 48-week treatment period following implantation.

A First-in-human Study to Assess the Initial Safety, Tolerability, and Effectiveness of the ONSS Bilateral Occipital Nerve Field Stimulation System for the Prophylactic Treatment of Chronic Cluster Headache in Difficult-to-treat Subjects.