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.
NCT: NCT07677137 · RECRUITING
Brief Summary
The purpose of this clinical trial is to evaluate the safety and effectiveness of the Occipital Nerve Stimulation System (ONSS) in treating chronic cluster headache in adults. The study aims to answer the following questions: * What adverse events or medical complications occur following ONSS implantation and stimulation? * Does treatment with the ONSS reduce the frequency of cluster headache attacks compared with baseline? Participant Involvement Participants will: * Undergo implantation of the ONSS device. * Use the ONSS for a 48-week treatment period. * Attend scheduled clinic visits for follow-up assessments and device evaluations. * Maintain a diary documenting cluster headache attacks and use of rescue medications. * Complete study-related assessments throughout the study period.
Frequently Asked Questions
What is 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.?
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. is a clinical trial registered under NCT07677137. Current status: RECRUITING.
What is the status of NCT07677137?
The current status of NCT07677137 (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.) is: RECRUITING.
When did 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. start?
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. started on 2026-05-18.
Official Source
View on ClinicalTrials.gov →Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.