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Study identifier: NCT07677137 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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.

Condition: Chronic Cluster Headache  ·  Sponsor: Man and Science, SA

PhaseNA
Planned participants10
Who can joinAll sexes, 22 Years to 70 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Christelle Nguepi  ·  +34 613 581 071  ·  c.nguepi@manandscience.com

Always discuss trial participation with your own doctor first.

Locations (1)

VITAZSint-Niklaas, BelgiumRecruiting

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Source record: clinicaltrials.gov/study/NCT07677137