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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.

NCT07677137 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-08-27

No results posted yet for this study

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.

Conditions

  • Chronic Cluster Headache

Interventions

DEVICE

Occipital Nerve Stimulation System

48 weeks of daily stimualtion with ONS System

Sponsors & Collaborators

  • Man and Science, SA

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-18
Primary Completion
2027-07-31
Completion
2027-07-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07677137 on ClinicalTrials.gov