Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07113470

Response to Combined Trigeminal and Occipital Nerve Stimulation for the Preventive Treatment in Chronic Cluster Headache

Led by Salvia BioElectronics · Updated on 2026-03-25

10

Participants Needed

1

Research Sites

141 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a limited open-label study being performed at two centers in the Netherlands. All participants will receive the same treatment, and both the patients and doctors will know what that treatment is. The goal is to see how safe and effective the PRIMUS system is for preventing Chronic Cluster Headaches (CCH) in people who haven't responded well to the drug verapamil. The study will also look at the patients' experience using the system.

CONDITIONS

Official Title

Response to Combined Trigeminal and Occipital Nerve Stimulation for the Preventive Treatment in Chronic Cluster Headache

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Able and willing to provide informed consent
  • 18 years of age or older
  • Documented Primary Chronic Cluster Headache for at least 1 year according to ICHD-3 criteria
Not Eligible

You will not qualify if you...

  • Presence of any other chronic primary or secondary headache disorder unless clearly distinguishable from cluster headache attacks
  • Diagnosis of Secondary Cluster Headache

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

LUMC Leids Universitair Medisch Centrum

Leiden, Netherlands

Actively Recruiting

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Research Team

R

Rolf Fronczek, Dr.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DEVICE_FEASIBILITY

Number of Arms

1

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