REsponse to Combined SONS and ONS in Chronic Cluster headachE (NCT05868044) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
REsponse to Combined SONS and ONS in Chronic Cluster headachE
Australia5 participantsStarted 2023-05-02
Plain-language summary
The purpose of this study is to demonstrate the safe use of the PRIMUS System in subjects with chronic cluster headache. This is a single-centre, open label, prospective, first in human study to collect initial clinical data on the PRIMUS system for the treatment of chronic cluster headache.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Main Inclusion Criteria:
* Able and willing to provide informed consent
* Documented chronic cluster headache for at least 1 year as per ICHD-3 criteria
* Attack frequency of ≥ 4 attacks per week for ≥ 4 weeks before enrolment
* Documented failure of verapamil (failure meaning ineffective, provoked unacceptable side-effects or contra-indicated)
* Stable on preventive treatment for at least two weeks prior to enrolment.
* Agree to refrain from starting new prophylactic cluster headache medication or other preventive treatments, from 4 weeks before entering the baseline period throughout the duration of the study
* MRI available (not older than 4 years prior to study enrolment) or willing to undergo an MRI to exclude structural lesions potentially causing headache
* Able and willing to complete a headache Diary
Main Exclusion Criteria:
* Any other chronic primary or secondary headache disorder, unless they can clearly differentiate them from cluster headache attacks based on the quality and associated symptoms
* Concomitant neuromodulation, except tVNS
* Previous failure to any implantable neuromodulation device for neurovascular headache
* Have an existing Active Implantable Medical Device nearby the implant location (e.g. DBS, cochlear implant, …)
* Metal implants in the skull (e.g. skull plates, seeds) nearby the implant
* Have a pacemaker or implantable cardioverter defibrillator (ICD)
* Suboccipital infiltrations with steroids and/or local anaesthetics or use of oral st…