First Evaluation of a Craniofacial Peripheral Nerve Stimulation System in Chronic Migraine (NCT05858801) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
First Evaluation of a Craniofacial Peripheral Nerve Stimulation System in Chronic Migraine
Belgium7 participantsStarted 2023-05-09
Plain-language summary
The purpose of this study is to demonstrate the safe use of the PRIMUS system in subjects with chronic migraine. This is a single-center, open label, prospective, early feasibility study to collect initial clinical data on the PRIMUS system for the treatment of chronic migraine.
Who can participate
Age range18 Years – 84 Years
SexALL
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Main Inclusion Criteria:
* Able and willing to provide informed consent
* Age ≥ 18 years and ≤ 84 years at time of consent
* Documented Chronic Migraine, defined as at least eight migraine days/month, for at least 1 year.
* Developed migraine before the age of 50
* Documented failure of 3 or more other preventive therapies (failure meaning ineffective, provoked unacceptable side-effects or contra-indicated) from which at least 1 of the following 2: CGRP mAbs or Onabotulinumtoxin A
* Have at least 1 headache free day per month
* Stable on preventive migraine drugs and alternative treatment for at least three months prior to enrollment.
* Agree to refrain from starting new preventive migraine drugs or other preventive alternative migraine 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 enrollment) or willing to undergo an MRI to exclude structural lesions potentially causing headache
* Able and willing to complete a daily headache eDiary
Main Exclusion Criteria:
* Any other chronic primary or secondary headache disorder, unless they can clearly differentiate them from migraine attacks, based on the quality of pain and associated symptoms.
* Concomitant neuromodulation
* Previous failure to an implantable neuromodulation device for neurovascular headache
* Have an existing Active Implantable Medical Device nearby the implant location (e.g. DBS, cochlear implant, …)
* Meta…