First Evaluation of a Craniofacial Peripheral Nerve Stimulation System in Chronic Migraine

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate the safe use of the novel cranio-facial peripheral nerve stimulator (PNS) System in subjects with chronic migraine. This is a single-centre, open label, prospective, early feasibility study to collect initial clinical data on the PNS System for the treatment of chronic migraine.

Official Title
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First Evaluation of a Craniofacial Peripheral Nerve Stimulation System in Chronic Migraine, an Early Feasibility Study

Conditions
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Chronic Migraine

Intervention / Treatment
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* Device: PRIMUS


Participation Criteria
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Eligibility Criteria
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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, …) Metal implants in the skull (e.g. skull plates, seeds) nearby the implant. Have a pacemaker of implantable cardioverter defibrillator (ICD) Current Opioid Use, defined as one or more opioids on more than 4 days/month for 3 consecutive months. Use of botulinum toxin injections in the past 3 months. Women of childbearing age who are pregnant, nursing or not using contraception

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 84 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRIMUS<br>PRIMUS PNS System | Device: PRIMUS<br>* Peripheral Nerve Stimulator System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Evaluation | The primary safety assessment is the incidence of serious procedure- and/or device-related adverse events in all subjects at 30 days and at the end of the study. All adverse clinical events will be collected, coded, and reported, for the duration of the study according to the definitions of ISO 14155:2020. | 30 days | 
| Safety Evaluation | The primary safety assessment is the incidence of serious procedure- and/or device-related adverse events in all subjects at 30 days and at the end of the study. All adverse clinical events will be collected, coded, and reported, for the duration of the study according to the definitions of ISO 14155:2020. | 12 months |