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

Not Applicable

Active, not recruiting

• Conditions: Chronic Migraine
• Interventions: Device: PRIMUS

• Registration Number: NCT05858801
• Lead Sponsor: Salvia BioElectronics

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-05
• Study First Submitted QC: 2023-05-05
• Study Start: 2023-05-09
• Study First Posted: 2023-05-15
• Primary Completion: 2023-12-09
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-13
• Last Update Posted: 2024-05-16
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PRIMUS	PRIMUS	PRIMUS system

Primary Outcome Measures

Name	Time	Method
Safety Evaluation	12 months	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.

Trial Locations

Locations (1)

AZ Delta; 🇧🇪 Roeselare, Belgium