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

Chronic Migraine Clinical Trial

— RELIEF  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05858801
• Other study ID #: SCI-02-CM
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 9, 2023
• Est. completion date: January 31, 2026

Study information

• Verified date: May 2024
• Source: Salvia BioElectronics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 7
• Est. completion date: January 31, 2026
• Est. primary completion date: December 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 84 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Migraine
• Migraine Disorders

Intervention

Device:
• PRIMUS
PRIMUS system

Locations

Country	Name	City	State
Belgium	AZ Delta	Roeselare

Sponsors (1)

Lead Sponsor	Collaborator
Salvia BioElectronics

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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