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

NCT05858801 | Active Not Recruiting

• 1 other identifier: SCI-02-CM
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Migraine

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

PRIMUS

EXPERIMENTAL

PRIMUS system

Device: PRIMUS

Interventions

PRIMUS DEVICE

PRIMUS system

PRIMUS

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Salvia BioElectronics: lead

Study Sites (1)

AZ Delta

Roeselare, Belgium

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: May 15, 2023
• Study Start: May 9, 2023
• Primary Completion: December 9, 2023
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)