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

NCT ID: NCT05858801

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-09
• Study Completion Date: 2026-01-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

PRIMUS

PRIMUS system

Group Type: EXPERIMENTAL

PRIMUS

Intervention Type: DEVICE

PRIMUS system

Interventions

PRIMUS

PRIMUS system

Intervention Type: DEVICE

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 84 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Salvia BioElectronics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

AZ Delta

Roeselare, , Belgium

Countries

Belgium

Other Identifiers

SCI-02-CM

Identifier Type: -

Identifier Source: org_study_id