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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05858801
Recruitment Status : Recruiting
First Posted : May 15, 2023
Last Update Posted : May 19, 2023
Sponsor:
Information provided by (Responsible Party):
Salvia BioElectronics

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Migraine Device: PRIMUS Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: First Evaluation of a Craniofacial Peripheral Nerve Stimulation System in Chronic Migraine, an Early Feasibility Study
Estimated Study Start Date : May 9, 2023
Estimated Primary Completion Date : October 1, 2023
Estimated Study Completion Date : January 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine

Arms and Interventions
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Arm Intervention/treatment
Experimental: PRIMUS
PRIMUS PNS System
 Device: PRIMUS
Peripheral Nerve Stimulator System


Outcome Measures
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Primary Outcome Measures :
  1. Safety Evaluation [ Time Frame: 4weeks ]

    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.


  2. Safety Evaluation [ Time Frame: 12weeks ]

    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.



Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 84 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 exposure to any implantable neuromodulation device
  • 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 or calcitonin gene-related peptide inhibitors in the past 3 months.
  • Women of childbearing age who are pregnant, nursing or not using contraception
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05858801


Contacts
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Contact: Wim Pollet, MD +32 498 57 98 98 wim.pollet@salvianeuro.com

Locations
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Belgium
AZ Delta Recruiting
Roeselare, Belgium
Contact: Bart Billet, MD       bart.billet@azdelta.be   
Sponsors and Collaborators
Salvia BioElectronics
More Information
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Responsible Party: Salvia BioElectronics
ClinicalTrials.gov Identifier: NCT05858801    
Other Study ID Numbers: SCI-02-CM
First Posted: May 15, 2023    Key Record Dates
Last Update Posted: May 19, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases