A Pivotal Clinical Study to Evaluate the MySalvia System for the Treatment of Resistant Migraine

Purpose

The purpose of this pivotal clinical study is to evaluate the safety and effectiveness of the MySalvia System, a minimally invasive implantable neuromodulation therapy, for the preventive treatment of adults with resistant migraine.

Conditions

  • Resistant Migraine
  • Chronic Migraine Headache
  • Headache (Migraine)
  • Headache, Cluster

Eligibility

Eligible Ages
Between 22 Years and 84 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

Meets resistant migraine criteria: 1. Documented diagnosis of 1.1 migraine without aura and/or 1.2 migraine with aura and/or 1.3 chronic migraine according to ICHD-3 2. Headache requiring two of the following: - Leads to considerable impairment in personal, educational and/or occupational areas of functioning (MIDAS rating of severe or very severe) - Concomitant continuous or near continuous headache between migraine attacks - Eight or more monthly migraine days 3. Lack of 50% reduction in monthly migraine days and/or intolerable side effects and/or absolute contraindication to three or more (but not all) classes of at least one evidence-based medication. The classes must include Onabotulinumtoxin A and CGRP mabs/antagonists. 4. Not better accounted for by another ICHD-3 diagnosis 4. History of migraine onset before 50 years of age 5. Stable dose of all preventive migraine medication(s) and alternative therapies for at least three months before the start of the eligibility phase

Exclusion Criteria

  • Presence of another chronic primary or secondary headache disorder, unless the participant can reliably differentiate these headaches attacks from migraine attacks, based on the pain characteristics and associated symptoms - Concurrent use of any invasive or non-invasive neuromodulation. - Previous inadequate response to an implantable neuromodulation device for headache or pain management. - Have an existing active implantable medical device nearby the implant location (e.g. DBS, cochlear implant). - Use of onabotulinum toxin A injections for the treatment of migraine in the past 3 months. Presence of an active implantable medical device (e.g. pacemaker, implantable cardiac defibrillator, neurostimulator, cochlear implant). - Presence of metal or magnet implants in the skull or cranial region (e.g. skull plates, seeds) - Pregnant, nursing or not using contraception.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Active Group
  • Device: Neurostimulator
    A neurostimulation system that consists of implantable and non-implantable components that work together to deliver mild electrical signals to targeted craniofacial nerves.
Active Comparator
Active Control Group
  • Device: Neurostimulator
    A neurostimulation system that consists of implantable and non-implantable components that work together to deliver mild electrical signals to targeted craniofacial nerves.

Recruiting Locations

Vista Clinical Research
Newnan, Georgia 30265
Contact:
Debra Helton, CCRC, MLT
770-755-6914
dhelton@vistaclinresearch.com

MedStar Health Research Institute
Olney, Maryland 20832
Contact:
Meselu Amare, Clinical Research Coordinator II
301-570-8508
Meselu.B.Amare@medstar.net

Queen City Clinical Research, PLLC
Charlotte, North Carolina 28211
Contact:
Shannon Hill, Director of Clinical Research
704-405-6150
recruitment@qccresearch.com

More Details

Status
Recruiting
Sponsor
Salvia BioElectronics

Study Contact