Inclusion Criteria:

• Able and willing to provide written informed consent before any study related activities are performed

• ≥22 years of age at the time of consent

• Meets resistant migraine criteria as defined by the Delphi method* :

  • 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†

  • 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

  • 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*.

  • Not better accounted for by another ICHD-3 diagnosis

• History of migraine onset before 50 years of age‡

• Stable dose of all preventive migraine medication(s) and alternative therapies for at least three months before the start of the eligibility phase

• Understands the importance of maintaining stable doses of all preventive migraine medications and agrees to refrain from initiating new preventive therapies during the randomization phase (24 weeks), unless a change is required for safety or medical necessity.

• Completed a psychological evaluation administered by a qualified clinician (e.g., licensed psychologist or psychiatrist) confirming suitability for participation in a neuromodulation study.

• Able and willing to complete a daily electronic headache diary (eDiary) for the duration of the study.

• Able and willing to comply with all the study requirements, including visit schedules visits and completion of patient-reported outcome (PRO) assessments.

Inclusion criteria to be assessed at the end of the screening phase and to be confirmed prior to the implant procedure:

• Demonstrated compliance with the eDiary on at least 26 of 28 days during the final 28- days baseline period of the eligibility phase

• Have at least 8 migraine days during the final 28-day baseline period of the eligibility phase

• Have at least four (4) days with headache intensity rated as mild or lower, as defined in Appendix A, during the final 28-day baseline period 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

• History of medication overuse headache (MOH) within 6 months prior to screening. Medication Overuse is defined as:

  • Use of opioids, including partial agonists, on ≥ 4 days/month, or

  • Use of barbiturates ≥4 days/month

• Current or prior treatment for epilepsy

• History of cerebrovascular event (stroke or transient ischemic attack)

• Use of onabotulinumtoxinA injections for the treatment of migraine within 3 months prior to screening.

• Unwilling or unable to abstain from onabotulinumtoxinA injections in the temporal, supraorbital and occipital implant regions

• Occipital, cervical or supraorbital nerve blocks with corticosteroids for headache or pain management within the 3 months prior to screening.

• Presence of cranial, facial, or scalp anatomical abnormalities that, in the investigator’s judgment, would interfere with safe placement or proper positioning of the MySalvia system

• History of prior surgery, scarring, or implanted hardware in the planned supraorbital or occipital implant regions that may compromise surgical access, device placement, or lead pathway integrity

• Concurrent use of any invasive and non-invasive neuromodulation therapy for headache or pain management.

• Previous inadequate response to any implantable neuromodulation device for headache disorder

• 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) Anticipated need for MRI after implantation of the MySalvia System.

• Clinically significant pain conditions other than migraine (e.g. fibromyalgia, chronic low back pain, complex regional pain syndrome), that, in the investigator’s judgment, could confound study assessments.

• Known history or risk factors for impaired wound healing

• Women of childbearing age who are pregnant, nursing, or not using contraception

• Deemed unsuitable for enrollment by the Investigator based on medical history, physical exam, or overall clinical assessment

• Participation or planning to participate in another clinical study

• Pending or approved worker’s compensation claim or ongoing litigation

• Individuals considered vulnerable to coercion or undue influence (including children, prisoners with impaired decision-making capacity, or others requiring additional safeguards per 21 CFR 50 and 45 CFR 46).

Exclusion criteria to be assessed at the end of the screening phase and to be confirmed prior to the implant procedure:

• Opioid use ≥ 4 days during the final 28-day baseline period of the eligibility phase

• Barbiturate use ≥ 4 days during the final 28-day baseline period of the eligibility phase

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 06/08/2026. Questions regarding updates should be directed to the study team contact.