A PIVOTAL STUDY EVALUATING SAFETY AND EFFICACY OF THE SHIRATRONICS MIGRAINE THERAPY SYSTEM

Eligibility Criteria

• 1. ≥ 22 years of age.
• 2. Have migraine onset at ≤ 50 years of age.
• 3. Have a history of migraine for ≥ 12 months prior to screening.
• 4. Have 15 - 26 headache days/month, among which ≥ 8 days has the features of probable migraine, and minimum of 2 headache-free days/month during the 28-day screening period.
• 5. Fulfill the criteria for chronic migraine (CM) during the 28-day screening period.
• 6. Have a diagnosis of refractory chronic migraine (RCM), who have inadequate response or no access to, or are intolerant, unwilling, or contraindicated to Onabotulinum toxin A (Botox) therapy, and One of the medications that belong to Calcitonin Gene Related Peptide Monoclonal antibodies (CGRP) therapy or CGRP antagonist therapy.
• 7. Maintain a stable use of preventive(s) migraine medication for ≥ 3 months before screening.
• 8. Demonstrate ≥ 80% compliance with the headache diary during the screening period by entering headache data on a minimum of 22 out of 28 days.
• 9. Be willing and able to comply with all study procedures and return to the clinic for the follow-up evaluation, as specified in this protocol.
• 10. Be able to give voluntary, written informed consent to participate in this study.
• 1. Type of headache or migraine other than RCM including the following:
• 1. Post-traumatic headache (e.g., battlefield, accidents, etc.).
• 2. Regular intake of opioids (including codeine) of ≥ 8 days in the past 3 months and during the 28-day screening/baseline phase and cannot be accounted for by another diagnosis.
• 3. Regular intake of Barbiturates for ≥ 5 days/month in the past 3 months and during the 28-day screening/baseline phase and cannot be accounted for by another diagnosis.
• 4. Report experiencing unremitting, continuous headaches with no relief.
• 5. Have new daily persistent headache (NDPH) defined by iCHD-3 as persistent headache, daily from its onset, which is clearly remembered. The pain lacks characteristic features and may be migraine-like or tension-type like or have elements of both with a CM subtype.
• 2. History of treatments that could confound the results of the study
• 1. Previously implanted neurostimulator to stimulate the greater occipital and/or supraorbital nerves to treat headache.
• 2. Have received onabotulinumtoxinA (Botox) for any other medical or cosmetic reasons requiring injections in the head, face, or neck within 6 months prior to screening.
• 3. Have had any cervical radiofrequency ablation within 12 months.
• 4. Subjects with recent brain or facial trauma occurring less than 3 months prior to the Baseline Visit.
• 5. Subjects that may have received sequential multi-day in-patient parenteral infusion for the treatment of a migraine condition (e.g., status migrainosus) within the previous 2 weeks of the initiation of diary screening phase.
• 6. Subject has other implanted electrical stimulation device(s) or any metallic implant (excluding dental implants) including:
• 1. Cardiac pacemakers or defibrillators
• 2. Cochlear implant
• 3. CSF shunt
• 4. Surgical clip (above the shoulder line)
• 5. Intrathecal pumps
• 6. Spinal cord stimulator
• 7. Use of nerve blocks, acupuncture, neurostimulation and/or transcranial magnetic stimulation) for migraine within 3 months prior to screening and after receiving implant system.
• 8. Any pre-existing or requirement of emergent surgery/procedure that may interfere or confound the results of the study.
• 9. Any known requirement for an MRI scan subsequent to implant of the neurostimulator.
• 10. Current or history of following comorbidities:
• 1. Clinically significant psychiatric illnesses, including suicide attempt, or suicidal ideation with a specific plan in the past 2 years.
• 2. Cancer in the past 5 years, except for appropriately treated nonmelanoma skin carcinoma.
• 3. Have a current diagnosis or condition that presents excess risk for performing the procedure, as determined clinically by the Investigator.
• 4. Substance use disorder of at least moderate severe for substances such as; alcohol, recreational marijuana, or illicit drugs during the past 2 years.
• 11. Unable to participate or successfully complete the study, in the opinion of the investigator.
• 12. Anatomy not suitable for placement of the study device.
• 13. Are currently a study center or Sponsor employee who is directly involved in the study or the relative of such an employee.
• 14. Pregnant or lactating female or planning a pregnancy during participation in the study.
• 15. Patient with life expectancy of less than 1.5 years.
• 16. Currently participating in or planning to participate in other investigational drug or device studies that may interfere or confound the results of the study.