A PIVOTAL STUDY EVALUATING SAFETY and EFFICACY of the SHIRATRONICS MIGRAINE THERAPY SYSTEM

Inclusion 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 probablemigraine, and minimum of 2 headache-free days/month during the 28-day screeningperiod.

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 responseor no access to, or are intolerant, unwilling, or contraindicated to Onabotulinumtoxin A (Botox) therapy, and One of the medications that belong to Calcitonin GeneRelated Peptide Monoclonal antibodies (CGRP) therapy or CGRP antagonist therapy.

7. Maintain a stable use of preventive(s) migraine medication for ≥ 3 months beforescreening. Subjects receiving OnabotunlinumtoxinA must stop therapy ≥ 3 months priorto screening visit.

8. Demonstrate ≥ 80% compliance with the headache diary during the screening period byentering 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 forthe follow-up evaluation, as specified in this protocol.

10. Be able to give voluntary, written informed consent to participate in this study.

Exclusion Criteria:

1. Type of headache or migraine other than RCM including the following:

2. Post-traumatic headache (e.g., battlefield, accidents, etc.).

3. Regular intake of opioids (including codeine) of ≥ 8 days in the past 3 monthsand during the 28-day screening/baseline phase and cannot be accounted for byanother diagnosis.

4. Regular intake of Barbiturates for ≥ 5 days/month in the past 3 months andduring the 28-day screening/baseline phase and cannot be accounted for byanother diagnosis.

5. Report experiencing unremitting, continuous headaches with no relief.

6. Have new daily persistent headache (NDPH) defined by iCHD-3 as persistentheadache, daily from its onset, which is clearly remembered. The pain lackscharacteristic features and may be migraine-like or tension-type like or haveelements of both with a CM subtype.

7. History of treatments that could confound the results of the study

8. Previously implanted neurostimulator to stimulate the greater occipital and/orsupraorbital nerves to treat headache.

9. Have received onabotulinumtoxinA (Botox) for any other medical or cosmeticreasons requiring injections in the head, face, or neck within 3 months priorto screening.

10. Have had any cervical radiofrequency ablation within 12 months.

11. Subjects with recent brain or facial trauma occurring less than 3 months prior tothe Baseline Visit.

12. Subjects that may have received sequential multi-day in-patient parenteral infusionfor the treatment of a migraine condition (e.g., status migrainosus) within theprevious 2 weeks of the initiation of diary screening phase.

13. Subjects with any metallic implant located in the head including CSF shunt andsurgical clip above the shoulder line (excluding dental implants).

14. Subject has other implanted electrical stimulation device(s) including:

15. Cardiac pacemakers or defibrillators

16. Cochlear implant

17. Intrathecal pumps

18. Spinal cord stimulator

19. Other stimulator device

20. Use of nerve blocks, acupuncture, neurostimulation and/or transcranial magneticstimulation) for migraine within 3 months prior to screening and after receivingimplant system.

21. Any pre-existing or requirement of emergent surgery/procedure that may interfere orconfound the results of the study.

22. Any known requirement for an MRI scan subsequent to implant of the neurostimulator.

23. Current or history of following comorbidities:

24. Clinically significant psychiatric illnesses, including suicide attempt, orsuicidal ideation with a specific plan in the past 2 years.

25. Cancer in the past 5 years, except for appropriately treated nonmelanoma skincarcinoma.

26. Have a current diagnosis or condition that presents excess risk for performingthe procedure, as determined clinically by the Investigator.

27. Substance use disorder of at least moderate severe for substances such as;alcohol, recreational marijuana, or illicit drugs during the past 2 years.

28. Unable to participate or successfully complete the study, in the opinion of theinvestigator.

29. Anatomy not suitable for placement of the study device.

30. Are currently a study center or Sponsor employee who is directly involved in thestudy or the relative of such an employee.

31. Pregnant or lactating female or planning a pregnancy during participation in thestudy.

32. Patient with life expectancy of less than 1.5 years.

33. Currently participating in or planning to participate in other investigational drugor device studies that may interfere or confound the results of the study.