Clinical Trials

Inclusion Criteria

• ≥  22 years of age.
• Have migraine onset at ≤ 50 years of age.
• Have a history of migraine for ≥ 12 months prior to screening as defined by:
  • iCHD-3 criteria and laid out in Appendix A or;
  • Investigator clinical judgment, if not covered by an iCHD-3 diagnosis.
• Have ≥15 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 (as defined in the primary efficacy endpoint).
• Fulfill the criteria for chronic migraine (CM) in the medical history and during the 28-day screening period as defined in the iCHD-34 and laid out in Appendix A.
• 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.
• Maintain a stable use of preventive(s) migraine medication for ≥ 3 months before screening.
• Demonstrate ≥ 80% compliance with the headache diary during the screening period by entering headache data on a minimum of 22 out of 28 days.
• 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.
• Be able to give voluntary, written informed consent to participate in this study.

Exclusion Criteria

• Type of headache or migraine other than RCM including the following:
  • Post-traumatic headache (e.g., battlefield, accidents, etc.);
  • Regular intake of opioids (including codeine) of ≥ 8 days/month in the past 3 months and during the 28-day screening/baseline phase and cannot be accounted for by another diagnosis;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;
  • Report experiencing unremitting, continuous headaches with no relief;
  • 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.
• History of treatments that could confound the results of the ShiraTronics Migraine Therapy:
  • Previously implanted neurostimulator to stimulate the greater occipital and/or supraorbital nerves to treat headache;
  • 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.
• Have had any cervical radiofrequency ablation within 12 months.
• Subjects with recent brain or facial trauma occurring less than 3 months prior to the Baseline Visit.
• 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.
• Subject has other implanted electrical stimulation device(s) or any metallic implant (excluding dental implants) including:
  • Cardiac pacemakers or defibrillators;
  • Cochlear implant;
  • CSF shunt ;
  • Surgical clip (above the shoulder line);
  • Intrathecal pumps;
  • Spinal cord stimulator .
• Use of nerve blocks, acupuncture, implantable neurostimulator and/or transcranial magnetic stimulation) for migraine within 3 months prior to screening and after receiving implant system.
• Any pre-existing or requirement of emergent surgery/procedure that may interfere or confound the results of the ShiraTronics Migraine Therapy.
• Any known requirement for an MRI scan subsequent to implant of the neurostimulator.
• Current or history of following comorbidities:
  • Clinically significant psychiatric illnesses, including suicide attempt, or suicidal ideation with a specific plan in the past 2 years;
  • Cancer in the past 5 years, except for appropriately treated nonmelanoma skin carcinoma;
  • Subjects with uncontrolled epilepsy who are currently undergoing treatment of epilepsy;
  • Subjects with documented history of cerebrovascular accident (CVA);
  • Have a current diagnosis or condition that presents excess risk for performing the procedure, as determined clinically by the Investigator;
  • Substance use disorder of at least moderate severe for substances such as; alcohol, recreational marijuana, or illicit drugs during the past 2 years. See Appendix C for definition.
• Unable to participate or successfully complete the study, in the opinion of the investigator, for any of the following reasons:
  • in custody due to an administrative or a legal decision, under guardianship, or institutionalized or;
  • unable to be contacted in case of emergency or;
  • has any other condition, which, in the opinion of the investigator, makes the patient inappropriate for inclusion in the study.
• Anatomy not suitable for placement of ShiraTronics System components.
• Are currently a study center or Sponsor employee who is directly involved in the study or the relative of such an employee.
• Pregnant or lactating female or planning a pregnancy during participation in the study.
• Patient with life expectancy of less than 1.5 years.
• Currently participating in or planning to participate in other investigational drug or device studies that may interfere or confound the results of the ShiraTronics Migraine Therapy.

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

Eligibility last updated 2/20/24. Questions regarding updates should be directed to the study team contact.