A Study Investigating Peripheral Cryoneurolysis in Adults With Chronic Migraine

Exclusion Criteria

• •1. Subject is unable to differentiate migraine from other concomitant headaches.
• •2. Subject with secondary headache conditions, with the exception of medication overuse headache.
• •3. Subject that, in the opinion of the investigator, has had no or minimal response to more than 6 adequate trials of prophylactic migraine treatment of the following drug classes:
• •1. Antidepressant (Amitryptyline, Venlafaxine)
• •2. Antiepileptic (Topiramate or Valproate)
• •3. Beta-blocker (Atenol, Metropolol, Propanolol, Timolol)
• •4. Calcium channel blockers (Flunarizine or Cinnarizine)
• •5. Drugs acting on the CGRP pathway (Monoclonal antibodies and gepants)
• •6. Angiotensin-converting enzyme inhibitors (Lisinopril) or angiotensin II receptor blocker (Candesartan)
• •7. OnabotulinumtoxinA
• •4. Subject has had a change in type, dosage or dose frequency of preventive headache medications during the baseline period.
• •5. Ongoing abuse of drugs (including narcotics) or alcohol.
• •6. More than 4 days of opioid use per month (including codeine and tramadol), and any use of barbiturates
• •7. Other pain conditions, not intended to be treated in this study, that in the opinion of the investigator could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints.
• •8. High probability of deterioration due to other medical conditions, that in the opinion of the investigator may confound outcome assessment.
• •9. Other coexisting current medical conditions, including, but not limited to, bleeding diathesis and thrombophilia, that presents excess procedural risk, in the opinion of the investigator.
• •10. Abnormal pain behavior, inappropriate medication use and/or unresolved psychiatric illness, that in the opinion of the investigator are significant enough to impact perception of pain, compliance with intervention and/or ability to evaluate treatment outcome.
• •11. Anomaly or trauma which renders the planned procedure difficult.
• •12. Subject currently has an active abscess or a local infection at the site of intervention based on present symptoms.
• •13. Subject has been diagnosed with any major infectious processes such as osteomyelitis, or primary or secondary malignancies involving skull or site of intervention that have been active or required treatment in the past 6 months.
• •14. Patients with any kind of conductive implant with contraindication for nerve stimulation.
• •15. The subject is not competent to consent