An Open Label Pilot Study Investigating the Safety and Efficacy of a Percutaneous Peripheral Cryoneurolysis Therapy in Medically Resistant Chronic Migraine
The trial is a research study that tests a freezing technique called cryoneurolysis to see if it helps relieve pain in adults with chronic migraine. Chronic migraine is a condition that causes moderate to severe headache. In this study, the investigators want to evaluate the freezing technique in chronic migraine. The main goal is to see how much headache relief is experienced after receiving the treatment. The investigators will also record other important information about the participants. The study is looking to recruit 12 adults with chronic migraine to take part in the study. Participants will register their headache burden in a headache diary for at least 4 weeks before receiving treatment with the freezing technique. They will continue to register headache in the headache diary during the follow-up. After this initial treatment, participants with recurring headache can receive treatment as needed for up to two years. The results of this study will help us decide if the freezing technique may be viable treatment option for chronic migraine and enable us plan for further studies on this treatment.
• Participant must be 18 years at the time of signing the informed consent
• Migraine, with or without aura, fulfilling the International Classification of Headache Disorders (ICHD) III criteria 1.3. for chronic migraine at time of inclusion, verified by a neurologist
• History of 8 debilitating headache days per month for at least 3 consecutive months. Debilitating headache is defined as headache causing serious impairment to conduct activities of daily living despite the use of pain-relief drugs with established efficacy at the recommended dose and taken early during the attack; failure of at least two different triptans is required.
• Chronic migraine at least for a period of 1 year prior to inclusion
• Debut of episodic migraine before the age of 50, and chronic migraine before the age of 65.
• The condition is pharmacologically resistant as defined in EHF guidelines as lack of efficacy, lack of tolerability and/or contraindications to at least 3 of the following drug classes
∙ Antidepressant (Amitryptyline, Venlafaxine)
‣ Antiepileptic (Topiramate or Valproate)
‣ Beta-blocker (Atenol, Metropolol, Propanolol, Timolol)
‣ Calcium channel blockers (Flunarizine or Cinnarizine)
‣ Drugs acting on the CGRP pathway (Monoclonal antibodies and gepants)
‣ Angiotensin-converting enzyme inhibitors (Lisinopril) or angiotensin II receptor blocker (Candesartan)
‣ OnabotulinumtoxinA
• Subject has had no change in type, dosage or dose frequency of preventive headache medications \< 3 months prior to baseline/screening, or a minimum of 5 half-lives, whichever is longer.
• Subjects has not been treated with steroids orally or injections \>8 weeks (excluding steroid inhalations or topical treatments) prior to baseline and agrees to refrain from steroids orally or injections during baseline and 8 weeks post-intervention.
• Subject agrees to maintain current preventive headache medication regimens (no change in type, frequency, or dose) during baseline and 8 weeks after the intervention.
⁃ Be an appropriate candidate for the study intervention required in this study on the basis of the clinical judgment of the investigator
⁃ Capable of giving signed informed consent as which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.