A Study Investigating Peripheral Cryoneurolysis in Adults With Chronic Migraine
ConditionChronic Migraine
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSt. Olavs Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Subject is unable to differentiate migraine from other concomitant headaches.
Subject with secondary headache conditions, with the exception of medication overuse headache.
Antidepressant (Amitryptyline, Venlafaxine)
Antiepileptic (Topiramate or Valproate)
Trial design
Treatments tested in this trial
- Cryoneurolysis
Treatment groups
12 Participants
are divided into 1 treatment groupLocations
1St. Olavs hospital Trondheim Norway
Sponsors and collaborators
St. Olavs Hospital
Lead sponsor
Source ClinicalTrials.gov