A Study Investigating Peripheral Cryoneurolysis in Adults With Chronic Migraine (NCT06554886) | Clinical Trial Compass
RecruitingNot Applicable
A Study Investigating Peripheral Cryoneurolysis in Adults With Chronic Migraine
Norway12 participantsStarted 2024-08-29
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Headache days - severe and moderate
Timeframe: Weeks 5 - 8 post intervention versus baseline
. 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)
Exclusion criteria
. Subject is unable to differentiate migraine from other concomitant headaches.
. Subject with secondary headache conditions, with the exception of medication overuse headache.
. 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: