Actively Recruiting
A Study Investigating Peripheral Cryoneurolysis in Adults With Chronic Migraine
Led by St. Olavs Hospital · Updated on 2025-06-24
12
Participants Needed
1
Research Sites
126 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study Investigating Peripheral Cryoneurolysis in Adults With Chronic Migraine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must be 18 years at the time of signing the informed consent
- Migraine, with or without aura, fulfilling ICHD III criteria 1.3 for chronic migraine, verified by a neurologist
- History of at least 8 debilitating headache days per month for 3 consecutive months
- Chronic migraine for at least 1 year prior to inclusion
- Episodic migraine started before age 50 and chronic migraine before age 65
- Pharmacologically resistant to at least 3 classes of migraine drugs including antidepressants, antiepileptics, beta-blockers, calcium channel blockers, CGRP pathway drugs, ACE inhibitors or angiotensin II blockers, or OnabotulinumtoxinA
- No change in preventive headache medication type, dosage, or frequency within 3 months before baseline
- No oral or injectable steroid treatment within 8 weeks prior to baseline and agreement to avoid steroids during baseline and 8 weeks post-intervention
- Agreement to maintain current preventive headache medication regimen during baseline and 8 weeks after intervention
- Suitable candidate for study intervention based on investigator judgment
- Capable of giving signed informed consent and complying with study requirements
You will not qualify if you...
- Unable to differentiate migraine from other headaches
- Secondary headache conditions except medication overuse headache
- Minimal or no response to more than 6 adequate trials of prophylactic migraine treatments
- Change in preventive headache medication during baseline period
- Ongoing drug or alcohol abuse
- Use of opioids more than 4 days per month or any barbiturates
- Other pain conditions interfering with study procedures or pain reporting
- Medical conditions likely to cause deterioration affecting outcome assessment
- Coexisting medical conditions posing excess procedural risk
- Abnormal pain behavior, inappropriate medication use, or unresolved psychiatric illness impacting study compliance
- Anomaly or trauma complicating the procedure
- Active abscess or local infection at intervention site
- Major infectious processes or malignancies involving skull or intervention site within past 6 months
- Conductive implants contraindicated for nerve stimulation
- Incompetence to consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
St. Olavs hospital
Trondheim, Norway
Actively Recruiting
Research Team
D
Daniel F Bratbak, PhD
CONTACT
T
Tore W Meisingset, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here