Actively Recruiting
An Open Label Pilot Study Investigating the Safety and Efficacy of a Percutaneous Peripheral Cryoneurolysis Therapy in Medically Resistant Chronic Migraine
Led by St. Olavs Hospital · Updated on 2025-06-24
12
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a freezing technique called cryoneurolysis to see if it helps relieve pain in adults with chronic migraine, a condition causing moderate to severe headaches. The study aims to measure headache relief after treatment and gather other important participant information to assess the potential of this technique as a treatment option. This is an open label pilot study conducted by St. Olavs Hospital focusing on medically resistant chronic migraine. Participants will use a headache diary for at least 4 weeks before receiving cryoneurolysis treatment. After the initial treatment, those with recurring headaches may receive further treatment as needed for up to two years. The study involves administering the cryoneurolysis device to target peripheral nerves to reduce migraine symptoms. During the study, participants will record headache severity and frequency in their diaries both before and after treatment. Researchers will monitor headache days with moderate and severe intensity, migraine days, medication use, and any adverse events over an 8-week period post-intervention. The total participation may last up to two years with ongoing follow-up for safety and treatment effectiveness.
CONDITIONS
Brief 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
- Diagnosed with migraine, with or without aura, meeting criteria 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
- Resistant to medication as defined by lack of efficacy, tolerability, or contraindications to at least 3 specified drug classes
- No change in preventive headache medication type, dosage, or frequency within 3 months prior to baseline
- No steroid treatment orally or injections within 8 weeks prior to baseline and agree to avoid steroids during baseline and 8 weeks after intervention
- Agree to maintain current preventive headache medications during baseline and 8 weeks post-intervention
- Suitable candidate for study intervention based on investigator's clinical judgment
- Capable of giving informed consent and complying with study requirements
You will not qualify if you...
- Unable to distinguish migraine from other headaches
- Secondary headache conditions except medication overuse headache
- Minimal or no response to more than 6 adequate trials of specified 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 barbiturate use
- Other pain conditions interfering with study procedures or pain reporting
- High risk of deterioration from other medical conditions affecting outcome
- Coexisting medical conditions posing excess procedural risk
- Abnormal pain behavior, inappropriate medication use, or unresolved psychiatric illness impacting pain perception or compliance
- Physical anomalies or trauma complicating the procedure
- Active abscess or local infection at intervention site
- Recent major infections or malignancies at intervention site
- Contraindications due to conductive implants
- Incompetent to provide consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment session
Participants receive percutaneous peripheral cryoneurolysis therapy as the study intervention.
1 visit (in-person)
Duration - 8 weeks
Participants are monitored for safety and efficacy outcomes following the cryoneurolysis intervention.
Weekly visits for up to 8 weeks
Trial Site Locations
Total: 1 location
1
St. Olavs hospital
Trondheim, Norway
Actively Recruiting
Research Team
D
Daniel F Bratbak, PhD
T
Tore W Meisingset, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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