Chronic MigraineNCT06554886
A Study Investigating Peripheral Cryoneurolysis in Adults With Chronic Migraine
A study testing Cryoneurolysis in people with Chronic Migraine, run by St. Olavs Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Migraine
- What is being tested?
- Cryoneurolysis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNorway
- Study dates
- 29 Aug 2024to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 18Show fewer
- 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.
Who cannot join
- 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:
- Antidepressant (Amitryptyline, Venlafaxine)
- Antiepileptic (Topiramate or Valproate)
- Beta-blocker (Atenol, Metropolol, Propanolol, Timolol)
Show all 22Show fewer
- 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 a change in type, dosage or dose frequency of preventive headache medications during the baseline period.
- Ongoing abuse of drugs (including narcotics) or alcohol.
- More than 4 days of opioid use per month (including codeine and tramadol), and any use of barbiturates
- Other pain conditions, not intended to be treated in this study, that in the opinion of the investigator could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints.
- High probability of deterioration due to other medical conditions, that in the opinion of the investigator may confound outcome assessment.
- Other coexisting current medical conditions, including, but not limited to, bleeding diathesis and thrombophilia, that presents excess procedural risk, in the opinion of the investigator.
- Abnormal pain behavior, inappropriate medication use and/or unresolved psychiatric illness, that in the opinion of the investigator are significant enough to impact perception of pain, compliance with intervention and/or ability to evaluate treatment outcome.
- Anomaly or trauma which renders the planned procedure difficult.
- Subject currently has an active abscess or a local infection at the site of intervention based on present symptoms.
- Subject has been diagnosed with any major infectious processes such as osteomyelitis, or primary or secondary malignancies involving skull or site of intervention that have been active or required treatment in the past 6 months.
- Patients with any kind of conductive implant with contraindication for nerve stimulation.
- The subject is not competent to consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Chronic Migraine
- Being tested
- Cryoneurolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryoneurolysisDevice
Cryoneurolysis
| Study group | Role | What they receive |
|---|---|---|
| Active treatment | Experimental | Cryoneurolysis Receives: Device: Cryoneurolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache days - severe and moderate
Difference in change in mean monthly headache days with moderate or severe intensity
Measured: Weeks 5 - 8 post intervention versus baseline
Safety - AE and SAE
Occurrence of treatment-emergent AE and SAE
Measured: 8 weeks post-intervention
Secondary outcomes (6)
Headache days - any intensity
Difference in change in mean monthly headache days with any intensity
Measured: Weeks 5 - 8 post intervention versus baseline
Migraine days
Difference in change in mean monthly migraine days
Measured: Weeks 5 - 8 post intervention versus baseline
Responders 30%
Number of 30% responders
Measured: Weeks 5 - 8 post-intervention
Responders 50%
Number of 50% responders
Measured: Weeks 5 - 8 post-intervention
Headache Intensity
Difference in the mean monthly headache intensity with a 11 point VAS scale as registered in headache diary
Measured: Weeks 5 - 8 post intervention versus baseline
Medication consumption
Difference in mean monthly days with acute medication consumption as registered in headache diary
Measured: Weeks 5 - 8 post intervention versus baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start29 Aug 2024
- Primary completion28 May 2025
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic MigraineStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel F Bratbak, PhD, Principal investigator, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06554886
- Sponsor's protocol ID
- 727678
- Status last verified
- Aug 2026
- First submitted
- 24 Jun 2024
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Pilot Study Investigating the Safety and Efficacy of a Percutaneous Peripheral Cryoneurolysis Therapy in Medically Resistant Chronic Migraine
- ClinicalTrials.gov ID
- NCT06554886
- Acronym / sponsor ID
- 727678
- Conditions
- Chronic Migraine
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Study start
- 29 Aug 2024 (actual)
- Primary completion
- 28 May 2025 (actual)
- Study completion
- May 2027 (estimated)
- First posted
- 15 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active treatment | Experimental | Device: CryoneurolysisCryoneurolysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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.
Key exclusion criteria (22 listed)
- 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:
- Subject has had a change in type, dosage or dose frequency of preventive headache medications during the baseline period.
- Ongoing abuse of drugs (including narcotics) or alcohol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CryoneurolysisCryoneurolysis | Device | Active treatment |
Primary outcome
Headache days - severe and moderate
Time frame: Weeks 5 - 8 post intervention versus baseline
Difference in change in mean monthly headache days with moderate or severe intensity
Safety - AE and SAE
Time frame: 8 weeks post-intervention
Occurrence of treatment-emergent AE and SAE
6 secondary outcomes
Headache days - any intensity
Time frame: Weeks 5 - 8 post intervention versus baseline
Migraine days
Time frame: Weeks 5 - 8 post intervention versus baseline
Responders 30%
Time frame: Weeks 5 - 8 post-intervention
Responders 50%
Time frame: Weeks 5 - 8 post-intervention
Headache Intensity
Time frame: Weeks 5 - 8 post intervention versus baseline
Medication consumption
Time frame: Weeks 5 - 8 post intervention versus baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel F Bratbak, PhD principal investigator
St. Olavs Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryoneurolysis in people with Chronic Migraine, run by St. Olavs Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache days - severe and moderate (time frame: Weeks 5 - 8 post intervention versus baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.