Can freezing nerves stop chronic migraine pain?

NCT ID NCT06554886

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time

Summary

This pilot study tests a freezing technique called cryoneurolysis to see if it can ease pain in adults with chronic migraine—a condition causing frequent, severe headaches. Participants will track their headaches in a diary for at least a month before treatment, then receive the freezing procedure. If headaches return, they can get repeat treatments as needed for up to two years. The goal is to measure how much headache relief the technique provides and to gather safety information for future, larger studies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cryoneurolysis (a freezing technique applied to nerves)
What this could lead to
If it works, this freezing technique could offer a new way to ease chronic migraine pain for people who haven't been helped by standard treatments.
What could go wrong
This is a small pilot study, so results may not apply to everyone. The procedure is experimental, and its safety and effectiveness are not yet proven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

12 people

The number who actually took part.

Started

Aug 2024

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Participant must be 18 years at the time of signing the informed consent 2. 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 3. 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. 4. Chronic migraine at least for a period of 1 year prior to inclusion 5. Debut of episodic migraine before the age of 50, and chronic migraine before the age of 65. 6. 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 1. Antidepressant (Amitryptyline, Venlafaxine) 2. Antiepileptic (Topiramate or Valproate) 3. Beta-blocker (Atenol, Metropolol, Propanolol, Timolol) 4. Calcium channel blockers (Flunarizine or Cinnarizine) 5. Drugs acting on the CGRP pathway (Monoclonal antibodies and gepants) 6. Angiotensin-converting enzyme inhibitors (Lisinopril) or angiotensin II receptor blocker (Candesartan) 7. OnabotulinumtoxinA 7. 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. 8. 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. 9. Subject agrees to maintain current preventive headache medication regimens (no change in type, frequency, or dose) during baseline and 8 weeks after the intervention. 10. Be an appropriate candidate for the study intervention required in this study on the basis of the clinical judgment of the investigator 11. 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. Exclusion Criteria: 1. Subject is unable to differentiate migraine from other concomitant headaches. 2. Subject with secondary headache conditions, with the exception of medication overuse headache. 3. 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: 1. Antidepressant (Amitryptyline, Venlafaxine) 2. Antiepileptic (Topiramate or Valproate) 3. Beta-blocker (Atenol, Metropolol, Propanolol, Timolol) 4. Calcium channel blockers (Flunarizine or Cinnarizine) 5. Drugs acting on the CGRP pathway (Monoclonal antibodies and gepants) 6. Angiotensin-converting enzyme inhibitors (Lisinopril) or angiotensin II receptor blocker (Candesartan) 7. OnabotulinumtoxinA 4. Subject has had a change in type, dosage or dose frequency of preventive headache medications during the baseline period. 5. Ongoing abuse of drugs (including narcotics) or alcohol. 6. More than 4 days of opioid use per month (including codeine and tramadol), and any use of barbiturates 7. 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. 8. High probability of deterioration due to other medical conditions, that in the opinion of the investigator may confound outcome assessment. 9. 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. 10. 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. 11. Anomaly or trauma which renders the planned procedure difficult. 12. Subject currently has an active abscess or a local infection at the site of intervention based on present symptoms. 13. 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. 14. Patients with any kind of conductive implant with contraindication for nerve stimulation. 15. The subject is not competent to consent

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • St. Olavs hospital

    Trondheim, Norway

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