BridgeMD
New treatment option for Chronic Migraine
Official title A Study Investigating Peripheral Cryoneurolysis in Adults With Chronic Migraine
ClinicalTrials.gov ID: NCT06554886
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- History of 8 debilitating headache days per month for at least 3 consecutive months. Debilitating headache is defined as headache causing serious...
- 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.
You likely can't join if
- 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...
- Antidepressant (Amitryptyline, Venlafaxine)
- Antiepileptic (Topiramate or Valproate)
- Beta-blocker (Atenol, Metropolol, Propanolol, Timolol)
See the full eligibility criteria
Who can 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...
- 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 how well it works, lack of side effects and/or contraindications to at least 3 of the following drug classes
- 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.
- people 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...
- 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.
What rules you out
- 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)
- 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...
- 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...
- Patients with any kind of conductive implant with contraindication for nerve stimulation.
- The subject is not competent to consent
The study team makes the final eligibility decision.
Where it's taking place
- Trondheim, Norway
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Trondheim, Norway. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.