Migraine Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with chronic migraine, meaning they experience 15 or more headache days per month for more than 3 months, with at least 8 of those days being migraine days, confirmed by keeping a headache diary for 4 weeks before the study starts.
• People for whom at least 2 different types of migraine prevention medications (such as beta-blockers, anti-seizure medications, or antidepressants) have not worked well enough — meaning those medications did not reduce migraine days by at least half — when taken at full recommended doses for a sufficient period of time.
• People who have been on a stable migraine prevention medication routine for at least 4 weeks before joining.
• People whose migraines cause moderate to severe impact on daily life, as measured by a standard questionnaire called the MIDAS score (a score of 11 or higher).
• People who are able and willing to fill in a daily headache diary throughout the entire study.
• People who are able to give written consent to participate.
• People who responded positively to a specific diagnostic nerve block procedure (a sphenopalatine ganglion block using a local anaesthetic called lidocaine), meaning the procedure reduced their pain by at least 50% within 30 to 60 minutes.

Who may not be able to join:

• People whose headaches are thought to be caused or worsened by overuse of pain medications — for example, using simple pain relievers 15 or more days per month, or using triptans, opioids, or combination painkillers 10 or more days per month, for more than 3 months.
• People who have certain other types of headache disorders, such as cluster headache, hemiplegic migraine, migraine with brainstem aura, or chronic tension-type headache occurring more than 10 days per month.
• People who have had certain nerve procedures in the relevant area of the head (such as a sphenopalatine ganglion block, radiofrequency treatment, or nerve stimulation) within the past 6 months, or certain other nerve procedures near the back or front of the head within the past 3 months.
• People who have used Botox (botulinum toxin) or CGRP antibody medications (a type of newer migraine prevention injection) within the past 3 months.
• People with certain serious mental health conditions in the past 12 months, including active psychosis, current episodes of bipolar disorder, severe depression with thoughts of suicide, dementia, or substance use disorder; or people whose depression score on a standard questionnaire is very high, or whose thinking difficulties might affect their ability to accurately report symptoms.
• People who have a cardiac pacemaker, implanted heart device (ICD), neurostimulator, cochlear implant, or who have undergone electroconvulsive therapy (ECT).
• People with poorly controlled high blood pressure, or a history of stroke, brain aneurysm, or high risk of heart or blood vessel problems.
• People who are pregnant or breastfeeding, or who have started, stopped, or changed hormonal contraception within the past 3 months.
• People with blood clotting problems — such as low platelet counts or blood that takes too long to clot — or who are taking blood-thinning medications that cannot safely be paused (confirm with trial site).
• People who do not wish to participate.

Important: Always verify eligibility with the trial site directly before applying.