None listed
Conditions
Brief summary
Middle meningeal artery is an important part of the trigeminovascular system and may be important in migraine pathophysiology. By blocking blood flow to this artery migraine headaches may be reduced in frequency or severity.
Interventions
Dilatation of the middle meningeal artery is linked with headaches in migraine patients.
This phase I pilot study assesses the safety and efficacy of bilateral middle meningeal artery embolisation in chronic migraine patients.
The middle meningeal artery will be permanently occluded using a minimally invasive endovascular approach using precipitating hydrophobic injectable liquid (PHIL) embolic (< 1ml) by an investigating neurointerventionalist. For 28 days before and 90 days following bilater
Dilatation of the middle meningeal artery is linked with headaches in migraine patients. This phase I pilot study assesses the safety and efficacy of bilateral middle meningeal artery embolisation in chronic migraine patients. The middle meningeal artery will be permanently occluded using a minimally invasive endovascular approach using precipitating hydrophobic injectable liquid (PHIL) embolic (< 1ml) by an investigating neurointerventionalist. For 28 days before and 90 days following bilateral middle meningeal artery occlusion, subjects will complete daily headache assessments using a mobile application (~ 3 minutes). Compliance will be monitored by trial staff.
Sponsors
South West Sydney - Local Health District
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
18 years of age and over. < 50 years of age at onset of migraine 2 or more years of history of chronic migraine 8 or more migraine days and at least 15 headaches per month Failure to respond to at least four classes of migraine medicines On stable migraine medication treatment Able to use the eDiary on a mobile phone. Not pregnant and not planning to become pregnant in the next 3 months
Exclusion criteria
History of migraine accompanied by diplopia or decreased consciousness Confounding and clinically significant pain syndrome Non-migraine headache syndrome Psychiatric conditions that are uncontrolled or untreated History of addiction Use of opioids more than 10 days a month Iodine allergy Female patients planning on becoming pregnant
Outcome results
None listed