Enduring Migraine Benefit From Responsive Artery Coil Embolization (EMBRACE): A Single-Site, Non-Significant Risk Pilot Study of Middle Meningeal Artery Embolization Using FDA-Cleared Coils for Refractory Episodic Migraine
Cortex Neurovascular
Summary
This single-site, open-label pilot study evaluates the safety, feasibility, and potential durability of the TEMMA procedure (Targeted Embolization for Migraine Management), an endovascular treatment strategy targeting meningeal arterial contributors to migraine. Adults aged 18-60 with refractory migraine despite prior preventive therapies are eligible. The study assesses migraine outcomes over 12 months using patient-reported headache frequency, pain intensity, acute medication use, migraine-related disability (MIDAS), and quality-of-life measures (MSQ v2.1).
Description
This is an investigator-initiated, prospective, single-site, open-label pilot study designed to evaluate the safety, feasibility, and potential durability of the TEMMA procedure (Targeted Embolization for Migraine Management), an endovascular treatment approach targeting meningeal arterial contributors to migraine symptoms. TEMMA represents a structured clinical program applying endovascular treatment principles to patients with refractory migraine. Participants undergo a baseline assessment period that includes prospective headache diary collection, capturing headache presence, pain intensit…
Eligibility
- Age range
- 18–60 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age 18-60 years * Diagnosis of migraine (with or without aura) -≥8 headache days per month * Failure of ≥2 preventive medication classes * Ability to complete electronic headache diary and surveys * Ability to provide informed consent Exclusion Criteria: * Secondary headache disorders * Prior MMA embolization * Contraindication to angiography or embolization * Pregnancy * Inability to comply with follow-up
Interventions
- DeviceTEMMA Endovascular Treatment
Endovascular treatment targeting meningeal arterial contributors to migraine performed as part of the TEMMA procedure (Targeted Embolization for Migraine Management) using FDA-cleared devices. Procedural techniques and adjunctive assessments are individualized at the discretion of the treating physician and are not standardized within the study.
Location
- Cortex Neurovascular / TRA UnionTacoma, Washington