EMBRACE Study: Enduring Migraine Benefit From Responsive Artery Coil Embolization

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 intensity, and acute medication use, along with baseline migraine-related disability and quality-of-life assessments. Endovascular treatment is performed as part of the TEMMA program using FDA-cleared devices in accordance with institutional clinical practice. Procedural techniques, vessel selection, materials, adjunctive assessments, and treatment sequencing are determined by the treating physician and are not fully standardized within this pilot study.

Adjunctive assessments, which may include intra-procedural physiologic or pharmacologic evaluations, may be performed at the discretion of the treating physician to inform clinical decision-making but are not required for study participation and are not used as mandatory eligibility criteria.

Participants are followed longitudinally with serial headache diary data and standardized patient-reported outcome measures collected at predefined intervals through 12 months following treatment. The primary endpoint is change in monthly headache days compared with baseline. Secondary endpoints include changes in headache intensity, acute medication use, migraine-related disability, quality of life, and durability of symptom improvement.

Safety is monitored throughout the study through adverse event reporting with independent physician oversight.

• Change in Headache Intensity [Срок оценки: Baseline to 12 months post-embolization]
• Change in Acute Medication Use [Срок оценки: Baseline to 12 months post-embolization.]
• Change in Migraine Disability Assessment (MIDAS) Score [Срок оценки: Baseline to 3 months (assessed at 1, 3, 6, and 12 months).]
• Change in Migraine-Specific Quality of Life Questionnaire (MSQ v2.1) Score [Срок оценки: Baseline to 3 months (assessed at 1, 3, 6, and 12 months).]
• Time to Symptom Recurrence Following Lidocaine Testing [Срок оценки: Up to 4 weeks post-lidocaine testing.]
• Time to Symptom Recurrence Following Embolization [Срок оценки: Up to 12 months post-embolization.]