EMBRACE Study: Enduring Migraine Benefit From Responsive Artery Coil Embolization

Condition(s) studied

Investigational drug(s) / intervention(s)

TEMMA 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.

Study 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).

Eligibility

Primary outcome measure(s)

• Change in Monthly Headache Days Post-Embolization — Baseline to 12 months post-embolization
  Change from baseline in the number of headache days per month following bilateral middle meningeal artery coil embolization, assessed via SMS-based headache diary.

Trial sites (1)

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