EMBRACE-OBS: Single-Site Observational Registry of Patient-Reported Outcomes Following MMA Embolization for Migraine

EMBRACE-OBS is the first phase of the EMBRACE research program and is conducted as a single-site observational registry at Cortex Neurovascular.

Migraine is a prevalent neurological disorder that can significantly affect quality of life and daily functioning. Middle meningeal artery (MMA) embolization is performed using FDA-cleared embolic devices. When used for migraine, the procedure is performed at the discretion of the treating physician as part of routine clinical care and independent of research participation.

The purpose of this registry is to access and analyze clinical and patient-reported outcome data already collected through routine clinical care in patients who have undergone or plan to undergo MMA embolization for migraine. The study does not influence clinical decision-making, procedural technique, device selection, or follow-up care.

The primary objective is to describe changes in patient-reported headache frequency and severity over time following MMA embolization performed as part of routine clinical care.

Secondary objectives include describing changes in acute headache medication use, migraine-related disability, quality-of-life measures, medication use patterns, temporal patterns of symptom change, and the real-world safety profile of the procedure as reflected by reported adverse events and complications.

Patient follow-up occurs through routine clinical care. Data accessed for this registry may include headache diaries, HIT-6 scores, clinical information, procedural information, medication use, and outcomes documented during routine clinical follow-up visits. No study-mandated interventions, procedures, visits, or assessments are performed. The research activity consists solely of accessing and analyzing information already documented during routine care.

EMBRACE-OBS is conducted under a separate IRB-approved protocol (Solutions IRB Study 2026-Jun-1013). A separate interventional phase of the EMBRACE research program (EMBRACE-Full; NCT07313800) may be conducted in the future under appropriate regulatory approvals.

• Middle Meningeal Artery Embolization (Procedure): Middle meningeal artery (MMA) embolization performed as part of routine clinical care at the discretion of the treating physician. The procedure is independent of study participation and is not assigned by the study protocol. The research activity consists solely of accessing and analyzing data already documented through routine clinical care.

Primary outcomes

• Change in Patient-Reported Headache Frequency [Baseline and 12 Months]: Change in patient-reported headache frequency, measured as headache days per month, from baseline to 12 months following middle meningeal artery (MMA) embolization performed as part of routine clinical care.

Secondary outcomes

• Change in HIT-6 Score [Baseline and 12 Months]: Change in migraine-related disability as assessed by the Headache Impact Test (HIT-6) score (range: 36-78; higher scores indicate greater headache impact/worse outcome) documented during routine clinical care.

Sex: All, ages: 18 Years to 64 Years

Inclusion Criteria:

* Adults aged 18 to 64 years
* Diagnosis of migraine
* Have undergone or plan to undergo middle meningeal artery (MMA) embolization as part of routine clinical care, independent of study participation
* Able and willing to provide informed consent
* Able to read and understand English sufficiently to complete informed consent and patient-reported outcome assessments

Exclusion Criteria:

* Age under 18 years
* Pregnancy at the time of enrollment
* Inability to provide informed consent
* Inability to read and understand English sufficiently to complete informed consent and patient-reported outcome assessments
* Insufficient clinical or patient-reported outcome data for the planned analyses