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

NCT07652034 | Not Yet Recruiting

• 1 other identifier: EMBRACE-OBS
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

EMBRACE-OBS is the first phase of the EMBRACE research program. This single-site observational registry accesses and analyzes patient-reported outcome data already collected through routine clinical care from adults with migraine who have undergone or plan to undergo middle meningeal artery (MMA) embolization. The study describes changes in headache frequency, headache severity, medication use, migraine-related disability, quality of life, and reported adverse events over time without influencing clinical care.

Conditions

Migraine Disorders; Chronic Migraine Headache; Migraine

Keywords

Middle Meningeal Artery Embolization; MMA Embolization; Migraine; Headache; Patient-Reported Outcomes; HIT-6; Observational Registry; Neurointervention; EMBRACE-OBS

Outcome Measures

Primary Outcomes (1)

• Change in Patient-Reported Headache Frequency

  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.

  Baseline and 12 Months

Secondary Outcomes (1)

• Change in HIT-6 Score

  Baseline and 12 Months

Study Arms (1)

Migraine Patients Undergoing MMA Embolization

Adults aged 18 to 64 years with a diagnosis of migraine who have undergone or plan to undergo middle meningeal artery (MMA) embolization as part of routine clinical care. Participants are enrolled in an observational registry that accesses and analyzes clinical and patient-reported outcome data already documented through routine care. Study participation does not influence clinical management, procedural technique, device selection, or follow-up.

Procedure: Middle Meningeal Artery Embolization

Interventions

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.

Migraine Patients Undergoing MMA Embolization

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adults aged 18 to 64 years with a diagnosis of migraine who have undergone or plan to undergo middle meningeal artery (MMA) embolization as part of routine clinical care at Cortex Neurovascular. Participants are enrolled in a prospective observational registry that accesses and analyzes clinical and patient-reported outcome data already documented during routine care. Enrollment does not influence clinical decision-making, procedural technique, device selection, or follow-up care.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cortex Neurovascular: lead

Study Sites (1)

Cortex Neurovascular / TRA Union

Tacoma, Washington, 98405, United States

Location

MeSH Terms

Conditions

Migraine Disorders; Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Dennis Wang, Principal Investigator, MD

CONTACT

253-284-0841; dwang@cortexmgmt.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 16, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: June 18, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)