Migraine DisordersEMBRACE-OBSNCT07652034
EMBRACE-OBS: Single-Site Observational Registry of Patient-Reported Outcomes Following MMA Embolization for Migraine
An observational study of Migraine Disorders and Chronic Migraine Headache, run by Cortex Neurovascular at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Migraine Disorders, Chronic Migraine Headache, Migraine
- What is being tested?
- Middle Meningeal Artery Embolization
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 1 Jun 2028
- How long will I take part?
- 12 Months
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cortex Neurovascular / TRA Union
Tacoma, Washington, 98405
Dennis Wang, MD, 253-284-0841, dwang@cortexmgmt.com
dwang@cortexmgmt.com
About this study
Official title: Enduring Migraine Benefit From Responsive Artery Coil Embolization - Observational (EMBRACE-OBS): A Single-Site Registry of Patient-Reported Outcomes Following Routine Clinical Care for Migraine
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.
Read the detailed description
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.
- Conditions
- Migraine Disorders, Chronic Migraine Headache, Migraine
- Being tested
- Middle Meningeal Artery Embolization
- Keywords
- Middle Meningeal Artery Embolization, MMA Embolization, Migraine, Headache, Patient-Reported Outcomes, HIT-6, Observational Registry, Neurointervention, EMBRACE-OBS
- Medical subject headings
- Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Middle Meningeal Artery EmbolizationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Middle Meningeal Artery Embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 12 Months
Secondary outcomes (1)
Change in HIT-6 Score
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.
Measured: Baseline and 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start1 Sep 2026
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Cortex Neurovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07652034
- Sponsor's protocol ID
- EMBRACE-OBS
- Acronym
- EMBRACE-OBS
- Status last verified
- Sep 2026
- First submitted
- 11 Jun 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No