EMBRACE-OBS: Single-Site Observational Registry of Patient-Reported Outcomes Following MMA Embolization for Migraine
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-64
SponsorCortex Neurovascular
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Middle Meningeal Artery Embolization
Procedure/SurgeryMiddle 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Migraine Patients Undergoing MMA Embolization1 intervention
Trial outcomes
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.
Time frame
Baseline and 12 MonthsSecondary 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.
Time frame
Baseline and 12 MonthsSponsors and contacts
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Source ClinicalTrials.gov