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

16. juni 2026 oppdatert av: Cortex Neurovascular

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

50

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Dennis Wang, Principal Investigator, MD
  • Telefonnummer: 253-284-0841
  • E-post: dwang@cortexmgmt.com

Studiesteder

  • Forente stater
    • Washington
      • Tacoma, Washington, Forente stater, 98405
        • Cortex Neurovascular / TRA Union
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Dennis O Wang, MD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
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.
Fremgangsmåte: Middle Meningeal Artery Embolization
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Patient-Reported Headache Frequency
Tidsramme: 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.
Baseline and 12 Months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in HIT-6 Score
Tidsramme: 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.
Baseline and 12 Months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Cortex Neurovascular

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juli 2026

Primær fullføring (Antatt)

1. juni 2028

Studiet fullført (Antatt)

1. juni 2028

Datoer for studieregistrering

Først innsendt

11. juni 2026

Først innsendt som oppfylte QC-kriteriene

11. juni 2026

Først lagt ut (Faktiske)

16. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • EMBRACE-OBS

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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