EMBRACE-OBS: Single-Site Observational Registry of Patient-Reported Outcomes Following MMA Embolization for Migraine (EMBRACE-OBS)
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
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Dennis Wang, Principal Investigator, MD
- 電話番号：253-284-0841
- メール：dwang@cortexmgmt.com
研究場所
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Washington
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Tacoma、Washington、アメリカ、98405
- Cortex Neurovascular / TRA Union
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コンタクト：
- Dennis Wang, MD
- 電話番号：253-284-0841
- メール：dwang@cortexmgmt.com
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コンタクト：
-
主任研究者：
- Dennis O Wang, MD
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参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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.
|
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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Patient-Reported Headache Frequency
時間枠：Baseline and 12 Months
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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.
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Baseline and 12 Months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in HIT-6 Score
時間枠：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.
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Baseline and 12 Months
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- EMBRACE-OBS
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。