EMBRACE Study: Enduring Migraine Benefit From Responsive Artery Coil Embolization
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TEMMA Endovascular Treatment.
- Who it may be relevant to
- Registry conditions: Migraine Disorders, Refractory Migraine, Chronic Migraine. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Enduring Migraine Benefit From Responsive Artery Coil Embolization (EMBRACE): A Single-Site, Non-Significant Risk Pilot Study of Middle Meningeal Artery Embolization Using FDA-Cleared Coils for Refractory Episodic Migraine
Overview
This single-site, open-label pilot study evaluates the safety, feasibility, and potential durability of the TEMMA procedure (Targeted Embolization for Migraine Management), an endovascular treatment strategy targeting meningeal arterial contributors to migraine. Adults aged 18-60 with refractory migraine despite prior preventive therapies are eligible. The study assesses migraine outcomes over 12 months using patient-reported headache frequency, pain intensity, acute medication use, migraine-related disability (MIDAS), and quality-of-life measures (MSQ v2.1).
Detailed description
This is an investigator-initiated, prospective, single-site, open-label pilot study designed to evaluate the safety, feasibility, and potential durability of the TEMMA procedure (Targeted Embolization for Migraine Management), an endovascular treatment approach targeting meningeal arterial contributors to migraine symptoms. TEMMA represents a structured clinical program applying endovascular treatment principles to patients with refractory migraine.
Participants undergo a baseline assessment period that includes prospective headache diary collection, capturing headache presence, pain intensity, and acute medication use, along with baseline migraine-related disability and quality-of-life assessments. Endovascular treatment is performed as part of the TEMMA program using FDA-cleared devices in accordance with institutional clinical practice. Procedural techniques, vessel selection, materials, adjunctive assessments, and treatment sequencing are determined by the treating physician and are not fully standardized within this pilot study.
Adjunctive assessments, which may include intra-procedural physiologic or pharmacologic evaluations, may be performed at the discretion of the treating physician to inform clinical decision-making but are not required for study participation and are not used as mandatory eligibility criteria.
Participants are followed longitudinally with serial headache diary data and standardized patient-reported outcome measures collected at predefined intervals through 12 months following treatment. The primary endpoint is change in monthly headache days compared with baseline. Secondary endpoints include changes in headache intensity, acute medication use, migraine-related disability, quality of life, and durability of symptom improvement.
Safety is monitored throughout the study through adverse event reporting with independent physician oversight.
Interventions
- Device TEMMA Endovascular Treatment
Endovascular treatment targeting meningeal arterial contributors to migraine performed as part of the TEMMA procedure (Targeted Embolization for Migraine Management) using FDA-cleared devices. Procedural techniques and adjunctive assessments are individualized at the discretion of the treating physician and are not standardized within the study.
Primary outcome measures
- Change in Monthly Headache Days Post-Embolization [Time frame: Baseline to 12 months post-embolization]
Secondary outcome measures (6)
- Change in Headache Intensity [Time frame: Baseline to 12 months post-embolization]
- Change in Acute Medication Use [Time frame: Baseline to 12 months post-embolization.]
- Change in Migraine Disability Assessment (MIDAS) Score [Time frame: Baseline to 3 months (assessed at 1, 3, 6, and 12 months).]
- Change in Migraine-Specific Quality of Life Questionnaire (MSQ v2.1) Score [Time frame: Baseline to 3 months (assessed at 1, 3, 6, and 12 months).]
- Time to Symptom Recurrence Following Lidocaine Testing [Time frame: Up to 4 weeks post-lidocaine testing.]
- Time to Symptom Recurrence Following Embolization [Time frame: Up to 12 months post-embolization.]
Eligibility criteria
Inclusion criteria
- Age 18-60 years
- Diagnosis of migraine (with or without aura)
-≥8 headache days per month
- Failure of ≥2 preventive medication classes
- Ability to complete electronic headache diary and surveys
- Ability to provide informed consent
Exclusion criteria
- Secondary headache disorders
- Prior MMA embolization
- Contraindication to angiography or embolization
- Pregnancy
- Inability to comply with follow-up
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Cortex Neurovascular / TRA Union — Tacoma
Identifiers
NCT: NCT07313800 · EMBRACE-001