EMBRACE Study: Enduring Migraine Benefit From Responsive Artery Coil Embolization
Part of paid clinical trials in Tacoma, Washington.
- Sponsor
- Cortex Neurovascular
- Study ID
- NCT07313800
- Status
- Not Yet Recruiting
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Conditions
- Chronic Migraine
- Migraine Disorders
- Refractory Migraine
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 60 Years
- Healthy Volunteers
- Not accepted
Interventions
- TEMMA Endovascular Treatment — DEVICEEndovascular 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.
Study Details
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).
Key Dates
- Start date
- Mar 1, 2026
- Status verified
- Feb 2026
- Primary completion
- Mar 1, 2027
- Completion
- Mar 1, 2028
Study Design
- Enrollment
- 25 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: TEMMA Procedure (Targeted Embolization for Migraine Management)Participants with refractory migraine undergo the TEMMA procedure (Targeted Embolization for Migraine Management), an endovascular treatment strategy addressing meningeal arterial contributors to migraine. Treatment is performed using FDA-cleared devices per institutional clinical practice. Procedural details and adjunctive assessments are individualized and not dictated by the study protocol. Outcomes are evaluated using within-subject comparison to baseline.
Primary Outcome Measure
Change in Monthly Headache Days Post-Embolization [ Time Frame: Baseline to 12 months post-embolization ]
Central Contacts
- Dennis Wang, MD253-761-4200
- Brian Kott, MD253-761-4200
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Cortex Neurovascular / TRA Union | Tacoma | Washington | 98405 |
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