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

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • TEMMA Endovascular Treatment — DEVICE
    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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
Cortex Neurovascular / TRA UnionTacomaWashington98405
Dennis Wang, MD
253-761-4200

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