EMBRACE Study: Enduring Migraine Benefit From Responsive Artery Coil Embolization

NCT ID: NCT07313800

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-01
• Study Completion Date: 2028-03-01

Brief Summary

This single-site, open-label pilot study evaluates bilateral middle meningeal artery (MMA) coil embolization using FDA-cleared devices in adults aged 18-60 with refractory migraine (≥8 headache days per month despite failure of at least two preventive medication classes).

The embolization approach used in this study is referred to as the TEMMA procedure (Targeted Embolization for Migraine MAnagement), which reflects a standardized endovascular technique used in clinical practice.

Participants first undergo bilateral MMA lidocaine testing during diagnostic angiography to assess short-term symptom response. Those demonstrating a positive response (≥50% reduction in headache intensity or frequency) proceed to bilateral MMA coil embolization. The study assesses safety, feasibility, and durability of migraine relief over 12 months using headache days, pain intensity, acute medication use, migraine-related disability (MIDAS), and quality of life (MSQ v2.1).

Detailed Description

This is an investigator-initiated, prospective, single-site, open-label pilot study (EMBRACE) designed to evaluate the safety, feasibility, and potential durability of bilateral middle meningeal artery (MMA) coil embolization in patients with refractory migraine.

The embolization approach evaluated in this study is referred to as the TEMMA protocol (Targeted Embolization for Migraine MAnagement), which represents a standardized endovascular technique using FDA-cleared embolization devices and routine neurointerventional methods.

Participants undergo a 4-week baseline observation period with daily SMS-based headache diary collection, including headache presence, pain intensity (0-10), and acute medication use, as well as baseline MIDAS and MSQ v2.1 assessments. Eligible patients then undergo bilateral MMA lidocaine testing via diagnostic cerebral angiography with intra-arterial lidocaine administration. A positive response is defined as either ≥50% reduction in headache pain intensity if present at the time of the procedure or ≥50% reduction in average weekly headache days or intensity over the subsequent 14 days.

Responders proceed to a 4-week post-lidocaine observation period followed by bilateral MMA coil embolization performed per standard clinical practice using FDA-cleared detachable coils. Follow-up includes headache diary data collected at regular intervals and MIDAS/MSQ v2.1 assessments at 1, 3, 6, and 12 months post-embolization.

The primary endpoint is change in monthly headache days following embolization compared with baseline. Secondary endpoints include headache intensity, acute medication use, migraine-related disability, quality of life, and time to symptom recurrence following lidocaine testing and embolization. Safety is monitored through adverse event reporting with independent physician oversight.

Conditions

Migraine Disorders; Refractory Migraine; Chronic Migraine

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bilateral MMA Coil Embolization

Participants with refractory migraine who demonstrate a positive response (≥50% reduction in headache intensity or frequency) to bilateral middle meningeal artery lidocaine testing proceed to bilateral middle meningeal artery coil embolization using FDA-cleared detachable coils. Outcomes are assessed via within-subject comparison to baseline.

Group Type: EXPERIMENTAL

Bilateral Middle Meningeal Artery Lidocaine Testing

Intervention Type: PROCEDURE

Diagnostic cerebral angiography with intra-arterial administration of lidocaine to bilateral middle meningeal arteries to assess short-term migraine response and enrich the cohort (positive response required for progression to embolization).

Bilateral Middle Meningeal Artery Coil Embolization

Intervention Type: DEVICE

Endovascular embolization of bilateral middle meningeal arteries using FDA-cleared detachable coils, performed in lidocaine responders per standard clinical practice.

Interventions

Bilateral Middle Meningeal Artery Lidocaine Testing

Diagnostic cerebral angiography with intra-arterial administration of lidocaine to bilateral middle meningeal arteries to assess short-term migraine response and enrich the cohort (positive response required for progression to embolization).

Intervention Type: PROCEDURE

Bilateral Middle Meningeal Artery Coil Embolization

Endovascular embolization of bilateral middle meningeal arteries using FDA-cleared detachable coils, performed in lidocaine responders per standard clinical practice.

Intervention Type: DEVICE

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
• Demonstrated clinical response to bilateral MMA lidocaine testing
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cortex Neurovascular

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dennis Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Cortex Neurovascular

Locations

Cortex Neurovascular / TRA Union

Tacoma, Washington, United States

Countries

United States

Central Contacts

Dennis Wang, MD

Role: CONTACT

dwang@cortexmgmt.com

253-761-4200

Brian Kott, MD

Role: CONTACT

bkott@tranow.com

253-761-4200

Facility Contacts

Dennis Wang, MD

Role: primary

dwang@cortexmgmt.com

253-761-4200

Other Identifiers

EMBRACE-001

Identifier Type: -

Identifier Source: org_study_id