EMBRACE Study: Enduring Migraine Benefit From Responsive Artery Coil Embolization

NCT07313800 | Not Yet Recruiting FDA Device

• 1 other identifier: EMBRACE-001
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Migraine Disorders; Refractory Migraine; Chronic Migraine

Keywords

Middle Meningeal Artery Embolization; MMA Embolization; Refractory Migraine; Coil Embolization; Neurovascular Intervention; Migraine Prevention; TEMMA; TEMMA procedure; TEMMA protocol; Targeted Embolization for Migraine Management

Outcome Measures

Primary Outcomes (1)

• Change in Monthly Headache Days Post-Embolization

  Change from baseline in the number of headache days per month following bilateral middle meningeal artery coil embolization, assessed via SMS-based headache diary.

  Baseline to 12 months post-embolization

Secondary Outcomes (6)

• Change in Headache Intensity

  Baseline to 12 months post-embolization

• Change in Acute Medication Use

  Baseline to 12 months post-embolization.

• Change in Migraine Disability Assessment (MIDAS) Score

  Baseline to 3 months (assessed at 1, 3, 6, and 12 months).

• Change in Migraine-Specific Quality of Life Questionnaire (MSQ v2.1) Score

  Baseline to 3 months (assessed at 1, 3, 6, and 12 months).

• Time to Symptom Recurrence Following Lidocaine Testing

  Up to 4 weeks post-lidocaine testing.

Study Arms (1)

TEMMA Procedure (Targeted Embolization for Migraine Management)

EXPERIMENTAL

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.

Device: TEMMA Endovascular Treatment

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.

TEMMA Procedure (Targeted Embolization for Migraine Management)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Secondary headache disorders
• Prior MMA embolization
• Contraindication to angiography or embolization
• Pregnancy
• Inability to comply with follow-up

Sponsors & Collaborators

• Cortex Neurovascular: lead

Study Sites (1)

Cortex Neurovascular / TRA Union

Tacoma, Washington, 98405, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Dennis Wang, MD

  Cortex Neurovascular

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dennis Wang, MD

CONTACT

253-761-4200; dwang@cortexmgmt.com

Brian Kott, MD

CONTACT

253-761-4200; bkott@tranow.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-arm, open-label pilot study evaluating outcomes following the TEMMA procedure (Targeted Embolization for Migraine Management). All enrolled participants undergo endovascular treatment targeting meningeal arterial contributors to migraine as part of the TEMMA clinical program. Adjunctive intra-procedural assessments may be performed at the discretion of the treating physician but are not required for participation and are not used as mandatory eligibility criteria. Outcomes are assessed within-subject and compared against baseline.

Study Record Dates

• First Submitted: December 30, 2025
• First Posted: January 2, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)