EMBRACE Study: Enduring Migraine Benefit From Responsive Artery Coil Embolization (EMBRACE)

February 2, 2026 updated by: Cortex Neurovascular

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

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Washington
      • Tacoma, Washington, United States, 98405
        • Cortex Neurovascular / TRA Union
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Monthly Headache Days Post-Embolization
Time Frame: Baseline to 12 months 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Headache Intensity
Time Frame: Baseline to 12 months post-embolization
Change from baseline in average headache pain intensity (0-10 scale), assessed via SMS-based headache diary.
Baseline to 12 months post-embolization
Change in Acute Medication Use
Time Frame: Baseline to 12 months post-embolization.
Change from baseline in the number of days with acute migraine medication use per month.
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 from baseline in MIDAS score, a validated measure of migraine-related disability.
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).
Change from baseline in MSQ v2.1 score, a validated measure of migraine-specific quality of life.
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.
Duration of symptom improvement (time to return to baseline headache frequency/intensity) after bilateral MMA lidocaine testing.
Up to 4 weeks post-lidocaine testing.
Time to Symptom Recurrence Following Embolization
Time Frame: Up to 12 months post-embolization.
Duration of symptom improvement (time to return to baseline headache frequency/intensity) after bilateral MMA coil embolization.
Up to 12 months post-embolization.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cortex Neurovascular

Investigators

  • Principal Investigator: Dennis Wang, MD, Cortex Neurovascular

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

December 30, 2025

First Submitted That Met QC Criteria

December 30, 2025

First Posted (Actual)

January 2, 2026

Study Record Updates

Last Update Posted (Actual)

February 4, 2026

Last Update Submitted That Met QC Criteria

February 2, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMBRACE-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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