Migraine DisordersEMBRACENCT07313800
EMBRACE Study: Enduring Migraine Benefit From Responsive Artery Coil Embolization
A study testing TEMMA Endovascular Treatment in people with Migraine Disorders and Refractory Migraine, run by Cortex Neurovascular at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Migraine Disorders, Refractory Migraine, Chronic Migraine
- What is being tested?
- TEMMA Endovascular Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2028to 1 Mar 2032
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Secondary headache disorders
- Prior MMA embolization
- Contraindication to angiography or embolization
- Pregnancy
- Inability to comply with follow-up
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Cortex Neurovascular / TRA Union
Tacoma, Washington, 98405
Dennis Wang, MD, 253-761-4200, dwang@cortexmgmt.com
About this study
Official title: 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).
Read the 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.
- Conditions
- Migraine Disorders, Refractory Migraine, Chronic Migraine
- Being tested
- TEMMA Endovascular Treatment
- 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
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEMMA Endovascular TreatmentDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: TEMMA Endovascular Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 12 months post-embolization
Secondary outcomes (6)
Change in Headache Intensity
Change from baseline in average headache pain intensity (0-10 scale), assessed via SMS-based headache diary.
Measured: Baseline to 12 months post-embolization
Change in Acute Medication Use
Change from baseline in the number of days with acute migraine medication use per month.
Measured: Baseline to 12 months post-embolization.
Change in Migraine Disability Assessment (MIDAS) Score
Change from baseline in MIDAS score, a validated measure of migraine-related disability.
Measured: Baseline to 3 months (assessed at 1, 3, 6, and 12 months).
Change in Migraine-Specific Quality of Life Questionnaire (MSQ v2.1) Score
Change from baseline in MSQ v2.1 score, a validated measure of migraine-specific quality of life.
Measured: Baseline to 3 months (assessed at 1, 3, 6, and 12 months).
Time to Symptom Recurrence Following Lidocaine Testing
Duration of symptom improvement (time to return to baseline headache frequency/intensity) after bilateral MMA lidocaine testing.
Measured: Up to 4 weeks post-lidocaine testing.
Time to Symptom Recurrence Following Embolization
Duration of symptom improvement (time to return to baseline headache frequency/intensity) after bilateral MMA coil embolization.
Measured: Up to 12 months post-embolization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start1 Mar 2028 (estimated)
- Primary completion1 Mar 2030 (estimated)
- Study completion1 Mar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cortex Neurovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dennis Wang, MD, Principal investigator, Cortex Neurovascular
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07313800
- Sponsor's protocol ID
- EMBRACE-001
- Acronym
- EMBRACE
- Status last verified
- Oct 2026
- First submitted
- 30 Dec 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No