Health TrialsbyHealthPanel

EMBRACE Study: Enduring Migraine Benefit From Responsive Artery Coil Embolization

ConditionsMigraine DisordersRefractory MigraineChronic Migraine
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorCortex Neurovascular

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-60 years

Diagnosis of migraine (with or without aura)

Failure of ≥2 preventive medication classes

Ability to complete electronic headache diary and surveys

Disqualifiers

Secondary headache disorders

Prior MMA embolization

Contraindication to angiography or embolization

Pregnancy

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: TEMMA Procedure (Targeted Embolization for Migraine Management)Experimental treatment 1 intervention

Trial outcomes

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.

Time frame
Baseline to 12 months post-embolization

Secondary outcomes

1

Change in Headache Intensity

Change from baseline in average headache pain intensity (0-10 scale), assessed via SMS-based headache diary.

Time frame
Baseline to 12 months post-embolization
2

Change in Acute Medication Use

Change from baseline in the number of days with acute migraine medication use per month.

Time frame
Baseline to 12 months post-embolization.
3

Change in Migraine Disability Assessment (MIDAS) Score

Change from baseline in MIDAS score, a validated measure of migraine-related disability.

Time frame
Baseline to 3 months (assessed at 1, 3, 6, and 12 months).
4

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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cortex Neurovascular

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: