An interventional study of TEMMA Endovascular Treatment in Migraine Disorders, Refractory Migraine and Chronic Migraine, sponsored by Cortex Neurovascular. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-02-04.
Sponsored by Cortex Neurovascular · Not applicable, Interventional, and Treatment
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).
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.
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's planned enrollment of 25 is below the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Cortex Neurovascular is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Diagnosis of migraine (with or without aura)
-≥8 headache days per month
Exclusion Criteria:
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.
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
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
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.
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).
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).
Time to Symptom Recurrence Following Lidocaine Testing
Duration of symptom improvement (time to return to baseline headache frequency/intensity) after bilateral MMA lidocaine testing.
Time frame: 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.
Time frame: Up to 12 months post-embolization.
Plan to share: No
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This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Cortex Neurovascular