External carotid artery stimulation for migraine
Official title: Feasibility and Safety of Endovascular Bipolar Stimulation of the Middle Meningeal Artery for Refractory Headaches (MMA-Stim)
Run by The University of Texas Medical Branch, Galveston · NCT07402954 · Data updated 2026-11-12
This test tries electrical stimulation of the external carotid artery to see if it helps adults with chronic or hard-to-treat migraines during a middle meningeal artery lidocaine infusion.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 100 Years |
| Sex | All |
| Enrollment | 12 (estimated) |
| Sponsor | The University of Texas Medical Branch, Galveston Academic / other |
| Locations | 1 site (Galveston, Texas) |
| Status | Recruiting |
| Started | January 16, 2026 |
| Main results expected | August 2027 |
| Study ends | August 2027 |
| Registry record updated | February 20, 2026 |
| Trial ID | NCT07402954 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with chronic migraine, status migrainosus, or refractory craniofacial pain who are undergoing MMA IA lidocaine infusion and can give informed consent are the ideal candidates.
✕Probably not a fit
People with implanted electronic devices, seizure disorders, intracranial vascular malformations, significant cardiovascular instability, pregnant individuals, children, or those unable to provide informed consent are unlikely to be eligible or to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional protocol applies bipolar electrical stimulation to influence blood flow in the external carotid artery using a Cadwell Cascade 32 PRO device. Participants are adults with chronic migraine, status migrainosus, or craniofacial pain refractory to medical therapy who are already undergoing middle meningeal artery intra-arterial (MMA IA) lidocaine infusion. The primary focus is on safety and feasibility during the infusion while monitoring headache symptoms, hemodynamics, and adverse events. Standard exclusions include implanted electronic devices, seizure disorders, intracranial vascular malformations, significant cardiovascular disease, active infection, pregnancy, and inability to consent.
Why it matters
Potential benefit: If successful, this approach could reduce headache severity or frequency and offer a new option for people with difficult-to-treat migraines.
How similar studies have gone: Other neuromodulation methods for migraine, such as vagus nerve or occipital nerve stimulation, have shown mixed results, and stimulation specifically targeting external carotid artery circulation is novel and largely untested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 * Chronic migraine or status migrainosus, or craniofacial pain refractory to maximal medical therapy who are undergoing MMA IA lidocaine infusion. * Subject has provided informed consent. Exclusion Criteria: * Known allergies to lidocaine * Seizure disorder, history of seizures, or increased seizure susceptibility * Intracranial vascular malformations or dural AVF * Hemodynamic instability, any condition where brief hemodynamic shifts may pose risk * Previous MMA intervention or craniotomy that could result in MMA occlusion * Any implanted electronic device (pacemaker, ICD, DBS, VNS, cochlear implant, spinal cord stimulator) * Significant cardiovascular disease (unstable angina, severe arrhythmias, recent MI) * Severe autonomic dysfunction * Active systemic infection * Vulnerable populations (i.e. pregnant individuals, children, prisoners, individuals lacking decision-making capacity, persons with cognitive impairment, those unable to provide informed consent)
Where it's running
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University of Texas Medical Branch
Galveston, Texas, United States Recruiting
Study contacts
- Principal investigator: Peter Kan, MD,MPH — University of Texas Medial Branch
- Study coordinator: Matias Costa, MD
- Email: mlcosta@utmb.edu
- Phone: 409-772-0330
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.