Feasibility and Safety of Endovascular Bipolar Stimulation of the Middle Meningeal Artery for Refractory Headaches (MMA-Stim)
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This study is testing a new approach to help people with migraine headaches. Researchers want to find out if using electrical stimulation to affect blood flow in the external carotid artery is safe and practical for helping control headaches. The goal of the study is to determine whether this approach could improve headache symptoms and overall outcomes for people with migraines.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:
• 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.
Locations
United States
Texas
University of Texas Medical Branch
RECRUITING
Galveston
Contact Information
Primary
Matias Costa, MD
mlcosta@utmb.edu
409-772-0330
Backup
Patrick Karas, MD
pjkaras@utmb.edu
409-772-0330
Time Frame
Start Date: 2026-01-16
Estimated Completion Date: 2027-08
Participants
Target number of participants: 12
Treatments
Experimental: Single intervention arm
Participants will undergo the planned external carotid artery circulation procedure. Before the lidocaine infusion begins, bipolar stimulation will be delivered through the external carotid artery circulation.~During stimulation, clinicians will record vital signs, neurologic status, and headache severity using a 0-10 scale. Continuous intra-procedural monitoring will also be performed.~After bipolar stimulation is completed, participants will receive lidocaine infusion as planned.
Sponsors
Leads: The University of Texas Medical Branch, Galveston