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RECRUITINGINTERVENTIONAL

Stimulation of External Carotid Artery Circulation

Feasibility and Safety of Endovascular Bipolar Stimulation of the Middle Meningeal Artery for Refractory Headaches (MMA-Stim)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form. Who Should NOT Join This Trial: - 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 willing to sign a consent form) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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)

Treatments Being Tested

DEVICE

Cadwell Cascade 32 PRO

Cascade 32 PRO will be to gently deliver electrical pulses.

Locations (1)

University of Texas Medical Branch
Galveston, Texas, United States