NCT07402954NARecruiting
Stimulation of External Carotid Artery Circulation
The University of Texas Medical Branch, Galveston
Start Date
1/16/2026
Completion Date
8/1/2027
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 Criteria
Age Range: 18 years to 100 years
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)
Interventions
DEVICE
Cadwell Cascade 32 PRO
Conditions
Migraine
Locations
University of Texas Medical Branch
Galveston, Texas 77555-0133
United States