Stimulation of External Carotid Artery Circulation
Recruiting · NCT07402954 · Interventional (participants receive a specific treatment) · Lead sponsor: The University of Texas Medical Branch, Galveston
View the official record on ClinicalTrials.gov →Interventions studied
Cadwell Cascade 32 PRO
What this trial is about
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 can take part
Age range
18 Years to 100 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed across 1 US state.
- University of Texas Medical Branch - Galveston, Texas, United States