Stimulation of External Carotid Artery Circulation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cadwell Cascade 32 PRO.
- Who it may be relevant to
- Registry conditions: Migraine. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Feasibility and Safety of Endovascular Bipolar Stimulation of the Middle Meningeal Artery for Refractory Headaches (MMA-Stim)
Overview
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.
Interventions
- Device Cadwell Cascade 32 PRO
Cascade 32 PRO will be to gently deliver electrical pulses.
Primary outcome measures
- Safety of Bipolar external carotid artery circulation Stimulation [Time frame: Measured Perioperative/Periprocedural and through the immediate post-procedural period (up to 24 hours).]
- Feasibility of Bipolar external carotid artery circulation Stimulation [Time frame: Measured Perioperative/Periprocedural and through the immediate post-procedural period (up to 24 hours).]
Secondary outcome measures (4)
- Headache Severity Measured by the Visual Analog Scale (VAS) [Time frame: At baseline, Perioperative/Periprocedural, immediately post-procedure, and at following post-op times 2-4 hours, 7 days, 30 days, and 90 days.]
- Physiologic Responses During Stimulation [Time frame: Perioperative/Periprocedural]
- Patient-Reported Qualitative Outcomes [Time frame: At 24 hours, 7 days, 30 days, and 90 days after the procedure.]
- Number of Adverse Events [Time frame: Perioperative/Periprocedural, and at follow-up at 7 days, 30 days, and 90 days.]
Eligibility 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Texas Medical Branch — Galveston
Identifiers
NCT: NCT07402954 · 25-0282