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Stimulation of External Carotid Artery Circulation

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 100 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether electrical stimulation to change blood flow in an artery called the external carotid artery is safe and practical for controlling headaches. It is for adults with long-term migraines, a migraine that will not stop, or head and face pain that has not improved with full medical treatment.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 or older.
  • You have long-term migraines, a migraine that will not stop, or head and face pain that has not improved with full medical treatment.
  • You are receiving lidocaine, a numbing medicine, through a tube into the middle meningeal artery (MMA), which supplies blood to the brain's covering.
  • You have agreed to join after learning about the study.

Who can't join

  • You have a known allergy to lidocaine.
  • You have a seizure disorder, have had seizures, or have a higher risk of seizures.
  • You have abnormal blood vessels inside your skull or an abnormal connection between arteries and veins in the brain's covering.
  • Your blood pressure or blood flow is unstable, brief changes could be risky, or you have severe problems with the nerves that control automatic body functions.
  • You have had an MMA procedure or surgery to open the skull that could block the MMA.
  • You have any implanted electronic device, such as a pacemaker, heart shock device, nerve or brain stimulator, cochlear hearing implant, or spinal cord stimulator.
  • You have serious heart or blood vessel disease, such as unstable chest pain, a severe abnormal heartbeat, or a recent heart attack, or you have an active infection affecting your body.
  • You are pregnant, a child, or a prisoner; have problems with thinking or memory; cannot make your own decisions; or cannot give informed consent.

Simplified for readability. The official criteria below are what the study team uses.

Official 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)

Study sites (1)

TX