Stimulation of External Carotid Artery Circulation (MMA-Stim)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Migraine
• Intervention / Treatment: Device: Cadwell Cascade 32 PRO

Detailed Description

Once the patient agree to participate in this study and sign the consent form, will be asked to complete the following tests and procedures:

• Be prepped to undergo the planned standard of care MMA lidocaine infusion procedure.
• Before infusion, the doctors will briefly deliver electrical stimulation using the Cadwell Cascade 32 PRO device through microwires already in the artery. The use of this device for stimulation in the MMA is not approved by the FDA and is investigational.
• Stimulation will be given for about 5 minutes on each side.
• During stimulation with Cadwell Cascade 32 PRO, your vital signs, neurologic status, and headache severity (on a 0-10 scale) will be recorded. The Cadwell Guardian IONM System device will also be used for continuous monitoring during stimulation. The use of this device for monitoring is approved by the FDA.
• After stimulation, you will receive lidocaine infusion into the MMA (50 mg over 15 minutes) as planned.

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Matias Costa, MD; Phone Number: 409-772-0330; Email: mlcosta@utmb.edu
• Study Contact Backup: Name: Patrick Karas, MD; Phone Number: 409-772-0330; Email: pjkaras@utmb.edu

Study Locations

• United States
  • Texas
    • Galveston, Texas, United States, 77555-0133
      • Recruiting
      • University of Texas Medical Branch
      • Contact: Matias Costa, MD; Email: mlcosta@utmb.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Single intervention arm; Participants will undergo the planned external carotid artery circulation procedure. Before the lidocaine infusion begins, bipolar stimulation will be delivered through the external carotid artery circulation. During stimulation, clinicians will record vital signs, neurologic status, and headache severity using a 0-10 scale. Continuous intra-procedural monitoring will also be performed. After bipolar stimulation is completed, participants will receive lidocaine infusion as planned.

Device: Cadwell Cascade 32 PRO; Cascade 32 PRO will be to gently deliver electrical pulses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of Bipolar external carotid artery circulation Stimulation	Safety will be evaluated based on the ability to complete the stimulation procedure without technical failure, serious complications, or procedure-related neurological deficits.	Measured Perioperative/Periprocedural and through the immediate post-procedural period (up to 24 hours).
Feasibility of Bipolar external carotid artery circulation Stimulation	Feasibility will be demonstrated if stimulation can be successfully initiated and completed using the intended bipolar approach.	Measured Perioperative/Periprocedural and through the immediate post-procedural period (up to 24 hours).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Headache Severity Measured by the Visual Analog Scale (VAS)	Headache severity will be assessed using the Visual Analog Scale (VAS), a validated 0-10 cm scale in which participants indicate headache intensity by marking a point along a continuous line representing "no pain" to "worst pain."	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	Physiologic responses, including heart rate, blood pressure, respiratory rate, and oxygen saturation, will be recorded during active stimulation to assess acute physiologic effects.	Perioperative/Periprocedural
Patient-Reported Qualitative Outcomes	Patient-reported qualitative outcomes includes perceived headache relief, tolerability of the intervention, and the presence of any new or worsening symptoms.	At 24 hours, 7 days, 30 days, and 90 days after the procedure.
Number of Adverse Events	Adverse events and serious adverse events including seizures, vascular complications, and signs of lidocaine toxicity.	Perioperative/Periprocedural, and at follow-up at 7 days, 30 days, and 90 days.

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston
• Investigators: Principal Investigator: Peter Kan, MD,MPH, University of Texas Medial Branch

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: January 26, 2026
• First Submitted That Met QC Criteria: February 3, 2026
• First Posted (Actual): February 11, 2026

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 18, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Migraine; External carotid artery circulation; Bipolar Stimulation
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: 25-0282

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes