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NCT Number: NCT07402954

Stimulation of External Carotid Artery Circulation

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.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas Medical Branch

Galveston, Texas, 77555-0133, United States

Location status: Recruiting

Location contact

Matias Costa, MD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cadwell Cascade 32 PRO

Device

Cascade 32 PRO will be to gently deliver electrical pulses.

Primary outcomes

  1. Safety of Bipolar external carotid artery circulation Stimulation

    Time frame: Measured Perioperative/Periprocedural and through the immediate post-procedural period (up to 24 hours).

    Safety will be evaluated based on the ability to complete the stimulation procedure without technical failure, serious complications, or procedure-related neurological deficits.

  2. Feasibility of Bipolar external carotid artery circulation Stimulation

    Time frame: Measured Perioperative/Periprocedural and through the immediate post-procedural period (up to 24 hours).

    Feasibility will be demonstrated if stimulation can be successfully initiated and completed using the intended bipolar approach.

Secondary outcomes

  1. 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.

    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."

  2. Physiologic Responses During Stimulation

    Time frame: Perioperative/Periprocedural

    Physiologic responses, including heart rate, blood pressure, respiratory rate, and oxygen saturation, will be recorded during active stimulation to assess acute physiologic effects.

  3. Patient-Reported Qualitative Outcomes

    Time frame: At 24 hours, 7 days, 30 days, and 90 days after the procedure.

    Patient-reported qualitative outcomes includes perceived headache relief, tolerability of the intervention, and the presence of any new or worsening symptoms.

  4. Number of Adverse Events

    Time frame: Perioperative/Periprocedural, and at follow-up at 7 days, 30 days, and 90 days.

    Adverse events and serious adverse events including seizures, vascular complications, and signs of lidocaine toxicity.

Study contacts

Contact information is provided by the study sponsor or research team.

Matias Costa, MD

CONTACT

[email protected]

409-772-0330

Patrick Karas, MD

CONTACT

[email protected]

409-772-0330

Sponsors and collaborators

Lead sponsor

The University of Texas Medical Branch, Galveston

Other

Registry information

Official study title

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

Acronym: MMA-Stim

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 11, 2026
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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