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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 100 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

University of Texas Medical Branch
Galveston, Texas 77555-0133
Contact:
Matias Costa, MD
mlcosta@utmb.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Medical Branch, Galveston

Study Contact

Matias Costa, MD
409-772-0330
mlcosta@utmb.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.