Recruiting

Electrical Stimulation

Sponsor:

The University of Texas Medical Branch, Galveston

Code:

NCT07402954

Conditions

Migraine

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Cadwell Cascade 32 PRO

Study Details

Brief summary:

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.

Conditions

Migraine

Study ID

NCT07402954

Start date

Jan 16, 2026

Status verified date

Feb, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Cadwell Cascade 32 PRO

Cascade 32 PRO will be to gently deliver electrical pulses.

Primary outcome measure

  • 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). ]

Central Contacts and Locations

Central contacts

Matias Costa, MD

409-772-0330mlcosta@utmb.edu

Patrick Karas, MD

409-772-0330pjkaras@utmb.edu

Locations

University of Texas Medical Branch

Recruiting

Galveston, Texas, United States, 77555-0133

Contacts

Matias Costa, MD

mlcosta@utmb.edu

More Information

Sponsor

The University of Texas Medical Branch, Galveston

Last update posted

Feb 20, 2026

Last verified

Feb, 2026

Keywords

  • Migraine
  • External carotid artery circulation
  • Bipolar Stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Medical Branch, Galveston on 2026-02-20.