NCT07402954

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
15mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress20%
Jan 2026Aug 2027

Study Start

First participant enrolled

January 16, 2026

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 11, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

1.5 years

First QC Date

January 26, 2026

Last Update Submit

February 18, 2026

Conditions

Migraine

Keywords

MigraineExternal carotid artery circulationBipolar Stimulation

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Headache Severity Measured by the Visual Analog Scale (VAS)

    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

    Perioperative/Periprocedural

  • Patient-Reported Qualitative Outcomes

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

  • Number of Adverse Events

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

Study Arms (1)

Single intervention arm

EXPERIMENTAL

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

Interventions

Cadwell Cascade 32 PRODEVICE

Cascade 32 PRO will be to gently deliver electrical pulses.

Single intervention arm

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555-0133, United States

RECRUITING

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Peter Kan, MD,MPH

    University of Texas Medial Branch

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Matias Costa, MD

CONTACT

409-772-0330mlcosta@utmb.edu

Patrick Karas, MD

CONTACT

409-772-0330pjkaras@utmb.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2026

First Posted

February 11, 2026

Study Start

January 16, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

February 20, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)