MigraineMMA-StimNCT07402954
Stimulation of External Carotid Artery Circulation
A study testing Cadwell Cascade 32 PRO in people with Migraine, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Migraine
- What is being tested?
- Cadwell Cascade 32 PRO
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2026to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Texas Medical Branch
Galveston, Texas, 77555-0133
Matias Costa, MD, mlcosta@utmb.edu
About this study
Official title: 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.
- Conditions
- Migraine
- Being tested
- Cadwell Cascade 32 PRO
- Keywords
- Migraine, External carotid artery circulation, Bipolar Stimulation
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cadwell Cascade 32 PRODevice
Cascade 32 PRO will be to gently deliver electrical pulses.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Cadwell Cascade 32 PRO |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: 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)
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."
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Perioperative/Periprocedural, and at follow-up at 7 days, 30 days, and 90 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start16 Jan 2026
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Kan, MD,MPH, Principal investigator, University of Texas Medial Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07402954
- Sponsor's protocol ID
- 25-0282
- Acronym
- MMA-Stim
- Status last verified
- Feb 2026
- First submitted
- 26 Jan 2026
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Safety of Endovascular Bipolar Stimulation of the Middle Meningeal Artery for Refractory Headaches (MMA-Stim)
- ClinicalTrials.gov ID
- NCT07402954
- Acronym / sponsor ID
- MMA-Stim / 25-0282
- Conditions
- Migraine
- Keywords
- Migraine, External carotid artery circulation, Bipolar Stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 16 Jan 2026 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 11 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single intervention arm | Experimental | Device: Cadwell Cascade 32 PROParticipants 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cadwell Cascade 32 PROCascade 32 PRO will be to gently deliver electrical pulses. | Device | Single intervention arm |
Primary outcome
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.
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.
4 secondary outcomes
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.
Physiologic Responses During Stimulation
Time frame: Perioperative/Periprocedural
Patient-Reported Qualitative Outcomes
Time frame: At 24 hours, 7 days, 30 days, and 90 days after the procedure.
Number of Adverse Events
Time frame: Perioperative/Periprocedural, and at follow-up at 7 days, 30 days, and 90 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter Kan, MD,MPH principal investigator
University of Texas Medial Branch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cadwell Cascade 32 PRO in people with Migraine, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matias Costa, MD (409-772-0330, mlcosta@utmb.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.