Middle Meningeal Artery Stimulation
Purpose
This study is testing a new way to help with migraine headaches. Researchers want to see if it's safe and doable to stimulate a blood vessel in the head (called the middle meningeal artery) with microcatheters and microwires. This has never been done before for migraines and is an investigational treatment that is not part of standard migraine treatment. This stimulation would happen just before giving the standard lidocaine treatment, which is already routinely used for migraines. The goal is to see whether this new step could help improve headache outcomes. Two FDA-cleared medical devices will be used, the Cadwell Cascade 32 PRO and the Cadwell Guardian IONM System, to perform the stimulation and monitoring. In this study, the Cascade 32 PRO will be used in a way that is not part of its usual approved purpose (this is called "off-label" use) to gently deliver electrical pulses through a microcatheter. The Cadwell Guardian IONM System will be used in its normal, FDAapproved way for continuous monitoring during stimulation.
Condition
- Migraine
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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Single intervention arm |
Participants will undergo the planned standard-of-care middle meningeal artery (MMA) lidocaine infusion procedure. Before the lidocaine infusion begins, brief investigational electrical stimulation will be delivered using the Cadwell Cascade 32 PRO device through microwires already positioned in the artery. Stimulation will occur on each side for approximately 5 minutes per side. 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 using the Cadwell Guardian IONM System, which is FDA-approved for monitoring use. After stimulation is completed, participants will receive the standard MMA lidocaine infusion (50 mg over 15 minutes) as planned. |
|
Recruiting Locations
Galveston 4692883, Texas 4736286 77555-0133
More Details
- Status
- Recruiting
- Sponsor
- The University of Texas Medical Branch, Galveston
Detailed Description
Once the patient agree to participate in this study and sign the consent form, will be asked to complete the following tests and procedures: - Be prepped to undergo the planned standard of care MMA lidocaine infusion procedure. - Before infusion, the doctors will briefly deliver electrical stimulation using the Cadwell Cascade 32 PRO device through microwires already in the artery. The use of this device for stimulation in the MMA is not approved by the FDA and is investigational. - Stimulation will be given for about 5 minutes on each side. - During stimulation with Cadwell Cascade 32 PRO, your vital signs, neurologic status, and headache severity (on a 0-10 scale) will be recorded. The Cadwell Guardian IONM System device will also be used for continuous monitoring during stimulation. The use of this device for monitoring is approved by the FDA. - After stimulation, you will receive lidocaine infusion into the MMA (50 mg over 15 minutes) as planned.