Middle Meningeal Artery Stimulation

The University of Texas Medical Branch, Galveston12 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Safety of Bipolar Middle Meningeal Artery (MMA) Stimulation

Safety will be evaluated based on the ability to complete the stimulation procedure without technical failure, serious complications, or procedure-related neurological deficits.

Time frame: Measured Perioperative/Periprocedural and through the immediate post-procedural period (up to 24 hours).

Feasibility of Bipolar Middle Meningeal Artery (MMA) Stimulation

Feasibility will be demonstrated if stimulation can be successfully initiated and completed using the intended bipolar approach.

Time frame: Measured Perioperative/Periprocedural and through the immediate post-procedural period (up to 24 hours).

Secondary Outcomes

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."

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

Physiologic responses, including heart rate, blood pressure, respiratory rate, and oxygen saturation, will be recorded during active stimulation to assess acute physiologic effects.

Time frame: 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.

Time frame: 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.

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

Middle Meningeal Artery Stimulation

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts