Middle Meningeal Artery Stimulation for Migraine
(MMA-Stim Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method to treat migraine headaches by stimulating the middle meningeal artery, a blood vessel in the head. Researchers aim to determine if gentle electrical pulses before the usual lidocaine treatment can improve headache symptoms. The trial tests this new approach for safety and effectiveness. It suits individuals with migraines or severe headaches unresponsive to typical treatments and who already receive lidocaine for relief. As an unphased trial, this study allows participants to contribute to innovative research that could lead to new migraine treatment options.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this method is safe for migraine treatment?
Research has shown that a similar procedure, middle meningeal artery embolization, is generally safe and well-tolerated. Many patients in studies reported fewer headaches, with some experiencing complete relief. This suggests that working with the middle meningeal artery, as in the procedure being tested, could be safe.
In this trial, two FDA-approved devices will be used. The Cadwell Cascade 32 PRO device will deliver gentle electrical pulses, though in a manner not typically approved. The Cadwell Guardian IONM System will monitor vital signs and nerve functions during the procedure, ensuring safety by closely observing the body's responses.
While this specific technique for treating migraines is new, the safety record of similar procedures suggests it might be well-tolerated. Any new treatment can have risks, so discussing participation with a doctor is important if considering joining the trial.12345Why are researchers excited about this trial?
Middle Meningeal Artery Stimulation is unique because it targets the middle meningeal artery directly with electrical stimulation before the standard lidocaine infusion. This approach is different from typical migraine treatments like oral medications or injections, which primarily focus on blocking pain pathways or reducing inflammation. By using microwires to deliver electrical stimulation directly to the artery, this method could potentially provide faster relief and improve the effectiveness of subsequent lidocaine treatment. Researchers are excited because this novel mechanism could offer a new, more precise way to manage migraines, potentially leading to better outcomes for patients.
What evidence suggests that middle meningeal artery stimulation might be an effective treatment for migraines?
Research shows that stimulating a specific artery in the head might help with migraines. One study found that 89% of patients experienced improved headaches, and 78% achieved complete relief after a related procedure. This trial will investigate Middle Meningeal Artery Stimulation, which involves stimulating the protective layer around the brain. This approach can both cause and relieve migraine pain, suggesting that focusing on this area could be effective. Early studies have also found that similar treatments improved chronic migraines. Although this method is new, these findings offer hope for its potential success.12346
Who Is on the Research Team?
Peter Kan, MD,MPH
Principal Investigator
University of Texas Medial Branch
Are You a Good Fit for This Trial?
This trial is for adults over 18 with chronic migraines or severe facial pain that hasn't improved with standard treatments. Participants will already be getting a lidocaine infusion, which is a common migraine treatment. They must understand the study and agree to participate.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo investigational electrical stimulation of the middle meningeal artery followed by standard lidocaine infusion
Immediate Post-procedural Monitoring
Participants are monitored for safety and feasibility immediately after the procedure
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Middle Meningeal Artery Stimulation
Trial Overview
Researchers are testing if stimulating a head blood vessel (middle meningeal artery) can improve migraine treatment outcomes. This involves using two devices: Cadwell Cascade 32 PRO (off-label use) and Cadwell Guardian IONM System (FDA-approved use), before standard lidocaine therapy.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
The University of Texas Medical Branch, Galveston
Lead Sponsor
Citations
Middle meningeal artery embolization in migraine - PMC - NIH
The study reported promising outcomes, with 89% of patients experiencing improved headaches and 78% achieving complete resolution. Similarly, a ...
Middle meningeal artery embolization for migraine: A review
[32,51] Data from awake craniotomies have established that mechanical and electrical stimulation of the dura can induce pain in the sensory ...
E-250 Feasibility of middle meningeal artery embolization ...
Refractory CM affects approximately 5% of migraine patients. Preliminary studies have demonstrated improvement in CM among patients who underwent middle ...
Middle meningeal artery embolization for migraine: A review
There is some evidence that embolization of the MMA is emerging as a promising treatment for chronic headaches. A retrospective study on ...
NCT07402954 | Middle Meningeal Artery Stimulation
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 ...
Comparative effectiveness of standalone middle meningeal ...
The primary outcome was reintervention due to hematoma recurrence. Secondary outcomes included the hospital length of stay (LOS), new neurological deficits, and ...
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