Innovations in Migraine Care Under Study at UH

UH Clinical Update | September 2026

One in four American households has someone who suffers from migraines. Despite that sizeable number, there are just 800 certified headache physicians in the U.S. to provide treatment. 

At UH, the departments of Neurology and Pain Management, as well as the UH Primary Care Institute and UH Connor Whole Health, are working collaboratively to address this mismatch, testing more and possibly better options for treating migraine. 

One option is a clinical trial of a BOTOX alternative. The MINT-C trial of the medication Xeomin, led at UH by neurologists Deborah Reed, MD, Naveen George, DO, and Davina Patel, CRS- 2, is assessing its effectiveness in preventing chronic migraine. Experts define this as 15 or more episodes per month for at least three months, with eight of those episodes meeting typical migraine symptoms. The MINT-C trial, which just closed enrollment, was open to people at least age 18, who’ve been diagnosed with chronic migraines and whose migraines started before age 50. Enrollment in the trial lasts about a year, with 14 study visits – eight of which are telehealth visits and four where the patient receives a treatment or placebo. 

A related trial is MINT-E, also evaluating the effectiveness of Xeomin, but in people experiencing episodic migraines between zero and 14 days per month. Study inclusion criteria for age and age at migraine onset are the same as for the MINT-C trial. 

Another option for UH patients with migraine is a collaboration between the departments of Pain Management and Neurology – the RELIEV-CM2 trial of an implantable neurostimulator. The device is implanted in the scalp, with a battery worn behind the ear. Samer Narouze, MD, PhD, Division Chief of Pain Management at UH Cleveland Medical Center, is national co-principal investigator on the study, which just reached its enrollment goal. Salim Hayek, MD, Michael Staudt, MD, George R. and Constance P. Lincoln Chair in Brain Health, University Hospitals, and Deborah Reed, MD, are co-principal investigators at UH. 

"As the national co-principal investigators for RELIEV-CM2, I’ve seen firsthand how many people with chronic migraine remain inadequately served despite the real advances of recent years," Dr. Narouze says. "Completing pivotal enrollment in a rigorous, randomized study of this design is a significant step, and the engagement we saw across sites reflects how much need remains for new, evidence-based options. We look forward to the data, and to what a purpose-built approach could add to the care of patients who have exhausted much of what is currently available." 

In addition to clinical trials, which advance the science of migraine therapeutics, we at UH are studying healthcare delivery models. “Our advanced therapeutics are not good if we cannot reach the patients who need them,” Dr. Reed says. To reach more patients who need care, the team is pioneering EConsults, patient group appointments and specialized scholarly education /collaboration with primary care colleagues.

Dr. Reed is collaborating with Stacey Gardner-Buckshaw, PhD, from NEOMED, and program coordinator Kara Ring, from UH Rainbow Babies & Children’s, who’ve had success using what’s known as the Project ECHO TM (Extension for Community Healthcare Outcomes) model. This “hub and spoke” framework links specialists with local clinicians using videoconferencing to share knowledge and manage complex health conditions. 

“Rainbow developed a project in the ECHO model, a training model to improve outcomes in subspecialties like pediatric neurology,” Dr. Reed says. “We teach primary care doctors about a certain disease state area so their patients can receive quality care with their primary care doctors and don't have to travel or wait to see sub-specialists. This is especially important for rural or underserved areas or sub-specialties, where it's difficult to travel or get an appointment.”

“Dr Gardner-Buckshaw from NEOMED has led the way in the research in this teaching/collaborating model, and Rainbow has experience in the delivery of these training models,” she adds. “We’re combining their expertise to assess treatment of headache and how we might better deliver care -- how we might see more patients with fewer headache specialist providers. With only 800 headache specialists in the United States, it's a chronically underserved area.” 

Other initiatives in the works include increased use of EConsults as triage for early diagnosis and treatment for patients experiencing headache, through the UH Primary Care Institute. This initiative is directed by Dr. George and is supported by Brian D’Anza, MD, and Jason Ridgel, MD. Another effort is teaching patients how to improve their lifestyle-related headaches. Kristin Kaelber, MD, PhD, from UH Connor Whole Health, is partnering with the UH Neurological Institute headache physicians and resident Molly Adams, MD, to develop a curriculum for “headache school” – group visits/classes for patients suffering migraines.

“We want our patients to get good quality advice on lifestyle choices they can make to help reduce the impact of their headache disorders,” Dr. Reed says.