Headache specialists at NYU Langone Health are engaged in cutting-edge studies designed to advance the diagnosis, treatment, and therapy adherence for headache. A range of active clinical trials are targeting the expanded adoption of approved, evidence-based prevention approaches, while others are testing the efficacy of novel drugs and behavioral treatment strategies to prevent and treat even the most severe and refractory headaches.

Eliminating Barriers to Behavioral Therapies

One body of research from NYU Langone’s Division of Headache targets migraine prevention. A major focus is the use of Level A, evidence-based treatment approaches combining medication and behavioral options, such as cognitive behavioral therapy, biofeedback, and progressive muscle relaxation (PMR) therapy. Despite their proven long-term benefits, these therapies are underused, for reasons including access issues and prohibitive costs.

“These are proven, safe therapies that in some cases have demonstrated greater cost effectiveness compared to medications, but patients aren’t utilizing them, often due to the time it takes to visit a therapist and learn the skills,” notes Mia T. Minen, MD, MPH, assistant professor in the Department of Neurology. “We wanted to create a scalable, accessible form of behavioral therapy.”

With accessibility and ease of use a central focus, Dr. Minen’s team developed a smartphone app, RELAXaHEAD, which features an electronic headache diary and integrated analytics to deliver PMR therapy and track patient adherence. In a pioneering, single-arm study of 51 patients, published in June 2019 in npj Digital Medicine, researchers saw a mean month-over-month reduction of 2 headache days in frequent app users. Additional, ongoing studies are investigating the app’s use in other clinical settings, such as the emergency department (ED), to uncover how best to enhance user engagement and maximize the app’s prevention efficacy.

Expanding Effective Headache Treatment Options for Children and Adults

At the same time, other clinical investigations are focused on expanding available treatment agents. One, a stage III trial of calcitonin gene-related peptide (CGRP) antagonists, examines the effectiveness of intravenous infusion as a delivery method for this new class of medications developed specifically for migraine. Another trial is examining the use of a neurostimulation device in adolescent patients ages 12 to 17. The device, which is already approved by the U.S. Food and Drug Administration (FDA) for adult patients, offers a nonmedical treatment option targeting acute migraine pain signaling in the brain with smartphone-controlled electronic frequency.

Recruitment of adolescent subjects for the trial coincides with the addition of Valentina Popova, MD, as New York City’s only pediatric and adolescent headache specialist. “The needs of the pediatric and adolescent communities are very different from the needs of adults in the context of headache,” says Thomas Berk, MD, clinical assistant professor of neurology. “In this population specifically, it’s a priority to find nonmedical treatments through this and other studies.”

Additional drug and device trials and retrospective studies are ongoing, targeting specific headache subtypes, such as menstrual migraine, vestibular migraine, and concussion-related headaches, as well as specific outcomes based on medication usage.

Establishing Consistency in Clinical Care

At the broader clinical care level, researchers are working to expand adoption of best practices and guidelines—many developed at NYU Langone—both within and beyond the health system. One such study involved a chart review of headache-specific care offered by two NYU Langone urgent care sites, which patients seeking evaluation and treatment of migraine are increasingly using as an alternative to the ED.

“We found that most patients presenting at these urgent care locations had episodic, acute migraine and were not undergoing regular migraine care with an NYU Langone physician,” notes Dr. Minen. “The study identified opportunities to further standardize quality migraine care and ensure that the sites’ pharmacies are appropriately stocked with acute migraine medications.”

Similar research, undertaken in partnership with the New York City Department of Health and Mental Hygiene, analyzed presentations of migraine among 10,240 patients at 67 urgent care centers across the city—confirming both a high rate of use by patients with acute migraine and the need for standardization of care. “As these centers increasingly offer a desirable ED alternative for patients seeking migraine care, it’s vital to continue to examine their protocols to ensure these patients receive the highest-quality care as treatments evolve.”

Eliminating Misconceptions by Equipping Physicians for Quality Migraine Care

The gap in patient access to quality migraine care leads to both misdiagnosis and misconceptions—even undue stigma—around migraine symptoms and severity. NYU Langone headache specialists are at the forefront of education efforts to both increase the availability of subspecialty headache care as well as equip neurologists, primary care physicians, and other specialists to recognize migraine and provide high-quality care.

Physician education often takes the form of close multidisciplinary collaboration, as referrals within the NYU Langone network reflect the nuanced diagnosis and treatment approach needed to manage headache, which is associated with more than 300 medical conditions. “There’s a lot of interplay across specialties as patients are evaluated, not only due to overlap with other neurological conditions, but because so many secondary conditions—from Lyme disease to TMJ dysfunction—can ultimately be discovered at the root of a patient’s headaches,” notes Lawrence C. Newman, MD, professor of neurology and director of the Division of Headache.

A prospective study in development proposes a population-based approach to evaluate the impact of migraine education on outcomes, focusing on NYU Langone employees who experience migraine. An employee education campaign will disseminate information about symptom management and migraine treatment, while a clinician lecture series will educate primary care physicians regarding available medications and neurology referral. Those clinicians can then be identified within the health system as trained in headache management. Researchers will assess whether patients experience less absenteeism and better outcomes.

“If we’re able to validate that an employee education approach can lead to better quality diagnosis and care, it could eventually be applied within other organizations and help to reduce employer misconceptions around migraine,” adds Dr. Newman. “Extending migraine care starts with expanding awareness and equipping more clinicians to care for headache patients—and the workplace could offer a platform to achieve that.”