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Enrolling studies
Advancing Innovation in Migraine (AIM)
At the David S. and Ruth L. Gottesman Center for Headache Treatment and Translational Research, our goal is simple: to help each person with migraine find the treatment that works best for them — as early as possible. We believe migraine care should be determined by individual patient needs and treatment response, not limited by a “one-size-fits-all” approach or insurance barriers.
To help advance more personalized migraine care, we are building a precision medicine research registry that collects information about migraine symptoms, medical history, lifestyle factors, and treatment experiences. By learning from people living with migraine, we hope to better understand why certain treatments work well for some individuals but not others, and to improve access to effective therapies and individualized care approaches — including areas such as hormonal influences and hormone replacement therapy.
Participation involves completing questionnaires that can be done on a smartphone or computer either at home or in the office. Participants will receive a $25 gift card for their time.
For more information about enrollment or participation, please contact us.
STress REsponse in pAtients with Migraine (STREAM)
The MAP Research Program is studying how the autonomic nervous system (ANS) — the body’s fastest stress response system — may contribute to migraine symptoms, treatment response, and disease progression. The ANS helps control functions such as heart rate, blood pressure, sleep, digestion, and the body’s response to stress. Researchers believe differences in ANS functioning may help explain why migraine affects people so differently, and why some treatments may work for some individuals with migraine, but not others.
In the STREAM study, we combine specialized autonomic testing with wearable device technology, that is worn at home, to better understand the biological patterns associated with migraine.
In collaboration with our colleagues at the Friedman Brain Institute, we also use advanced brain imaging to study how migraine affects the brain and nervous system function — including how newer CGRP-targeting migraine treatments may influence these systems.
Our goal is to advance our understanding of mechanisms that lead to migraine, and move toward more personalized migraine care by identifying biological patterns that may help predict which treatments are most effective for different individuals. We hope this research will ultimately identify novel treatment targets and advance precision medicine approaches for people living with migraine.
Participants are compensated for their time. For more information about enrollment or participation, please contact us.
Middle Meningeal Artery (MMA) embolization for treatment-resistant chronic migraine (NCT06735833)
IIn partnership with our colleagues in the Department of Neurosurgery, the David S. and Ruth L. Gottesman Center for Headache Treatment and Translational Research is offering eligible patients the opportunity to participate in a clinical research study evaluating a new potential treatment approach for refractory chronic migraine.
This multi-center study is investigating the safety and effectiveness of middle meningeal artery (MMA) embolization using the TRUFILL n-BCA liquid embolic system in individuals living with treatment-resistant chronic migraine.
The middle meningeal artery (MMA) is a blood vessel located within the lining that surrounds the brain (the meninges). Researchers believe this artery may play a role in migraine-related pain and inflammation in some individuals with chronic migraine. MMA embolization is a minimally invasive procedure performed through the blood vessels that reduces blood flow through the MMA in an effort to decrease migraine activity.
Researchers hope this approach may help reduce headache frequency, severity, and migraine-related disability in people who have not responded adequately to currently available treatments.
For individuals living with chronic migraine who continue to experience significant symptoms despite multiple therapies, this study may offer access to an innovative investigational treatment approach while helping researchers better understand new pathways for migraine care.
This study is funded by Johnson & Johnson. For more information about eligibility or participation, please contact us here.
The APT comparison study: A comparative effectiveness study of oral medications used for migraine prevention. Clinical trial (NCT06972056)
The David S. and Ruth L. Gottesman Center for Headache Treatment and Translational Research at Mount Sinai is an enrolling site for the APT Comparison Study.
Frequently, clinical trials determine how well a medication works by comparing effectiveness to a placebo – not to currently available treatments. Typically, people living with migraine need to try older non-specific migraine medications before insurance will cover new migraine-specific agents that target CGRP, such as atogepant. This clinical trial aims to change this by comparing atogepant, with two commonly used older migraine prevention medication, propranolol and atogepant, to better understand the added value or a new targeted migraine prevention strategies.
Participants in the study will be randomly assigned to one of the treatment groups and followed over time so researchers can evaluate changes in migraine frequency, symptom burden, side effects, and quality of life. By directly comparing these medications this study may help determine which preventive treatments are most effective and best tolerated for different individuals. Importantly, the results could support broader access to newer, migraine-specific treatments as a first option—without requiring patients to first try older, non-specific medications—ultimately improving future migraine care. This study is funded through a grant from the Patient Centered Outcomes Research Institute (PCORI). Please contact us if you are interested in enrolling.
For more information about eligibility orparticipation, please contact us here.
Ultrasonic Neuromodulation of Cingulate Cortex for Fibromyalgia Clinical Trial (NCT07226648)
At the David S. and Ruth L. Gottesman Center for Headache Treatment and Translational Research, we know that many people with migraine also experience
other pain conditions. We are currently enrolling participants in a study funded by SPIRE to better understand how migraine and other chronic pain conditions interact and affect health, symptoms, and quality of life.
Researchers believe this overlap occurs because changes in the brain’s processing of pain and sensory inputs—such as smell, sound, and light—heighten vulnerability not only to migraine attacks but also to other chronic overlapping pain conditions (COPCs). One of the most common COPCs is fibromyalgia.
Unfortunately, many medications used to treat these pain conditions can cause unwanted side effects, such as fatigue.
Researchers have demonstrated that targeted low-intensity focused ultrasound applied to the scalp can modulate activity in the cingulate cortex, a key brain region involved in pain processing. After several sessions of targeted ultrasound, patients with fibromyalgia had significantly less pain. The goal of this clinical trial is to evaluate the effectiveness of this therapy in a larger patient population. Participants will receive four treatments (each lasting 40-60 minutes) over the course of one month and will complete surveys at multiple time points throughout the 16-week study. Participants will be compensated for their time.
This study is funded by SPIRE. For more information about eligibility or participation, please contact us here.
