First-Ever International Migraine Patient Registry and Biorepository Aims to Spur Research

The American Migraine Foundation hopes to foster migraine research by creating the first Migraine Patient Registry and Biorepository. The registry is a proposed international database of information on every person who has migraine, and the biorepository is a planned collection of physical samples of saliva, blood, and other genetic materials, biological fluids, and brain images. All of these resources would be available for migraine research.

The creation of this research resource is one of the major goals of the American Migraine Foundation’s 36 Million Migraine Campaign, which seeks to raise $36 million to fund migraine and headache research and education.

“The goal of the American Migraine Foundation is to develop a multicenter patient registry and biorepository that will transform migraine research and lead to substantial treatment breakthroughs,” said Foundation Chair David W. Dodick, MD, who is also Professor of Medicine at the Mayo Clinic College of Medicine in Rochester, Minnesota. “We hope to be able to assemble a treasure trove of data that researchers can access to find powerful clues to migraine causes and treatments. The data collected in the registry will also help treatment providers tailor existing therapies to specific types of migraine.”

Although progress has been made in understanding the characteristics of many primary headache disorders, large-scale, long-term studies are needed to better explain disease processes, genetic factors, and indicators of the progression of disease,” said Dr. Dodick. “A combination patient registry and biorepository will make these studies possible.”

One of the program’s specific aims is to establish repositories and collection methods for phenotypic data, imaging data, genetic data, and biologic samples. The program also will enroll subjects with primary and secondary headache disorders, and collect phenotypic data, biologic samples (ie, blood, saliva, buccal swabs, CSF, and consent for post-mortem brain tissue), and MRI data.

These data will allow investigators to achieve several of the major scientific aims proposed during recent NIH summits on headache research priorities in the United States. For example, researchers intend to use phenotypic data to test the value of individual International Classification of Headache Disorders (ICHD) diagnostic criteria, compare the specificity and sensitivity of ICHD-II versus ICHD-III Beta diagnostic criteria, and inform future revisions of the classification to allow for more accurate diagnosis.

Epigenetic data, genetic data, biochemical data, and gene expression data will enable investigators to identify gene mutations and variants, (nc-)RNA expression profiles, and epigenetic profiles for diagnostic purposes. Researchers also will use the data to increase molecular insight into pathophysiologic mechanisms of migraine that will guide the design of novel treatment options.

Imaging data also will play a role. Investigators hope to use structural and fMRI data to compare brain structure and function among patients with different headache types and to correlate imaging findings with phenotypic and genetic data. They also plan to develop and evaluate mathematical models of imaging data that best differentiate between headache types.

Repository Would Promote Collaboration
Other goals of the patient registry and biorepository program are to establish and train a larger network of investigative sites (eg, participating sites in the American Migraine Foundation Academic Headache Center Initiative) to enroll subjects, submit data, and access all collected data for specific research investigations. The organizers intend to make data accessible to all scientists. Grant applications will also be accepted for review and high-value, high-yield projects will be funded.

According to the American Migraine Foundation, the establishment and use of a large, longitudinal, publicly assessable headache repository would transform headache research by facilitating collaborations among investigators from numerous institutions, pooling physical and intellectual resources from national and international experts, allowing for analyses of large cohorts of patients with primary and secondary headache disorders, linking phenotypic data with biologic specimens and imaging data, and allowing for longitudinal analyses.

—Glenn S. Williams