Stanford clinical trial on migraines seeks participants

Of the 37 million Americans who suffer from migraines, a few million progress to a chronic stage of having them more often than not. Stanford investigators hope to find out why.

- By Bruce Goldman

Robert Cowan

Researchers at the Stanford University School of Medicine are recruiting participants for a clinical trial aimed at finding out why some people who suffer occasional migraine headaches progress to a chronic stage of frequently occurring migraines.

The trial, underway for about two years now, has recruited more than 200 participants, and investigators are seeking another 300. Candidates must be 18 years or older. The researchers want to enroll not just people who experience migraines or other headache types, but also people who don’t have headaches at all to serve as control subjects.

“Our understanding of headaches lags well behind that for many other neurological conditions, which is sad since it’s the most common neurologic complaint a doctor will see,” said the trial’s principal investigator, Robert Cowan, MD, professor of neurology and neurological sciences.

“Everyone knows at least someone who suffers with migraine,” said Cowan, who holds the Betty Higgins Family Foundation Professorship in Headache Medicine and is the director of Stanford’s Headache and Facial Pain Center.

Costly condition

Of the 60 million people in the United States who get headaches, he said, 37 million of them get migraines — intense throbbing headaches often accompanied by nausea and/or hypersensitivity to sound and light. Among a substantial fraction of migraine sufferers, this painful experience is preceded by a characteristic premonitory, often visual, disturbance known as an aura. 

Everyone knows at least someone who suffers with migraine.

Cowan experienced his first migraine at age 5. More typically, though, migraines hit people hardest during their most productive years. There’s an uptick of migraine incidence in the teen years and early adulthood, when people are getting their educations, starting families and building careers.

For as-yet unknown reasons, women are three times as likely as men to suffer from migraines.

The bulk of the estimated $15 billion to $30 billion annual cost of headaches to the U.S. economy is accounted for by loss of work productivity, said Cowan. These people, who experience symptoms more days than not, number in the millions.

For the majority of patients with migraines, the most effective prescriptions are lifestyle recommendations, he said. “Don’t skip meals, keep regular hours and get daily exercise — don’t just sit around.”

Better understanding sought

Why some people are susceptible to migraines and why some — but not others — who do get them become more susceptible over time isn’t well understood, Cowan said.

“The basic question we’re addressing is: Why do some people get occasional headaches while others get headaches with increasing severity and disability? Are chronic migraines just episodic migraines that occur more often? We suspect not,” he said.

The investigators will conduct rigorous analyses of trial participants’ blood, brain function and cerebral spinal fluid in an effort to find factors that correlate with migraine susceptibility, severity and frequency.

Participants will be asked to fill out medical questionnaires and report to the Stanford campus for a minimum of two or three roughly one- to two-hour medical visits. (Free parking will be provided.) The investigators will draw participants’ blood and record their brain activity using functional magnetic resonance imaging and perform lumbar punctures, also known as spinal taps. Participants who agree to undergo fMRI or lumbar punctures will receive compensation of $50 apiece for each procedure.

“If we can find risk factors that predispose some migraine patients’ progression from an episodic to a chronic condition, and use these to identify at-risk patients, it may provide insight into personalized treatments to prevent episodic headaches from becoming chronic,” said Cowan.

Prospective participants who want to learn more about the trial or about their potential eligibility for it are encouraged to contact trial coordinator Bharati Sanjanwala at

The trial is funded by the Sun Star Foundation.

About Stanford Medicine

Stanford Medicine is an integrated academic health system comprising the Stanford School of Medicine and adult and pediatric health care delivery systems. Together, they harness the full potential of biomedicine through collaborative research, education and clinical care for patients. For more information, please visit

2024 ISSUE 1

Psychiatry’s new frontiers