Deep brain stimulation study gets FDA approval

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St. Jude Medical received FDA approval for a 20-site study to investigate whether a deep brain stimulation system is a safe and effective method for treating severe depression. Enrolling up to 125 patients diagnosed with major depressive disorder, the “Broaden study”—named for the area of the brain known as Brodmann Area 25—will look at whether St. Jude’s deep brain stimulation system, dubbed “Libra,” can help patients suffering from the condition.

“Deep brain stimulation could potentially change the way that we look at treating patients suffering with severe depression,” said Mark George, MD, distinguished professor of psychiatry, radiology and neurology at the Medical University of South Carolina. “Treatments such as medications, psychotherapy and electroconvulsive therapy often fail to work for these very difficult-to-treat patients, so we are hopeful this research will provide us with a new approach to treating this debilitating condition.”

Deep brain stimulation involves using mild pulses of current from a surgically implanted device to stimulate the brain. The device is placed in a specific location of the brain and connected to a neurostimulator that is placed under the skin near the collarbone. The patient is then given a controller for the stimulator.

Prior to this study, the deep brain stimulation system was evaluated in three centers in Chicago, New York City and Dallas, according to St. Jude. The expansion is being conducted under an FDA investigational device exemption, and participants must be classified as having treatment resistant depression and must have failed multiple treatments to be a candidate. St. Jude said it will request approval to expand the study to a total of 231 patients at a later date.

The study will build upon the depression work of a research team from the University of Toronto, led by neurologist Helen S. Mayberg, MD, and neurosurgeon Andres Lozano, MD, PhD, FRCSC. The earlier study reported that in six months, 62 percent of patients experienced at least a 40-percent decrease in depression symptoms as measured by the Hamilton Rating Scale for Depression. Of those, 92 percent maintained that improvement at a follow-up visit typically a year later.

"We are committed to leading this important research in hopes of finding a solution for people who currently don't have a treatment option," said Chris Chavez, president of the St. Jude Medical Neuromodulation Division. "By expanding the Broaden study, we are able to continue to add to the body of evidence that will determine if deep brain stimulation is indeed an option for managing major depressive disorder."

For more information, visit St. Jude’s website.