A PILOT SAFETY AND EFFICACY STUDY OF EPIDURAL PREFRONTAL CORTICAL STIMULATION

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This study is designed to test if electrical stimulation of the surface of the brain in the frontal region will help treat depressive symptoms. The electrical stimulation involves surgically placing the electric leads over the surface of the brain. This type of stimulation is referred to as Epidural Prefrontal Cortical Stimulation (EpCS) and uses Intrel Device (Medtronic, Inc.). This study involves first time research to obtain information about the safety and effectiveness of the EpCS for the treatment of depression. Although the U.S. Food and Drug Association (FDA) has approved the system to be implanted over the spinal cord for patients with chronic pain, its use is still investigational and the surgery is still experimental for patients who have depression. This study represents the first human use of the Intrel Device (Medtronic, Inc.) for the treatment of depression. The National Alliance for Research in Schizophrenia and Depression known as NARSAD sponsors this research. This study plans to enroll up to 15 patients, of whom 5 will be implanted with EpCS and 5 will be followed naturalistically for 1 year.