This research study is designed to test the effectiveness of electrical stimulation on the surface of the brain to treat depressive symptoms. The electrical stimulation specifically targets the outer layer of both sides of the brain right behind the forehead and is known as prefrontal cortical stimulation (PCS). Enrolled participants go through screening, including MRI, evaluation of depressive symptoms and treatments, and medical evaluations. If they qualify, they will have surgery so that electric leads can be placed on the surface of the brain. These leads are then connected to two pacemaker-like devices surgically placed beneath the collarbone (the Proclaim Elite SCS or the rechargeable Eterna System manufactured by Abbott Laboratories). To track how well the device works, the study also requires regular research visits to review depressive symptoms, test the brain’s response to the stimulation using EEG, and personalize device stimulation settings. Most of these visits take place during the first year of the research (19 visits), and participants will be seen four times per year for four additional years to track long term outcomes. Some of these visits can take place over zoom.
Study Inclusion Criteria: Participants must: | Study Exclusion Criteria: Participant must not: |
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