The BROADEN (BROdmann Area 25 DEep brain Neuromodulation) study will evaluate the safety and effectiveness of deep brain stimulation in patients with severe depression who have not responded to multiple treatments. Stimulation to the brain is provided by a neurosurgically implanted medical device called a deep brain stimulation (DBS) system. The DBS system provides stimulation directly to a focused area of the brain known as Brodmann Area 25 (sometimes referred to as BA25). The study will build upon the depression work of a research team from the University of Toronto, led by neurologist Helen S. Mayberg, M.D. and neurosurgeon Andres Lozano, M.D., PhD, FRCSC.
Participants in this study must
Participants should continue to take their current medications and participate in counseling during this study, but their psychiatric care must be transferred to the clinical study team for the duration of the study. Participants will receive the device, the surgical procedure, and study-related follow-up care free of charge. See the informed consent form, a separate document, for details.
The BROADEN study has specific rules about who can participate, how many can participate, and what procedures must be followed during the study.
You may be able to participate if you
If you meet these criteria and would like more information, contact the clinical study call center toll-free at 877-788-3916.
Participants should consider the study time commitments and their ability to see the study doctors as required before agreeing to participate.
The study visits include
*In addition to surgery, there is usually one visit to the neurosurgeon prior to surgery and one follow-up visit after surgery.
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