Researchers are evaluating whether deep brain stimulation (DBS) can safely and effectively help adults with treatment-resistant depression when used alongside usual care.

DBS (Deep Brain Stimulation) is a medical procedure that uses a small implantable device to send gentle electrical signals to a specific part of the brain. The procedure is currently FDA approved for certain mobility disorders, but this study is investigational meaning it is being used to evaluate depression. The system is placed by a trained neurosurgeon and programmed over time by the clinical study team. 

Every eligible participant in this study receives the device implant—there are no “dummy” devices. However, to scientifically prove if the treatment works, the study uses a “delayed stimulation” design, where one group will have the device turned ON shortly after the procedure and the other will have the device turned on after 12 months. You will not know which group you are a part of until after your 12th month visit. 

After the first year, all eligible participants will receive active stimulation therapy.  

You should keep your current depression medicines and therapy the same. If you join, the study doctor will guide any changes.

Participation is approximately 3 years from the time of your procedure. This timeline ensures that researchers can safely monitor your progress and the long-term effects of the device. Over the entire 3-year period, you can expect about 20-22 scheduled visits with the study team, including initial baseline visits. There may be options for remote care if necessary. 

No. The study does not require the device to be removed once your participation is over. Many people choose to keep the system in place after the study ends. However, if you prefer to have it removed, you can discuss this option with your study doctor, who will help determine what is best for you. 

The study team closely monitors the device throughout your participation. If a medical issue, personal preference, or device-related problem requires removal, the system can be safely explanted by a neurosurgeon. Removing the device would end your participation in the study, and your care would return to your regular healthcare providers. 

All participants will also need one planned device replacement during the study because the first implanted battery will eventually run low. This replacement is part of the normal study schedule and is performed by a trained neurosurgeon.

All study-specific requirements are covered, and participants may receive reimbursement for reasonable travel expenses associated with study visits, in accordance with site-specific policies.