Prefrontal Cortical Stimulation (PCS) for Severe Treatment Resistant Depression

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 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.  

Study Inclusion Criteria: Participants must:

Study Exclusion Criteria: Participant must not:

  • Be 22 to 55 years old and enrolled in a Medicare program.
  • Be under the care of psychiatrist
  • Have a diagnosis of a chronic depressive episode that has not had an adequate response to three or more adequate antidepressant treatments.
  • Have tried ECT or refused to undergo ECT if it was clinically indicated.
  • Be able to consent to the study and complete the evaluations needed for this study, including the MRI and the EEG sessions. 
  • Have medical or mental health conditions that pose an unacceptable risk for the procedure or use of the device
  • Be unable to have a full body MRI
  • Be acutely suicidal OR have had a suicide attempt in the past 12 months OR be likely to attempt suicide in the next 6 months.
  • Be pregnant 
  • Have DBS or VNS  
Representation of PCS surgical devices in human figure

To learn more about the PCS research study or to refer patients for the study, please contact the Interventional Psychiatry Lab study team, overseen by Dr. Ziad Nahas, Department of Psychiatry and Behavioral Studies, University of Minnesota. 

952-525-4505 OR [email protected].

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