Actively Recruiting
PCS in Severe Treatment Resistant Depression
Led by University of Minnesota · Updated on 2026-01-20
15
Participants Needed
1
Research Sites
587 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research study is designed to test if electrical stimulation of the surface of the brain in the frontal region will help treat depressive symptoms. Participants receive intermittent electrical stimulation to the brain, which involves surgically placing electric leads in between the tough fibrous membrane covering the surface of the brain and the surface of the brain itself. This type of stimulation is referred to as bilateral subdural prefrontal cortical stimulation (PCS) because it will specifically target the outer layer of the brain at the midline, right behind the forehead. It uses a pacemaker-like device, the Proclaim Elite SCS System (non-rechargeable) or the Eterna SCS System (rechargeable), both by Abbott Laboratories for stimulation. Although the U.S. Food and Drug Administration (FDA) has approved the Proclaim Elite SCS system for brain stimulation for patients with chronic pain and muscular diseases, such as Parkinson's, its use is still investigational, and the surgery is still experimental for patients who have depression.
CONDITIONS
Official Title
PCS in Severe Treatment Resistant Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must be able to provide written informed consent.
- Participant has a diagnosis of chronic (greater than or equal to 2 years) depressive episode as defined by DSM V criteria.
- Participant has not had an adequate response to four or more adequate antidepressant treatments from at least two different antidepressant treatment categories in the current depressive episode according to the Antidepressant Treatment History Form (ATHF).
- Participant must have had electroconvulsive therapy (ECT) or refused to undergo ECT if clinically indicated.
- Participant must have a Hamilton Rating Scale for Depression (HRSD) score greater than or equal to 20 at study entry.
- Participant must be able to complete the evaluations needed for this study including functional imaging scans and EEG Bayesian optimization sessions.
- Participant must be under the care of a licensed psychiatrist, undergoing regular care evaluations, and notify the study team of any changes to the care team during participation.
- Participant must agree to allow all forms of communication between investigators, study staff, and any health care provider (current or within two years prior to enrollment).
- Participant must provide name and contact information for at least two people aged 22 or older who live within a 30-minute drive and who may be contacted as needed during the study.
- Participant must be enrolled in a Medicare program.
You will not qualify if you...
- PCS would pose an unacceptable surgical or medical risk according to the investigator.
- Participant is unable to undergo full body magnetic resonance imaging (MRI) during the study.
- Participant is judged acutely suicidal (e.g., suicide attempt or plans within 30 days prior to implant, or scores 21 or higher on MSSI).
- Participant has made a suicide attempt requiring medical treatment within the past 12 months.
- Participant has made two or more suicide attempts in the past 12 months.
- Participant has a clear plan for suicide and cannot guarantee contacting their psychiatrist or investigator if suicidal urges increase.
- Participant is likely to attempt suicide within six months according to the investigator.
- Participant has a history of schizophrenia, schizoaffective disorder, or other psychotic disorders, or psychotic depression.
- Participant has dementia with a Mini-Mental State Exam (MMSE) score less than or equal to 23.
- Participant has a positive urine pregnancy test.
- Participant has a positive urine drug screen.
- Participant has a deep brain stimulator (DBS).
- Participant has an active vagus nerve stimulator (VNS) used within 6 months prior to enrollment.
- Participant has a history of seizures.
- Participant has cerebral atrophy, neurodegenerative or neurovascular disease that would prevent safe surgery as determined by surgical safety committee based on MRI.
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
Research Team
Z
Ziad Nahas, MD, MSCR
CONTACT
R
Rachel Johnson, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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