Prefrontal Cortical Stimulation for Severe Treatment-Resistant Depression
This study is testing if electrical stimulation of the brain's surface, called Prefrontal Cortical Stimulation (PCS), can help treat severe depression that hasn't responded to other treatments. You might be eligible if you are between 22 and 70 years old, have had depression for at least two years, and haven't improved after trying four or more different antidepressant treatments. The study involves surgically placing small electrical leads on the surface of your brain, which are connected to a pacemaker-like device (Proclaim Elite SCS System or Eterna SCS System by Abbott Laboratories). Researchers will measure changes in your depression symptoms using the HRSD Scores after 12 months to see if the treatment is successful. The study aims to enroll 15 participants, but its current recruitment status is unclear.
- Study design
- This is an interventional study with a planned enrollment of 15 participants. The study does not specify if it is randomized or blinded.
- What's involved
- You would undergo a 14-day baseline period for eligibility, including medical tests and assessments. If eligible, you would be hospitalized for at least 3 days for surgery to implant the device, followed by 10 follow-up visits over 19 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your depression symptoms will be measured at 12 months after the start of the study.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT04124341
PCS in Severe Treatment Resistant Depression
Recruiting
NAAges 22–70InterventionalTreatmentUniversity of MinnesotaInvestigator-initiated
~15 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:Prefrontal Cortical Stimulation (PCS)
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in HRSD Scores
Measured over 12 months
Conditions
Where it's being run
1 sites across 1 statesMinnesota1
Study leadership
- Ziad Nahas, MD · PRINCIPAL_INVESTIGATOR · University of Minnesota
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Participant must be able to provide written informed consent.
Participant has a diagnosis of major depressive episode that is chronic or recurrent as defined by DSM-5 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 ECT (Electroconvulsive Therapy) or refused to undergo ECT if clinically indicated to them
Participant must have HRSD greater than or equal to 20 at study entry
Participant must be able to complete the evaluations needed for this study including the functional imaging scans and the EEG Bayesian optimization sessions
Participant must be under the care of a licensed psychiatrist, undergoing regular care evaluations, and inform study team of any change to care team during study participation
Participant must agree to allow all forms of communication between investigators and study staff and any health care provider (current or having provided service within two years of enrollment)
Participant must provide name and contact information for at least two people greater than or equal to 22 in age who reside within a 30 minute drive of the participant's residents and whom staff may contact as necessary during study participation
Participant must be enrolled in a Medicare program
Participant must be able to provide written informed consent.
Participant has a diagnosis of major depressive episode that is chronic or recurrent as defined by DSM-5 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 ECT (Electroconvulsive Therapy) or refused to undergo ECT if clinically indicated to them
Participant must have HRSD greater than or equal to 20 at study entry
Participant must be able to complete the evaluations needed for this study including the functional imaging scans and the EEG Bayesian optimization sessions
Participant must be under the care of a licensed psychiatrist, undergoing regular care evaluations, and inform study team of any change to care team during study participation
Participant must agree to allow all forms of communication between investigators and study staff and any health care provider (current or having provided service within two years of enrollment)
Participant must provide name and contact information for at least two people greater than or equal to 22 in age who reside within a 30 minute drive of the participant's residents and whom staff may contact as necessary during study participation
Participant must be enrolled in an active health insurance plan that will cover the costs associated with standard health care services and injuries
Exclusion
The PCS would (in the investigator's judgment) pose an unacceptable surgical or medical risk for the participant
Participant is unable to undergo required full body magnetic resonance imaging (MRI) during the clinical study
Participant is judged by the investigator to be acutely suicidal (e.g. within the 30 days prior to the PCS implant the participant has made a suicide attempt or gesture or has made specific plans or preparation to commit suicide or scores 21 or higher on the MSSI)
In addition to the acute suicidal risks mentioned above, participant meets any of the following:
Participant has a history of schizophrenia, schizoaffective disorder, or other psychotic disorder, or a current major depressive episode that includes psychotic features (commonly referred to as psychotic depression) according to the DSM V criteria
Participant with a diagnosis of dementia with a Mini-Mental State Exam (MMSE) less than or equal to 23
Participant with a positive urine pregnancy test
Participant with a positive urine drug screen
Participant with DBS (Deep Brain Stimulator)
Participant with VNS (Vagus Nerve Stimulator) if the device was active in the last 6 months prior to study enrollment
Participant with history of seizures
Participant determined by surgical safety committee to have cerebral atrophy, neurodegenerative or neurovascular disease due to age or medical condition that would prohibit optimal surgical safety, per clinical MRI
The PCS would (in the investigator's judgment) pose an unacceptable surgical or medical risk for the participant
Participant is unable to undergo required full body magnetic resonance imaging (MRI) during the clinical study
Participant is judged by the investigator to be acutely suicidal (e.g. within the 30 days prior to the PCS implant the participant has made a suicide attempt or gesture or has made specific plans or preparation to commit suicide or scores 21 or higher on the MSSI)
In addition to the acute suicidal risks mentioned above, participant meets any of the following:
Participant has a history of schizophrenia, schizoaffective disorder, or other psychotic disorder, or a current major depressive episode that includes psychotic features (commonly referred to as psychotic depression) according to the DSM V criteria
Participant with a diagnosis of dementia with a Mini-Mental State Exam (MMSE) less than or equal to 23
Participant with a positive urine pregnancy test
Participant with a positive urine drug screen
Participant with DBS (Deep Brain Stimulator)
Participant with VNS (Vagus Nerve Stimulator) if the device was active in the last 6 months prior to study enrollment
Participant with history of seizures
Participant determined by surgical safety committee to have cerebral atrophy, neurodegenerative or neurovascular disease due to age or medical condition that would prohibit optimal surgical safety, per clinical MRI
What this trial measures
- Change in HRSD Scores12 months
Determine clinical change in depressive symptoms over first year of treatment