PCS in Severe Treatment Resistant Depression

NCT04124341 | Recruiting DMC FDA Device

• 1 other identifier: PSYCH-2019-27331
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Treatment Resistant Depression

Outcome Measures

Primary Outcomes (1)

• Change in HRSD Scores

  Determine clinical change in depressive symptoms over first year of treatment

  12 months

Secondary Outcomes (1)

• Change in HRSD Scores

  60 months

Study Arms (1)

Prefrontal Cortical Stimulation (PCS)

EXPERIMENTAL

Stereotactically implanted bilateral PCS

Device: Prefrontal Cortical Stimulation (PCS)

Interventions

Prefrontal Cortical Stimulation (PCS) DEVICE

Prior to surgery, subjects will undergo a high resolution structural scan to identify anatomical landmarks for rostral anterior and lateral prefrontal cortex. Following identification of target areas, PCS quad leads will be projected over the anterior and lateral prefrontal cortex. Subjects will be kept in the hospital for a minimum of 72 hours for observation during which the investigators will obtain a high resolution spiral CT scan without contrast to confirm lead placements post-operatively and rule out any intra-cranial bleeds. Patients will receive analgesics which they may continue as an outpatient on as needed basis. During this 2-3 weeks recovery period, the attention to pain control and mood is critical. The research team will contact patients at least twice per week to check on their status.

Prefrontal Cortical Stimulation (PCS)

Eligibility Criteria

• Age: 22 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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

You may not qualify if:

• 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:
• Has made a suicide attempt within the previous 12 months that required medical treatment
• Has made greater than or equal to two suicide attempts in the past 12 months
• Has a clear-cut plan for suicide that states that she/he cannot guarantee that she/he will call her/his regular psychiatrist or the Investigator if the impulse to implement the plan becomes substantial during the study
• Is likely to attempt suicide within the next six months, in the Investigator's opinion
• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Ziad Nahas, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ziad Nahas, MD, MSCR

CONTACT

952-525-4505; znahas@umn.edu

Rachel Johnson, PhD

CONTACT

952-525-4505; ipl@umn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2019
• First Posted: October 11, 2019
• Study Start: September 29, 2021
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2032
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)