RecruitingNot ApplicableNCT04124341

PCS in Severe Treatment Resistant Depression

Prefrontal Cortical Stimulation (PCS) for Severe Treatment Resistant Depression


Sponsor

University of Minnesota

Enrollment

15 participants

Start Date

Sep 29, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 22 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a small implantable device called PCS (Precision Closed-loop Stimulation) as a treatment for people with severe, long-lasting depression that has not responded to many other treatments. **You may be eligible if...** - You have been diagnosed with depression lasting 2 or more years - You have tried 4 or more different antidepressant medications without relief - You have had, or were offered and declined, electroconvulsive therapy (ECT, also called shock therapy) - Your depression score on a standard scale is high at the start of the study - You are enrolled in Medicare - You are able to have brain MRI scans and EEG sessions - You are under the regular care of a licensed psychiatrist **You may NOT be eligible if...** - You already have a deep brain stimulator or an active vagus nerve stimulator - You have a history of schizophrenia, psychotic disorder, or seizures - You have been actively suicidal recently or have made a suicide attempt in the past year requiring medical care - You have dementia or significant memory problems - You are pregnant or have a positive drug screen - The surgery poses too high a medical risk for you Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPrefrontal Cortical Stimulation (PCS)

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.


Locations(1)

University of Minnesota

Minneapolis, Minnesota, United States

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NCT04124341


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