PCS in Severe Treatment Resistant Depression

Treatment Resistant Depression Clinical Trial

Official title: Prefrontal Cortical Stimulation (PCS) for Severe Treatment Resistant Depression

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

This study has five distinct stages.

Stage 1: Baseline Assessments There is a 14-day baseline period to determine eligibility, including medical history, physical and neurological examinations, and medical test including EKG, blood work, pregnancy test, depression assessments and cognitive assessments. An MRI will also be done prior to implant in order to help the surgeon determine where best to place the leads.

Stage 2: Surgery If deemed to be medically eligible, participants will be hospitalized for a minimum of 3 days, during which they will undergo surgery to implant the device and leads. There will be testing of the leads to explore optimal testing parameters. According to the surgeon's judgment, participants may or may not receive stimulation for 3 weeks following surgery.

Stage 3: Acute phase (19 weeks) Following implantation, participants undergo a CT scan to ensure proper implantation. Later, participants complete 10 follow up visits where assessments of symptoms will be made. Additionally, the first visit will consist of the investigator programming the stimulator while participants watch various photographs with different emotional content and have their brain electrical activity recorded. This will help the investigator choose the best settings for treatment. Pregnancy tests will be done as appropriate.

Stage 4: Follow up (7 months) All participants who complete stage 3 will be offered continued treatment. Participants complete 7 monthly follow-up visits where assessments of symptoms are made. Pregnancy tests will be done as appropriate.

Stage 5: Long Term Follow up (4 years) All participants who complete stage 4 will be offered continued treatment. Participants complete follow up visits every three months, alternating between in person and over zoom. Assessments of symptoms are made. Pregnancy tests will be done as appropriate.

Objectives To demonstrate that PCS causes meaningful and sustained antidepressant response.

To demonstrate that precision functional mapping can identify individualized depression patterns which will lead to personalized maps for targeting the stimulation for an individual.

To establish safe parameters for PCS that do not generate after discharge seizures. ;

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Treatment-Resistant
• Treatment Resistant Depression

• NCT number: NCT04124341
• Study type: Interventional
• Source: University of Minnesota
• Contact: Ziad Nahas, MD, MSCR
• Phone: 952-525-4505
• Email: znahas@umn.edu
• Status: Recruiting
• Phase: N/A
• Start date: September 29, 2021
• Completion date: December 31, 2027