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Clinical Trial

PCS in Severe Treatment Resistant Depression

NCT: NCT04124341 · RECRUITING

NCT IDNCT04124341
StatusRECRUITING
Start Date2021-09-29
Completion2032-12-31
SponsorUniversity of Minnesota (OTHER)
First posted
Last updated

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.

Frequently Asked Questions

What is PCS in Severe Treatment Resistant Depression?

PCS in Severe Treatment Resistant Depression is a clinical trial registered under NCT04124341. Current status: RECRUITING.

What is the status of NCT04124341?

The current status of NCT04124341 (PCS in Severe Treatment Resistant Depression) is: RECRUITING.

When did PCS in Severe Treatment Resistant Depression start?

PCS in Severe Treatment Resistant Depression started on 2021-09-29.

Related Devices

Official Source

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Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.