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NCT04124341 · ClinicalTrials.gov registry record · NA
PCS in Severe Treatment Resistant Depression
A NA study of Treatment-Resistant Depression, sponsored by University of Minnesota.
- Recruiting
- Registry status
- NA
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT04124341 is a NA study of Treatment-Resistant Depression that is actively recruiting participants, run by University of Minnesota. The registered enrollment target is 15 participants, below the 374-participant average among 54 other Treatment-Resistant Depression trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04124341, a NA study of Treatment-Resistant Depression, is actively recruiting participants, sponsored by University of Minnesota.
- RECRUITING
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- DEVICE Prefrontal Cortical Stimulation (PCS)
Study Locations (1)
Minnesota
- University of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2021-09-29 |
| Est. Completion | 2032-12-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04124341
The ClinicalTrials.gov registry entry for NCT04124341 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 374-participant average among 54 other Treatment-Resistant Depression trials with a reported enrollment target (96% lower). The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Treatment-Resistant Depression appearing as the primary indexed condition, and to 1 intervention - of which Prefrontal Cortical Stimulation (PCS) is the first listed.
NCT04124341 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.
Frequently Asked Questions
What is clinical trial NCT04124341 about?
NCT04124341 is a clinical study titled "PCS in Severe Treatment Resistant Depression". 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 fibrou...
What is the current status of trial NCT04124341?
This trial is currently recruiting. It is a NA study. The enrollment target is 15 participants. The study started on 2021-09-29. Estimated completion is 2032-12-31.
What conditions does trial NCT04124341 study?
This clinical trial studies the following conditions: Treatment-Resistant Depression.
What interventions are being tested in trial NCT04124341?
The interventions under investigation include: Prefrontal Cortical Stimulation (PCS) (DEVICE).
Who is sponsoring clinical trial NCT04124341?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04124341 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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