Clinical Trials Logo

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 (Abbott Laboratories) for stimulation. Although the U.S. Food and Drug Administration (FDA) has approved the 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 (confirm target engagement and demonstrate clinical relevance): To assess the impact of PCS on Late Positive Potential (LPP), which reliably captures biased attention and early affective responses to environmental stimuli. To examine the relationship between changes in LPP and clinical improvement. ;


Study Design


Related Conditions & MeSH terms


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

See also
  Status Clinical Trial Phase
Recruiting NCT03887715 - A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression N/A
Completed NCT04727229 - Stellate Ganglion Block for Major Depressive Disorder. Phase 4
Completed NCT04634669 - Open-Label Safety Study of AXS-05 in Subjects With TRD (EVOLVE) Phase 2
Not yet recruiting NCT05921929 - First-In-Human (FIH), Single Ascending Dose (SAD) Study of FluoroEthylNorMemantine (FENM) Phase 1
Withdrawn NCT03175887 - Investigational TMS Treatment for Depression N/A
Completed NCT03134066 - Neurocognitive Features of Patients With Treatment-Resistant Depression
Active, not recruiting NCT01984710 - Deep Brain Stimulation for Treatment Resistant Depression With the Medtronic Activa PC+S N/A
Completed NCT01935115 - Comparing Ketamine and Propofol Anesthesia for Electroconvulsive Therapy Phase 4
Terminated NCT01687478 - A Study of Olanzapine and Fluoxetine for Treatment-resistant Depression Phase 3
Completed NCT00531726 - Berlin Deep Brain Stimulation Depression Study N/A
Recruiting NCT05870540 - BPL-003 Efficacy and Safety in Treatment Resistant Depression Phase 2
Recruiting NCT04041479 - Biomarker-guided rTMS for Treatment Resistant Depression Phase 3
Recruiting NCT04959253 - Psilocybin in Depression Resistant to Standard Treatments Phase 2
Completed NCT04856124 - Intranasal Esketamine to Maintain the Antidepressant Response to IV Racemic Ketamine
Recruiting NCT03272698 - ECT With Ketamine Anesthesia vs High Intensity Ketamine With ECT Rescue for Treatment-Resistant Depression Phase 4
Active, not recruiting NCT04451135 - CET- REM (Correlating ECT Response to EEG Markers) N/A
Completed NCT03288675 - Stepped Care aiTBS 2 Depression Study (Ghent) N/A
Recruiting NCT06138691 - KET-RO Plus RO DBT for Treatment Resistant Depression Phase 1
Terminated NCT02675556 - Allogeneic Human Mesenchymal Stem Cells (hMSCs) Infusion in Patients With Treatment Resistant Depression Phase 1
Recruiting NCT03952962 - Tractography Guided Subcallosal Cingulate Deep Brain Stimulation for Treatment Resistant Depression N/A