Epidural Cortical Stimulation for Depression

NCT00565617 | Active Not Recruiting Results DMC FDA Device

• 1 other identifier: HR - 16908
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: Chronic epidural cortical stimulation (ECS) involves the neurosurgical placement of an electric wire on the surface of the brain with intermittent activation. Over time, ECS modulates local and distal connected brain regions. It is being currently applied over the motor cortex to treat intractable pain. Because of the important role played by the medial prefrontal cortex in mood regulation, the goal of this study is to apply this minimally invasive neurostimulation modality over medial prefrontal cortex in severely ill depressed subjects who have failed all other attempts at treatment.

Conditions

Treatment Resistant Depression

Keywords

depression; epidural; cortical stimulation; brain stimulation; treatment-resistant; deep brain stimulation; TMS; DBS; ECS

Outcome Measures

Primary Outcomes (1)

• HDRS-24 Items

  Hamilton Depression Rating Scale (HDRS) is a standard, validated depression rating scale. It is a 24 item scale, but the primary score is based on the first 17 answers for a total score for depression. 0-7=Normal 8 - 13 = Mild Depression 14-18 = Moderate Depression 19 - 22 = Severe Depression \> 23 = Very Severe Depression

  7 months from baseline

Study Arms (1)

Synergy, Epidural cortical stimulation

EXPERIMENTAL

Epidural cortical stimulation (medial prefrontal cortex) for treatment resistant depression. The primary aim of this pilot study was to assess the feasibility and safety of EpCS in patients with treatment-resistant depression. Ultimately, for EpCS to be found effective, a much larger double blind placebo controlled study would be needed.

Device: Synergy, Epidural cortical stimulation

Interventions

Synergy, Epidural cortical stimulation DEVICE

Epidural cortical stimulation

Also known as: Epidural cortical stimulation

Synergy, Epidural cortical stimulation

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Subject has a diagnosis of chronic (≥ two years) or recurrent (multiple prior episodes) depression and is currently experiencing a major depressive episode without psychotic features as defined by DSM IV criteria.
• Subjects may have a diagnosis or unipolar or bipolar depressive episode.
• Subject has not had an adequate response to 4 or more adequate antidepressant treatments in the current depressive episode according to the Antidepressant Treatment History Form (ATHF) (Sackeim et al 1997).
• Subject must be between the ages of 21 and 80.
• Baseline HDRS 24-item ≥ 20 (both visits 1 week apart)
• Subject must be able to complete the evaluations needed for this study including the functional imaging scans.
• Subject must have had a history of one successful course of ECT in the past.
• Subject must provide written informed consent.
• Subject is stable on all antidepressant medication for at least 4 weeks before the baseline visit or not be taking antidepressant medication prior to entering the study.
• Subject must be able to remain on current medication schedule for the first 19 weeks of the study.
• Subject is not on a medication known to increase the risk of cortical stimulation-induced seizures. These include theophylline, stimulant medications, bupropion, or supraphysiological doses of thyroid supplements.
• The presence of any of the following will exclude a subject from the study:
• The EpCS would (in the investigator's judgment) pose an unacceptable surgical or medical risk for the patient (including, but not limited to: history of serious cardiac or pulmonary problems, stroke, significant brain malformation, progressive neurological disease, central nervous system disease or injury, history of seizure, previous neurosurgical procedure with suspected brain tissue scarring that would increase the risks for seizure or cervical fracture).
• Subject received general anesthetic within the last 30 days prior to enrollment (not including ECT procedure).
• Subject currently has another investigational device or cardiac pacemaker, implantable defibrillator, or other implantable stimulator

Sponsors & Collaborators

• Medtronic: collaborator
• Medical University of South Carolina: lead
• National Alliance for Research on Schizophrenia and Depression: collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29403, United States

Location

Related Publications (2)

• Nahas Z, Anderson BS, Borckardt J, Arana AB, George MS, Reeves ST, Takacs I. Bilateral epidural prefrontal cortical stimulation for treatment-resistant depression. Biol Psychiatry. 2010 Jan 15;67(2):101-9. doi: 10.1016/j.biopsych.2009.08.021.

  PMID: 19819427 RESULT

• Williams NR, Short EB, Hopkins T, Bentzley BS, Sahlem GL, Pannu J, Schmidt M, Borckardt JJ, Korte JE, George MS, Takacs I, Nahas Z. Five-Year Follow-Up of Bilateral Epidural Prefrontal Cortical Stimulation for Treatment-Resistant Depression. Brain Stimul. 2016 Nov-Dec;9(6):897-904. doi: 10.1016/j.brs.2016.06.054. Epub 2016 Jun 28.

  PMID: 27443912 RESULT

Related Links

• Brain Stimulation Service / Mood Disorders Program at MUSC
• NARSAD

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Gregory Sahlem
• Organization: Medical University of South Carolina

sahlem@musc.edu

843-792-5716

Study Officials

• Edward B Short, MD, MSCR

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Open Label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: We are currently monitoring participants that were implanted with Epidural Cortical Stimulators starting back in 2008. Primary investigation is completed, but they have implanted devices for investigational treatment of depression. We will keep the study open while they are monitored.

Study Record Dates

• First Submitted: November 29, 2007
• First Posted: November 30, 2007
• Study Start: October 1, 2007
• Primary Completion: December 1, 2009
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 13, 2026
• Results First Posted: September 18, 2017

Record last verified: 2026-04

Locations

US (1)