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Epidural Cortical Stimulation for Depression (EpCS-D)

Primary Purpose

Treatment Resistant Depression

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Synergy, Epidural cortical stimulation
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Treatment Resistant Depression focused on measuring depression, epidural, cortical stimulation, brain stimulation, treatment-resistant, deep brain stimulation, TMS, DBS, ECS

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

To be eligible for this study, a subject must meet all the following inclusion and exclusion criteria:

  • 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.

Exclusion Criteria:

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
  • Subject on anticoagulant drugs, with low platelets counts or have PT or PTT abnormalities or other risk factors for intra-operative or post-operative bleeding
  • Subject is expected to require full body magnetic resonance imaging (MRI) during the clinical study.
  • Subject is judged by the investigator to be acutely suicidal (e.g. within the 30 days prior to the EpCS implant, the subject has made a suicide attempt or gesture or has made specific plans or preparation to commit suicide).
  • Subject has a history of schizophrenia, schizoaffective disorder, or other psychotic disorder, active substance abuse or dependence (with the exception to caffeine and nicotine abuse) or a current major depressive episode that includes psychotic features (commonly referred to as psychotic depression) according to the DSM IV criteria.
  • Subject with a diagnosis of dementia with a Mini-Mental State Exam (MMSE) ≤23.
  • Female subjects with a positive urine pregnancy test.
  • Subject with a positive urine drug screen or current alcohol or substance abuse other than nicotine and caffeine.

Sites / Locations

  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Synergy, Epidural cortical stimulation

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 29, 2007
Last Updated
April 1, 2023
Sponsor
Medical University of South Carolina
Collaborators
Medtronic, National Alliance for Research on Schizophrenia and Depression
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1. Study Identification

Unique Protocol Identification Number
NCT00565617
Brief Title
Epidural Cortical Stimulation for Depression
Acronym
EpCS-D
Official Title
A Pilot Safety and Efficacy Study of Epidural Prefrontal Cortical Stimulation (EpCS) in Severe Treatment Resistant Depression
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
Medtronic, National Alliance for Research on Schizophrenia and Depression

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Hypothesis: Severely Treatment Resistant Unipolar Depressed Subjects with EpCS of medial prefrontal cortex will show a significant decrease in depression symptoms at 6 months post-implant when compared to baseline and to a matched control group treated with electroconvulsive therapy (ECT). Method: We will enroll 5 subjects with severe refractory depression in an open trial with a 1 month placebo lead in, and for up to 1 years. We will also naturalistically follow 5 matched control patients treated with ECT. Depressive and cognitive symptoms will be rated periodically to assess the safety and efficacy of this procedure. Significance: This study takes advantage of the expertise at MUSC with various neuromodulation technologies to begin answering the crucial role of targeted cortical brain stimulation and its potential role in treatment resistant depression. This is a crucial pilot study that might lead to an entire new class of therapies for depression.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment Resistant Depression
Keywords
depression, epidural, cortical stimulation, brain stimulation, treatment-resistant, deep brain stimulation, TMS, DBS, ECS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Masking Description
Open Label
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Synergy, Epidural cortical stimulation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Synergy, Epidural cortical stimulation
Other Intervention Name(s)
Epidural cortical stimulation
Intervention Description
Epidural cortical stimulation
Primary Outcome Measure Information:
Title
HDRS-24 Items
Description
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
Time Frame
7 months from baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: To be eligible for this study, a subject must meet all the following inclusion and exclusion criteria: 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. Exclusion Criteria: 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 Subject on anticoagulant drugs, with low platelets counts or have PT or PTT abnormalities or other risk factors for intra-operative or post-operative bleeding Subject is expected to require full body magnetic resonance imaging (MRI) during the clinical study. Subject is judged by the investigator to be acutely suicidal (e.g. within the 30 days prior to the EpCS implant, the subject has made a suicide attempt or gesture or has made specific plans or preparation to commit suicide). Subject has a history of schizophrenia, schizoaffective disorder, or other psychotic disorder, active substance abuse or dependence (with the exception to caffeine and nicotine abuse) or a current major depressive episode that includes psychotic features (commonly referred to as psychotic depression) according to the DSM IV criteria. Subject with a diagnosis of dementia with a Mini-Mental State Exam (MMSE) ≤23. Female subjects with a positive urine pregnancy test. Subject with a positive urine drug screen or current alcohol or substance abuse other than nicotine and caffeine.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ziad Nahas, MD, MSCR
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29403
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
We are currently monitoring participants. Primary investigation is completed, but they have implanted devices for investigational treatment of depression. We will keep the study open while they are monitored.
Citations:
PubMed Identifier
19819427
Citation
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.
Results Reference
result
PubMed Identifier
27443912
Citation
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.
Results Reference
result
Links:
URL
http://www.narsad.org/
Description
NARSAD

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Epidural Cortical Stimulation for Depression

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