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Epidural Cortical Stimulation for Depression (EpCS-D)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00565617
Recruitment Status : Active, not recruiting
First Posted : November 30, 2007
Results First Posted : September 18, 2017
Last Update Posted : March 9, 2021
Sponsor:
Collaborators:
Medtronic
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
E. Baron Short, Medical University of South Carolina

Study Description
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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.

Condition or disease Intervention/treatment Phase
Treatment Resistant Depression Device: Synergy, Epidural cortical stimulation Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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
Primary Purpose: Treatment
Official Title: A Pilot Safety and Efficacy Study of Epidural Prefrontal Cortical Stimulation (EpCS) in Severe Treatment Resistant Depression
Study Start Date : October 2007
Actual Primary Completion Date : December 2009
Estimated Study Completion Date : December 2028

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Synergy, Epidural cortical stimulation
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
Epidural cortical stimulation
Other Name: Epidural cortical stimulation


Outcome Measures
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Primary Outcome Measures :
  1. HDRS-24 Items [ Time Frame: 7 months from baseline ]

    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



Eligibility Criteria
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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00565617


Locations
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United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29403
Sponsors and Collaborators
Medical University of South Carolina
Medtronic
National Alliance for Research on Schizophrenia and Depression
Investigators
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Principal Investigator: Ziad Nahas, MD, MSCR Medical University of South Carolina
More Information
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Additional Information:
NARSAD  This link exits the ClinicalTrials.gov site

Publications of Results:

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Responsible Party: E. Baron Short, Principal Investigator, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00565617    
Other Study ID Numbers: HR - 16908
First Posted: November 30, 2007    Key Record Dates
Results First Posted: September 18, 2017
Last Update Posted: March 9, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by E. Baron Short, Medical University of South Carolina:
depression
epidural
cortical stimulation
brain stimulation
treatment-resistant
 deep brain stimulation
TMS
DBS
ECS
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
 Behavioral Symptoms
Mood Disorders
Mental Disorders