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Epidural Cortical Stimulation for Depression (EpCS-D)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00565617
First Posted: November 30, 2007
Last Update Posted: September 18, 2017
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.
Collaborators:
Medtronic
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
E. Baron Short, Medical University of South Carolina
Results First Submitted: January 15, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Treatment Resistant Depression
Intervention: Device: Synergy, Epidural cortical stimulation

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Epidural Cortical Stimulation Device for Depression

Epidural cortical stimulation device (medial prefrontal cortex), implanted with leads bilaterally at Brodmanns area 10 and 46.

Synergy, Epidural cortical stimulation: Epidural cortical stimulation. Constant voltage device which can apply varying currents, pulsewidths, frequencies, and duty cycles.


Participant Flow:   Overall Study
    Epidural Cortical Stimulation Device for Depression
STARTED   6 
COMPLETED   5 
NOT COMPLETED   1 
Withdrawal by Subject                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Epidural Cortical Stimulation for Depression

Epidural cortical stimulation device (medial prefrontal cortex), implanted with leads bilaterally at Brodmanns area 10 and 46.

Synergy, Epidural cortical stimulation: Epidural cortical stimulation. Constant voltage device which can apply varying currents, pulsewidths, frequencies, and duty cycles.

For further description of arm please refer to published paper Ziad Nahas, Berry S. Anderson, Jeff Borckardt, Ashley B. Arana, Mark S. George, Scott T. Reeves, and Istvan Takacs "Bilateral Epidural Prefrontal Cortical Stimulation for Treatment- Resistant Depression" Biological Psychiatry. 2010


Baseline Measures
   Epidural Cortical Stimulation for Depression 
Overall Participants Analyzed 
[Units: Participants]
 5 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      5 100.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 44.2  (9.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      4  80.0% 
Male      1  20.0% 
Region of Enrollment 
[Units: Participants]
 
United States   5 


  Outcome Measures

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Gregory Sahlem
Organization: Medical University of South Carolina
phone: 843-792-5716
e-mail: sahlem@musc.edu


Publications of Results:

Responsible Party: E. Baron Short, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00565617     History of Changes
Other Study ID Numbers: HR - 16908
First Submitted: November 29, 2007
First Posted: November 30, 2007
Results First Submitted: January 15, 2016
Results First Posted: September 18, 2017
Last Update Posted: September 18, 2017