Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : May 15, 2019
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 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
Enrollment 5
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Epidural Cortical Stimulation Device for Depression
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 6
Completed 5
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title Epidural Cortical Stimulation for Depression
Hide Arm/Group Description

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

Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
<=18 years
0
   0.0%
Between 18 and 65 years
5
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants
44.2  (9.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
4
  80.0%
Male
1
  20.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants
5
1.Primary Outcome
Title HDRS-24 Items
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Epidural Cortical Stimulation for Depression
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: units on a scale
Pre 28.4  (8)
7 months 13  (11.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Epidural Cortical Stimulation for Depression
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Epidural Cortical Stimulation for Depression
Hide Arm/Group Description

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.

All-Cause Mortality
Epidural Cortical Stimulation for Depression
Affected / at Risk (%)
Total   0/5 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Epidural Cortical Stimulation for Depression
Affected / at Risk (%)
Total   5/5 (100.00%) 
Infections and infestations   
Infection *  1/5 (20.00%) 
Psychiatric disorders   
Hospitalizations * [1]  5/5 (100.00%) 
*
Indicates events were collected by non-systematic assessment
[1]
All 5 participants did have hospitalizations for periods of worsening depression and suicidality or inability to care for self. They were all successfully stabilized inpatient and subsequently discharged. This was reported to the FDA. All stable now.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Epidural Cortical Stimulation for Depression
Affected / at Risk (%)
Total   0/5 (0.00%) 
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
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: May 15, 2019