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 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Treatment Resistant Depression||Device: Synergy, Epidural cortical stimulation||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|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|
|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 2020|
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
- 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
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
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29403|
|Principal Investigator:||Ziad Nahas, MD, MSCR||Medical University of South Carolina|