Ignite Creation Date:
2024-05-05 @ 6:52 PM
Last Modification Date:
2024-10-26 @ 9:38 AM
Study NCT ID:
NCT00565617
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-02
First Post:
2007-11-29
Brief Title:
Epidural Cortical Stimulation for Depression
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
A Pilot Safety and Efficacy Study of Epidural Prefrontal Cortical Stimulation EpCS in Severe Treatment Resistant Depression
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EpCS-D
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None