Ignite Creation Date:
2024-05-05 @ 10:22 PM
Last Modification Date:
2024-10-26 @ 10:18 AM
Study NCT ID:
NCT01095263
Status:
COMPLETED
Last Update Posted:
2018-08-06
First Post:
2010-03-24
Brief Title:
Effects of Deep Brain Stimulation in Treatment Resistant Major Depression
Sponsor:
University Hospital Bonn
Organization:
University Hospital Bonn
Study Overview
Official Title:
Assessment of Efficacy Safety and Effects on Quality of Life of Deep Brain Stimulation to the Medial Forebrain Bundle in Patients With Treatment Resistant Major Depression FORESEE FOREbrain Stimulation dEprEssion
Status:
COMPLETED
Status Verified Date:
2018-08
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:
FORESEE
Brief Summary:
The investigators will investigate in a sham controlled design antidepressant effects and safety of DBS to the superolateral branch of the main medial forebrain bundle slMFB
Detailed Description:
The target point for DBS in major depression disorder is located lateral to the ventral tegmental area VTA in the midbrain at the branching point of the superolateral branch slMFB from the main medial forebrain bundle MFB
The exact stimulation coordinates are
MNI152 coordinates
left xlat-5 yap-14 zvert-8 right xlat5 yap-14 zvert-9
MCP coordinates
eft xlat-6 yap-1 zvert-6 right xlat4 yap-1 zvert-7
All coordinates refer to the MNI152 brain Legend slMFB superolateral branch of medial forebrain bundle MNI152Montreal Neurologic Institute brain 152 coordinates MCP mid-commissural point coordinates lat lateral ap antero-posterior vert vertical
More information can be found at httpgoogln9sWV
In addition to the described intervention we will record EEG activity within the implanted regions during cognitive paradigms Fell and Axmacher Nat Rev Neurosci 2011 Specifically we will investigate the neural mechanisms underlying classification learning working memory and exploration of rewarded spatial locations and explore oscillatory responses following stimulation of the target regions These experimental paradigms will be conducted on the first day after electrode implantation
The exact stimulation coordinates are
MNI152 coordinates
left xlat-5 yap-14 zvert-8 right xlat5 yap-14 zvert-9
MCP coordinates
eft xlat-6 yap-1 zvert-6 right xlat4 yap-1 zvert-7
All coordinates refer to the MNI152 brain Legend slMFB superolateral branch of medial forebrain bundle MNI152Montreal Neurologic Institute brain 152 coordinates MCP mid-commissural point coordinates lat lateral ap antero-posterior vert vertical
More information can be found at httpgoogln9sWV
In addition to the described intervention we will record EEG activity within the implanted regions during cognitive paradigms Fell and Axmacher Nat Rev Neurosci 2011 Specifically we will investigate the neural mechanisms underlying classification learning working memory and exploration of rewarded spatial locations and explore oscillatory responses following stimulation of the target regions These experimental paradigms will be conducted on the first day after electrode implantation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None