Ignite Creation Date:
2024-05-06 @ 1:19 AM
Last Modification Date:
2024-10-26 @ 11:02 AM
Study NCT ID:
NCT01778790
Status:
COMPLETED
Last Update Posted:
2018-08-07
First Post:
2013-01-18
Brief Title:
Deep Brain Stimulation of the Superolateral Branch of the Medial Forebrain Bundle slMFB for the Treatment of Refractory 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 II 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:
FORESEEII
Brief Summary:
The investigators will investigate in a sham controlled staggered onset design antidepressant effects and safety of deep brain stimulation 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
Montreal Neurologic Institute brain 152 coordinates MNI152 coordinates
left xlat-5 yap-14 zvert-8 right xlat5 yap-14 zvert-9
Mid-commissural point coordinates 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 lat lateral ap anteroposterior vert vertical
More information can be found at httpgoogln9sWV
The exact stimulation coordinates are
Montreal Neurologic Institute brain 152 coordinates MNI152 coordinates
left xlat-5 yap-14 zvert-8 right xlat5 yap-14 zvert-9
Mid-commissural point coordinates 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 lat lateral ap anteroposterior vert vertical
More information can be found at httpgoogln9sWV
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