Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06628752
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-03
Brief Title:
Deep Brain Stimulation for Obsessive-compulsive Disorder
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Deep Brain Stimulation for the Treatment of Severe Obsessive-compulsive Disorder
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to evaluate the treatment method of deep brain stimulation DBS in patients diagnosed with severe and treatment-resistant obsessive-compulsive disorder OCD DBS will be administered into the brain area of the bed nucleus of stria terminalis BNST
The main research questions are
Does active DBS in BNST reduce OCD symptoms primary outcome
Does active DBS in BNST reduce anxiety or depressive symptoms and improve the level of daily function
The participants will be randomized to active or sham DBS in the BNST for six months and we will measure the outcomes before DBS surgery and six months post-surgery After the randomization phase the participants will enter an open-label phase and receive continuous DBS in BNST Yearly follow-ups will be conducted The outcomes will be measured through interviews using validated psychometric scales
The main research questions are
Does active DBS in BNST reduce OCD symptoms primary outcome
Does active DBS in BNST reduce anxiety or depressive symptoms and improve the level of daily function
The participants will be randomized to active or sham DBS in the BNST for six months and we will measure the outcomes before DBS surgery and six months post-surgery After the randomization phase the participants will enter an open-label phase and receive continuous DBS in BNST Yearly follow-ups will be conducted The outcomes will be measured through interviews using validated psychometric scales
Detailed Description:
None
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