Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06542900
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-01-29
Brief Title:
Efficacy of Deep Brain StimulationDBS for Treatment-Resistant DepressionTRD
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effectiveness and Safety of Deep Brain StimulationDBS in Treatment-Resistant DepressionTRD
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
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:
DBS for TRD
Brief Summary:
The primary purpose of this study is to investigate the effect of deep brain stimulation DBS implantation in patients with Treatment-resistant Depression TRD targeting the ventral capsuleventral striatum VCVS Brodmann area 25subcallosal cingulate SCC Anterior Limb of Internal Capsule ALIC inferior thalamic peduncle ITP nucleus accumbens NAc lateral habenula LHb medial forebrain bundle MFB or other unreported nuclei targets
Detailed Description:
At least 40-60 of people with major depressive disorders MDD continue to have symptoms after treatment The pharmacology treatment cannot produce sustained antidepressant effects in 50 of patients with depression Therefore more effective therapeutic methods are urgently needed In a comprehensive survey of diverse neuromodulation therapies targeting specific nuclei with deep brain stimulation DBS has the most potential for Treatment-resistant Depression TRD with apparent symptoms The stimulation targets of DBS for patients with obsessive-compulsive disorder include the ventral capsuleventral striatum VCVS Brodmann area 25subcallosal cingulate SCC Anterior Limb of Internal Capsule ALIC inferior thalamic peduncle ITP nucleus accumbens NAc lateral habenula LHb and medial forebrain bundle MFB However the DBS case reports are limited and lack high-quality evidence-based medical evidence So this cohort study focuses on the effectiveness of DBS-targeted VCVS SCC ALIC ITP NAc LHb MFB or other unreported nuclei targets on TRD
Another goal of this program is to study the neuronal activity of the VCVS SCC ALIC ITP NAc LHb MFB or other unreported nuclei targets respectively At the same time some subjects are presented with a task involving an unexpected reward This separate study is an option and will not affect current study participation
Some participants will also be invited to join a related study that involves positron emission tomography PET scanning to determine how the stimulation changes activity in the brain Participation in the separate PET study is optional and will not affect current study participation
Another goal of this program is to study the neuronal activity of the VCVS SCC ALIC ITP NAc LHb MFB or other unreported nuclei targets respectively At the same time some subjects are presented with a task involving an unexpected reward This separate study is an option and will not affect current study participation
Some participants will also be invited to join a related study that involves positron emission tomography PET scanning to determine how the stimulation changes activity in the brain Participation in the separate PET study is optional and will not affect current study participation
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