Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06360991
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-11
First Post:
2024-04-08
Brief Title:
DBS for Treatment-resistant Obsessive-compulsive Disorder
Sponsor:
Xuanwu Hospital Beijing
Organization:
Xuanwu Hospital Beijing
Study Overview
Official Title:
The Effect of Deep Brain Stimulation DBS in Treatment-resistant Obsessive-compulsive Disorder TR-OCD
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
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:
None
Brief Summary:
The primary purpose of this study is to investigate the effect of deep brain stimulation DBS implantation targeting the anteromedial region of subthalamic nucleus amSTN or nucleus accumbens NAc or bed nucleus of the stria terminalis BNST or ventral capsuleventral striatum VCVS or the ventral anterior limb of the internal capsule vALIC in patients with treatment-resistant obsessive-compulsive disorder TR-OCD
Detailed Description:
At least 40-60 of people with obsessive-compulsive disorder OCD continue to have symptoms after drug treatment There is still a lack of effective therapies for TR-OCD In a comprehensive survey of diverse neuromodulation therapies targeting specific nuclei with DBS has the most potential for OCD with apparent symptoms The stimulation targets of DBS for patients with TR-OCD include vALIC BNST amSTN VCVS and NAc For the target site of each individual it depends on the individualized evaluation results made by the study team Although DBS is effective and tolerable and has the potential to improve the lives of many patients with TR-OCD evidence remains limited To explore its effectiveness this project plans to conduct DBS-targeted vALIC BNST amSTN VC VS or NAc on RT-OCD patients
Another goal of this program is to study the neuronal activity of the vALIC BNST amSTN VCVS and NAc 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 vALIC BNST amSTN VCVS and NAc 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?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None