Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-01-01 @ 3:40 PM
Study NCT ID:
NCT06782867
Status:
RECRUITING
Last Update Posted:
2025-01-20
First Post:
2025-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RNS for Treatment-resistant Obsessive-compulsive Disorder
Sponsor:
Xuanwu Hospital, Beijing
Organization:
Study Overview
Official Title:
The Effect of Responsive Neurostimulation (RNS) in Treatment-resistant Obsessive-compulsive Disorder (TR-OCD)
Status:
RECRUITING
Status Verified Date:
2025-01
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 purpose of this study is to investigate the effect of personalized responsive neurostimulation (RNS) therapy guided by stereoelectroencephalography (SEEG) in patients with treatment-resistant obsessive-compulsive disorder (TR-OCD).
Detailed Description:
At least 40-60% of patients 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 personalized responsive neurostimulation (RNS) is the most promising treatment for OCD with apparent symptoms, but the evidence remains limited. The stimulation targets of RNS for patients with TR-OCD include vALIC, BNST, amSTN, VC/VS, and NAc. The efficacy of RNS in treating OCD is closely related to precise target localization. While stereoelectroencephalography (SEEG) brain mapping can help identify Individualized effective targets and stimulation parameters. This project plans to conduct SEEG-guided RNS on TR-OCD patients to assess the safety and initial efficacy.
Another goal of this study is to examine the neuronal activity of the vALIC, BNST, amSTN, VC/VS, and NAc, respectively. At the same time, some subjects are presented with a task involving an unexpected reward and various cognitive tasks. 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 study is to examine the neuronal activity of the vALIC, BNST, amSTN, VC/VS, and NAc, respectively. At the same time, some subjects are presented with a task involving an unexpected reward and various cognitive tasks. 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:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: