NCT06782867

RNS for Treatment-resistant Obsessive-compulsive Disorder

The Effect of Responsive Neurostimulation (RNS) in Treatment-resistant Obsessive-compulsive Disorder (TR-OCD)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Xuanwu Hospital, Beijing · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obsessive-Compulsive Disorder (OCD)

Interventions

Type	Name	Description
DEVICE	Responsive Neurostimulation (RNS)	The RNS lead is stereotactically introduced into the target in the brain and fixed to the skull; the lead is then connected to a neurostimulator implanted subcutaneously in the subclavicular region.

Timeline

• Start date: 2025-02-05
• Primary completion: 2028-12-31
• Completion: 2029-12-31
• First posted: 2025-01-20
• Last updated: 2025-01-20

Locations

1 site across 1 country: China