NCT06360991

DBS for Treatment-resistant Obsessive-compulsive Disorder

The Effect of Deep Brain Stimulation (DBS) in Treatment-resistant Obsessive-compulsive Disorder (TR-OCD)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Xuanwu Hospital, Beijing · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 capsule/ventral striatum (VC/VS), 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, VC/VS, 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, VC/VS, 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.

Conditions

• Obsessive-Compulsive Disorder (OCD)

Interventions

Type	Name	Description
DEVICE	Deep brain stimulation (DBS)	The DBS lead is stereotactically introduced into the target in the brain (vALIC, BNST, amSTN, VC/VS, or NAc) and fixed to the skull; the lead is then connected to a neurostimulator implanted subcutaneously in the subclavicular region.

Timeline

• Start date: 2024-04-20
• Primary completion: 2028-12-31
• Completion: 2029-12-31
• First posted: 2024-04-11
• Last updated: 2024-04-11

Locations

1 site across 1 country: China