RNS for Treatment-resistant Obsessive-compulsive Disorder

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.

• Yale-Brown Obsessive Compulsive Scale (Y-BOCS): remission, response, and partial response rate [Срок оценки: Week 2, Month 1, Month 3, Month 6, and Month 12]
• Hamilton Anxiety Scale (HAMA): the change from baseline to 2 weeks, 1 month, 3 months, 6 months, and 1 year in the HAMA total score. [Срок оценки: Week 2, Month 1, Month 3, Month 6, and Month 12]
• Hamilton Depression Rating Scale (HAMD-17): the changes of HAMD-17 scores and its subscales from baseline to 2 weeks, 1 month, 3 months, 6 months, and 1 year. [Срок оценки: Week 2, Month 1, Month 3, Month 6, and Month 12]
• Pittsburgh Sleep Quality Index (PSQI): the change of PSQI from baseline to Week 2, Month 1, Month 3, Month 6, and Month 1. [Срок оценки: Week 2, Month 1, Month 3, Month 6, and Month 12]
• Clinical Global Impression-Severity (CGI-S): the change from baseline to 2 weeks, 1 month, 3 months, 6 months, and 1 year in Clinical Global Impression-Severity (CGI-S) [Срок оценки: Week 2, Month 1, Month 3, Month 6, and Month 12]
• Clinical Global Impression-Improvement (CGI-I): CGI-I score at Week 2, Month 1, Month 3, Month 6, and Month 12. [Срок оценки: Week 2, Month 1, Month 3, Month 6, and Month 12]
• EuroQol-5 Dimension-level Scale (EQ-5D-5L): the change from baseline to Week 2, Month 1, Month 3, Month 6, and Month 12 in EQ-5D-5L. [Срок оценки: Week 2, Month 1, Month 3, Month 6, and Month 12]
• Young Mania Rating Scale (YMRS): the change from baseline to Week 2, Month 1, Month 3, Month 6, and Month 12. [Срок оценки: Week 2, Month 1, Month 3, Month 6, and Month 12]
• Safety as indicated by the number of Adverse Events Week 2, Month 1, Month 3, Month 6, and Month 12. [Срок оценки: Week 2, Month 1, Month 3, Month 6, and Month 12]