Efficacy of Deep Brain Stimulation(DBS) for Treatment-Resistant Depression(TRD)

At least 40-60% of people with major depressive disorders (MDD) continue to have symptoms after treatment. The pharmacology treatment cannot produce sustained antidepressant effects in 50% of patients with depression. Therefore, more effective therapeutic methods are urgently needed. In a comprehensive survey of diverse neuromodulation therapies, targeting specific nuclei with deep brain stimulation (DBS) has the most potential for Treatment-resistant Depression (TRD) with apparent symptoms. The stimulation targets of DBS for patients with obsessive-compulsive disorder include the ventral capsule/ventral striatum (VC/VS), Brodmann area 25/subcallosal cingulate (SCC), Anterior Limb of Internal Capsule (ALIC), inferior thalamic peduncle (ITP), nucleus accumbens (NAc), lateral habenula (LHb), and medial forebrain bundle (MFB). However, the DBS case reports are limited and lack high-quality, evidence-based medical evidence. So, this cohort study focuses on the effectiveness of DBS-targeted VC/VS, SCC, ALIC, ITP, NAc, LHb, MFB, or other unreported nuclei targets on TRD.

Another goal of this program is to study the neuronal activity of the VC/VS, SCC, ALIC, ITP, NAc, LHb, MFB, or other unreported nuclei targets, 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.

• Remission, and response rate at week 2, month 3, month 6, and month 12, revealed by Montgomery-Asberg Depression Rating Scale (MADRS) [Срок оценки: Baseline to week 2, month 3, month 6, and month 12]
• the change from baseline to 2 weeks, 3 months, 6 months, and 12 months in the Hamilton Anxiety Rating Scale (HAMA) total score. [Срок оценки: Baseline to week 2, month 3, month 6, and month 12]
• the changes of Hamilton Depression Rating Scale, 17 item (HAMD-17) scores and its subscales from baseline to 2 weeks, 3 months, 6 months, and 12 months. [Срок оценки: Baseline to week 2, month 3, month 6, and month 12]
• the change of Pittsburgh Sleep Quality Index (PSQI) from baseline to Week 2, Month 3, Month 6, and Month 12. [Срок оценки: Baseline to week 2, month 3, month 6, and month 12]
• the change from baseline to 2 weeks, 3 months, 6 months, and 12 months in Clinical Global Impression-Severity scale (CGI-S) [Срок оценки: Baseline to week 2, month 3, month 6, and month 12]
• the change of Clinical Global Impression-Improvement scale (CGI-I) at Week 2, Month 1, Month 3, Month 6, and Month 12. [Срок оценки: Baseline to week 2, month 3, month 6, and month 12]
• the change from baseline to Week 2, Month 3, Month 6, and Month 12 in EuroQol-5 Dimension-level Scale (EQ-5D-5L). [Срок оценки: Baseline to week 2, month 3, month 6, and month 12]
• the change from baseline to Week 2, Month 1, Month 3, Month 6, and Month 12 in Young Mania Rating Scale (YMRS). [Срок оценки: Baseline to week 2, month 3, month 6, and month 12]
• Safety as indicated by the number of Adverse Events at Week 2, Month 3, Month 6, and Month 12. [Срок оценки: Baseline to week 2, month 3, month 6, and month 12]
• the change from baseline to Month 12 in the Controlled Oral Word Association Test (COWAT). [Срок оценки: 1 year after neurostimulator implantation.]
• the change from baseline to Month 12 in the Trail-Making Test A&B [Срок оценки: 1 year after neurostimulator implantation.]
• the change from baseline to Month 12 in Rey-Osterrieth Complex Figure Test (ROCF). [Срок оценки: 1 year after neurostimulator implantation.]