Efficacy and Safety of Combo-stim Deep Brain Stimulation for Treatment-refractory Mental Disorders

Total of 18 subjects from Shanghai Mental Health Center who fit inclusion and don't fit exclusion criteria are recruited to undergo neurosurgical implantation of combo-stim DBS in bilateral nucleus accumbens (NAcc) and anterior limb of internal capsule (ALIC) on a certain date, the DBS system will be turned on for stimulation and parameters adjusted 7-14 days after implantation, treatment purposes are evaluated after system has been turned on for 8-24 weeks. Primary efficacy is evaluated by change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS), Positive and Negative Syndrome (PANSS), Montgomery-Asberg Depression Rating Scale (MADRS), Body Mass Index (BMI), Autism Behavior Checklist (AuBC) score and longest consecutive days without gambling within one month. Safety is evaluated by adverse events (AE) and device-related adverse events (ADE), serious adverse events (SAE) and serious device-related events (SADE), device deficiencies (DD) and device malfunction, physical examination and vital signs, laboratory examination, electrocardiogram (ECG), imaging examination, scale evaluation and early drop out ratio due to AE. Recruitment Progress Update (As of August 2026) This ongoing study has completed a total of 16 screenings and enrolled 15 participants. Detailed recruitment and safety status by indication is presented below: 1. Obsessive-Compulsive Disorder (OCD) A total of 5 participants were screened, 4 participants were enrolled, and 1 participant failed screening. All 4 enrolled participants have completed study discontinuation. 2. Bipolar Disorder A total of 6 participants were screened and all 6 participants were successfully enrolled with no screening failure. Among the enrolled participants, 5 participants have discontinued from the study, and 1 serious adverse event (SAE) has been reported in this subgroup. 3. Schizophrenia Spectrum Disorder A total of 3 participants were screened and enrolled, with no screening failure. Two participants have discontinued from the study. 4. Autism Spectrum Disorder A total of 2 participants were screened and enrolled, with no screening failure. Both enrolled participants have completed study discontinuation. Study recruitment is currently ongoing.