Study of Combo-stim Deep Brain Stimulation for Adults with Treatment-Resistant Mental Disorders Including OCD, Schizophrenia, Bipolar Depression, Anorexia, Gambling Disorder, and Adult Autism

What this Trial Is About

Researchers are evaluating the effectiveness and safety of a device called combo-stim deep brain stimulation DBS in adults with several treatment-resistant mental disorders including obsessive-compulsive disorder, schizophrenia, bipolar disorder with depression, anorexia nervosa, gambling disorder, and adult autism. This multi-center, single-arm, prospective, open-label study aims to understand how DBS affects these conditions by stimulating specific brain areas. The study involves 18 participants from Shanghai Mental Health Center who meet strict eligibility criteria. Participants will undergo neurosurgical implantation of DBS electrodes into two brain areas the bilateral nucleus accumbens and the anterior limb of the internal capsule. The DBS system will be activated and adjusted 7 to 14 days after implantation. Treatment effects will be evaluated after 8 to 24 weeks of stimulation. The study is extendable, with participants able to continue long-term follow-up assessments beyond 24 weeks based on their specific mental disorder. During the study, participants will have multiple evaluations including physical exams, vital signs, laboratory tests, electrocardiograms, imaging scans, and standardized psychiatric rating scales like the Yale-Brown Obsessive-Compulsive Scale, PANSS, MADRS, BMI, and Autism Behavior Checklist. Researchers will monitor safety by tracking adverse events, device performance, and any serious complications. The primary outcomes focus on symptom changes after 12 weeks of stimulation, with additional measures assessed up to 24 weeks. The total duration of involvement varies depending on the participants condition and agreement to extension.

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