Clinical Trial

Safety and Feasibility of DBS for Bipolar Depression

Recruiting
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Summary
This study addresses a critical unmet need in the treatment of bipolar disorder by investigating whether Subcallosal Cingulate (SCC) Deep Brain Stimulation (DBS) can safely and effectively treat treatment-resistant bipolar depression without inducing manic switches. The researchers propose to accomplish this by incorporating monitoring of the SCC local field potentials (LFP) for depression tracking and amygdala LFP monitoring for mania prediction while treating Bipolar I patients with SCC DBS Stimulation. This approach could establish a new paradigm for personalized neuromodulation therapy that uses real-time neural monitoring to optimize outcomes while minimizing risks. By incorporating bilateral, dual-site LFP monitoring from both the SCC and amygdala, this research will allow the researchers to assess the therapeutic efficacy of continuous SCC-DBS and develop novel safety biomarkers that could transform the clinical management of DBS therapy in psychiatry. The findings will have immediate implications for clinical practice and will advance the study team's fundamental understanding of the neural circuits underlying mood regulation and dysregulation in bipolar disorder.
Trial Details
NCT Number NCT07745374
Lead Sponsor Icahn School of Medicine at Mount Sinai
Conditions Bipolar I Disorder, Bipolar Depression
Enrollment 5 participants
Start Date 2026-08
Primary Completion 2028-10 (estimated)
Study Completion 2028-10 (estimated)
Updated on ClinicalTrials.gov 2026-08-04