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Life sciences · Interventional Study
ClinicalTrials.gov · November 6, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07745374). This is a study registration, not published results. Lead sponsor: Icahn School of Medicine at Mount Sinai. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 5 participants (ESTIMATED). Conditions: Bipolar I Disorder, Bipolar Depression. Interventions: DEVICE: Medtronic Percept PC DBS system. Primary outcome measures: Hamilton Depression Rating Scale (HDRS) , Baseline and weekly up to 1 year. Brief 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.