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Clinical Trial

Safety and Feasibility of DBS for Bipolar Depression

NCT: NCT07745374 · RECRUITING

NCT IDNCT07745374
StatusRECRUITING
Start Date2026-08
Completion2028-10
SponsorIcahn School of Medicine at Mount Sinai (OTHER)
First posted
Last updated

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.

Frequently Asked Questions

What is Safety and Feasibility of DBS for Bipolar Depression?

Safety and Feasibility of DBS for Bipolar Depression is a clinical trial registered under NCT07745374. Current status: RECRUITING.

What is the status of NCT07745374?

The current status of NCT07745374 (Safety and Feasibility of DBS for Bipolar Depression) is: RECRUITING.

When did Safety and Feasibility of DBS for Bipolar Depression start?

Safety and Feasibility of DBS for Bipolar Depression started on 2026-08.

Official Source

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Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.