Safety and Feasibility of DBS for Bipolar Depression

Part of paid clinical trials in New York, New York.

Sponsor: Icahn School of Medicine at Mount Sinai
Study ID: NCT07745374
Status: Recruiting

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Conditions

Bipolar Depression
Bipolar I Disorder

Eligibility Criteria

Sex: ALL
Age: 22 Years - 70 Years
Healthy Volunteers: Not accepted

Interventions

Medtronic Percept PC DBS system — DEVICE
Open label active Deep Brain Stimulation (DBS) with continuous monitoring of local field potentials (LFP) from the SCC and amygdala.

Study Details

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.

Key Dates

First listed: Aug 4, 2026
Start date: Aug 31, 2026
Status verified: Aug 2026
Primary completion: Oct 31, 2028
Completion: Oct 31, 2028

Study Design

Enrollment: 5 participants (estimated)
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Arms

Experimental: Participants with Bipolar disorder
Participants with BPD will be treated with open label active bilateral Subcallosal Cingulate (SCC) Deep Brain Stimulation (DBS) with ongoing local field potential monitoring from the SCC and amygdala.