Safety and Feasibility of DBS for Bipolar Depression

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-70
SponsorIcahn School of Medicine at Mount Sinai

About this trial

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.

Eligibility criteria

Qualifiers

Age 22-70 years

Ability to provide written informed consent

Primary diagnosis of Bipolar I Disorder confirmed by SCID-5

Current major depressive episode (MDE) of at least 12 months duration

Disqualifiers

Current manic or hypomanic episode (YMRS ≥12)

Rapid cycling pattern (≥4 mood episodes in the past 12 months)

Active suicidal ideation with intent or plan

Suicide attempt within six months prior to baseline

Trial design

Treatments tested in this trial

  • Medtronic Percept PC DBS system

Treatment groups

5 Participants
are divided into 1 treatment group