Deep Brain Stimulation for Bipolar Depression: Assessing the Safety and Use of Intracranial Neurophenotyping of State Switches
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.
• 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
• Stable control of mania for a minimum of 1 year
• Agreement to remain on current anti-mania medication regimen
• Hamilton Depression Rating Scale-17 (HDRS-17) score ≥20 at screening and baseline
• Young Mania Rating Scale (YMRS) score \<12 at screening and baseline
• Treatment-resistant depression: failure to respond to at least 4 adequate trials of antidepressant treatment in the current episode. Antidepressant treatments include: Medications (Must include 2 antidepressant medications from different pharmacological classes), Psychotherapy, ECT, repetitive transcranial magnetic stimulation (rTMS), IV ketamine or intra-nasal esketamine.
• All patients must be receiving at least one mood stabilizing medication at entry into the trial. Medication regimen must be stable for a minimum of 4 weeks before the baseline visit.
• Able to provide informed consent
• English-speaking
• Deemed suitable surgical candidate by neurosurgical evaluation
• Under care of treating psychiatrist willing to collaborate with study team
• Able to reside in New York Metropolitan area during first 6 months or willing/able to travel monthly to study site
• Provision of at least two emergency contacts age ≥22 residing within reasonable proximity