Safety and Feasibility of DBS for Bipolar Depression

NCT07745374 | Recruiting DMC FDA Device

• 2 other identifiers: STUDY-26-00089DG251219
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar I Disorder; Bipolar Depression

Keywords

deep brain stimulation; safety; subcallosal cingulate; local field potentials; Bipolar 1 depression

Outcome Measures

Primary Outcomes (1)

• Hamilton Depression Rating Scale (HDRS)

  The Hamilton Depression Rating Scale (HDRS), is a 17-item questionnaire assessing severity of depression. Scores range from 0-50, with a higher score indicating more severe depression.

  Baseline and weekly up to 1 year

Secondary Outcomes (1)

• Young Mania Rating Scale (YMRS)

  Baseline and weekly up to 1 year

Study Arms (1)

Participants with Bipolar disorder

EXPERIMENTAL

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.

Device: Medtronic Percept PC DBS system

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.

Participants with Bipolar disorder

Eligibility Criteria

• Age: 22 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Current psychotic symptoms
• Primary diagnosis of schizophrenia, schizoaffective disorder, or other psychotic disorder
• History (current and/or lifetime) of one or more schizophrenia-spectrum or other psychotic disorders including: schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, and major depressive disorder with psychosis (unipolar or bipolar), and/or psychotic depression (unipolar or bipolar) (does not include psychosis occurring in the context of a manic episode of a subject with bipolar disorder)
• Substance use disorder (moderate or severe) within 6 months
• Presence of any type of dementia / Major Neurocognitive Disorder / significant cognitive impairment interfering with study participation
• Subject has had a prior VNS Therapy or deep brain stimulation (DBS) implant
• Subject has a diagnosis of Substance Use Disorder as defined by the DSM-V without sustained remission (12 months or longer)
• History of borderline or severe personality disorder, as determined by clinical judgment, which would significantly interfere with a subject's participation in the study
• Active primary diagnosis of one or more of the following disorders: obsessive-compulsive disorder, eating disorder, or post-traumatic stress disorder
• Cognitive or psychiatric deficit (e.g., amnesia, delirium) that in the investigator's judgment would interfere with the subject's ability to accurately complete study assessments
• Current or lifetime history of psychotic features in any major depressive episode (MDE)

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Center for Advanced Circuit Therapeutics, Clinical Neurosciences Center, Mount Sinai West

New York, New York, 10019, United States

RECRUITING

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• Helen Mayberg, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ellie Rapp

CONTACT

646-493-1607; ellie.rapp@mssm.edu

Avantika Vardhan

CONTACT

avantika.vardhan@mssm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Nash Family Center for Advanced Circuit Therapeutics; Professor, Neurology, Neurosurgery, Psychiatry and Neuroscience

Model Details: All participants will be implanted with two PERCEPT DBS devices and receive open label, active bilateral subcallosal cingulate (SCC) DBS with continuous monitoring of local field potentials (LFP) from the SCC and amygdala. Safety of SCC DBS to reduce depression symptoms without inducing mania will be assessed over 1 year.

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 4, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: August 4, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Beginning 9 months and ending 36 months following publication of findings.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose. To achieve aims in the approved proposal, physiology and imaging data will be housed at a URL to be created during the protocol. After publication the URL will be provided and investigators whose proposed use of the data has been approved will be provided with access.

Locations

US (1)