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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

5 Participants
are divided into 1 treatment group
Group A: Participants with Bipolar disorderExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
Baseline and weekly up to 1 year

Secondary outcomes

1

Young Mania Rating Scale (YMRS)

Young Mania Rating Scale (YMRS) is an 11-item questionnaire to measure the severity of manic symptoms. 7 items are scored 0-4 and the other 4 items are scored 0-8. The overall YMRS score ranges from 0-60, with a higher score indicating more severe mania.

Time frame
Baseline and weekly up to 1 year

Other outcomes

Sponsors and contacts

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