NCT07127913

Closed-Loop Deep Brain Stimulation for Treatment-Resistant Bipolar Depression

Closed-Loop Deep Brain Stimulation for Bipolar Depression (PReSiDio-BP)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Andrew Krystal · Academic / Other
• Sex: All
• Age: 22 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Neurons are specialized types of cells that are responsible for carrying out the functions of the brain. Neurons communicate with electrical signals. In diseases such as major depression this electrical communication can go awry. One way to change brain function is using electrical stimulation to help alter the communication between groups of neurons in the brain. The purpose of this study is to test a personalized approach to brain stimulation as an intervention for bipolar depression The study researchers will use a surgically implanted device to measure each individual's brain activity related to his/her depression. The researchers will then use small electrical impulses to alter that brain activity and measure whether these changes help reduce depression symptoms. This study is intended for patients with major depression whose symptoms have not been adequately treated with currently available therapies. The device used in this study is called the NeuroPace Responsive Neurostimulation (RNS) System. It is currently FDA approved to treat patients with epilepsy. The study will test whether personalized responsive neurostimulation can safely and effectively treat bipolar depression.

Detailed description

This is a single-center 3-stage feasibility study of personalized closed-loop stimulation for treatment resistant Bipolar Depression. Depending on participant's results at each stage, he/she might not be eligible to proceed to all 3 stages. Stage 1 of the study will involve surgically implanting small, thin electrodes in brain regions that regulate depression in order to identify personalized treatment sites. The researchers will test stimulation in the different brain regions and their effect on bipolar depression symptoms. The electrodes will be surgically removed at the end of Stage 1. Stage 2 will involve a second brain surgery to implant the NeuroPace RNS® System. Researchers will use information from Stage 1 to decide where to implant the electrodes of the RNS System. Over the next \~4-18 months, participants will have regular study visits in the clinic where the researchers will determine a personalized brain activity pattern that correlates with depression symptoms and can be paired with stimulation to improve depression symptoms. Stage 3 will be 36-40 weeks long and will involve turning ON and OFF the intervention to test its effectiveness. Participants will have a variable start time for Stage 3 to facilitate blinding of both patients and clinician raters. This variable time will be randomized from conditions of 0 days, 2 weeks, or 4 weeks (during which time participants will remain on optimized closed-loop stimulation). Each participant will have three 12-week periods: closed-loop stimulation (intervention), open-loop/fixed intermittent stimulation (active control), and sham (passive control), order counterbalanced. At the end of this stage the participant can choose to continue with long-term follow-up or have the RNS System surgically removed.

Conditions

• Bipolar II Disorder
• Bipolar II Disorder, Most Recent Episode Major Depressive

Interventions

Type	Name	Description
DEVICE	Device: Stimulation-ON	Active neurostimulation from the NeuroPace RNS® System triggered by a biomarker
DEVICE	Device: Stimulation-OFF	No neurostimulation from the NeuroPace RNS® System
DEVICE	Device: Stimulation -ON Active Control	Active neurostimulation from the NeuroPace RNS® System triggered with a fixed duty cycle

Timeline

• Start date: 2025-07-16
• Primary completion: 2030-06-28
• Completion: 2035-06-28
• First posted: 2025-08-17
• Last updated: 2025-08-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study