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RECRUITING
NCT07127913
NA

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

Sponsor: Andrew Krystal

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

22 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2025-07-16

Completion Date

2035-06-28

Last Updated

2025-08-17

Healthy Volunteers

No

Interventions

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

Locations (1)

University of California, San Francisco

San Francisco, California, United States