RecruitingNot ApplicableNCT07127913

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

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


Sponsor

Andrew Krystal

Enrollment

10 participants

Start Date

Jul 16, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 22 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a device implanted in the brain that delivers electrical stimulation only when it detects signs of depression — called closed-loop deep brain stimulation — in people with treatment-resistant bipolar depression. **You may be eligible if...** - You are between 22 and 70 years old - You have Bipolar II Disorder with a depressive episode lasting at least 1 year that has not responded to multiple treatments - You have not had a manic or hypomanic episode in the past 2 years - You are on a mood stabilizer or antipsychotic medication at a stable dose - You have tried and failed electroconvulsive therapy (ECT), or were unable to complete it - You are willing and able to have brain surgery and attend multiple research visits - You can speak and read English **You may NOT be eligible if...** - You have another major psychiatric disorder like PTSD, psychosis, panic disorder, or an eating disorder - You have active suicidal plans - You have had a suicide attempt requiring hospitalization in the past 2 years - You have a substance use disorder or metal implants incompatible with brain imaging Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEDevice: Stimulation-ON

Active neurostimulation from the NeuroPace RNS® System triggered by a biomarker

DEVICEDevice: Stimulation-OFF

No neurostimulation from the NeuroPace RNS® System

DEVICEDevice: 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

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NCT07127913


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