RecruitingNot ApplicableNCT04004169

Closed-Loop Deep Brain Stimulation for Major Depression

Closed-Loop Deep Brain Stimulation for Treatment-Resistant Depression


Sponsor

Andrew Krystal

Enrollment

12 participants

Start Date

Jul 18, 2019

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 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 depression.


Eligibility

Min Age: 22 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a sophisticated form of deep brain stimulation (DBS) — a procedure that implants electrodes in the brain to deliver electrical signals — for people with severe, treatment-resistant major depression. Unlike standard DBS, this system adjusts stimulation in real time based on the patient's brain activity (closed-loop). **You may be eligible if...** - You are between 22 and 70 years old - You have a diagnosis of major depressive disorder (MDD) without psychosis - Your current episode has lasted at least 2 years - You have tried at least 4 adequate treatments (including electroconvulsive therapy, 3 classes of medications, augmentation strategies, and psychotherapy) without success - You have failed or been unable to tolerate electroconvulsive therapy (ECT) - You have a high depression score at screening (MADRS > 26) **You may NOT be eligible if...** - You have active suicidal intent with a specific plan - You have a primary diagnosis of another major psychiatric disorder - You have a history of certain neurological conditions - You are unable to complete required assessments 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

DEVICEStimulation-ON

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

DEVICEStimulation-OFF

No neurostimulation from the NeuroPace RNS® System

DEVICEStimulation-ON Active Control

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


Locations(1)

University of California, San Francisco

San Francisco, California, United States

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NCT04004169


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