RecruitingNot ApplicableNCT03437928

DBS for Depression

Deep Brain Stimulation (DBS) for Depression Using Directional Current Steering and Individualized Network Targeting


Sponsor

Baylor College of Medicine

Enrollment

12 participants

Start Date

Aug 20, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of the study is to address the unmet need of TRD patients by identifying brain networks critical for treating depression and to use next generation precision DBS with steering capability to engage these targeted networks. The study's goal will be achieved through 3 specific aims: 1. Demonstrate device capability to selectively and predictably engage distinct brain networks 2. Delineate depression-relevant networks and demonstrate behavioral changes with network-targeted stimulation 3. Demonstrate that chronic DBS using steered, individualized targeting is feasible and safe for reducing depressive symptoms


Eligibility

Min Age: 22 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing deep brain stimulation (DBS) — a procedure where a small device is implanted to send electrical signals to specific areas of the brain — as a treatment for severe, treatment-resistant depression that has not responded to many other therapies. **You may be eligible if...** - You are between 22 and 70 years old and not pregnant - You have been diagnosed with major depressive disorder (MDD) as your primary condition - Your current depressive episode has lasted at least 24 months, or you have had at least 2 lifetime episodes including one lasting over 12 months - You have tried and failed multiple treatments including medications, psychotherapy, and electroconvulsive therapy (ECT) - You are otherwise medically healthy enough for surgery **You may NOT be eligible if...** - You have bipolar disorder, schizophrenia, or active substance abuse - You have a serious neurological condition or brain abnormalities - You have an unstable medical condition that would make surgery risky - You are unable to provide informed consent - You have a pacemaker or other implanted device that would conflict with DBS 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

DEVICEDirectional Deep Brain Stimulation

Boston Scientific Vercise DBS leads and 16-channel implanted pulse generators (IPGs) will be implanted to control the shape and size of stimulation


Locations(2)

University of Texas Southwestern

Dallas, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

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NCT03437928


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