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

Major Depressive Disorder Clinical Trial

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

Status Recruiting

Clinical Trial 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

Clinical Trial Description

Treatment-resistant depression (TRD) is a major worldwide burden. Major depression has a lifetime prevalence of ~15% across developed countries. Up to a third of patients fail to respond adequately to evidence-based treatments, including pharmacological, behavioral, and electroconvulsive therapy. The investigators employ an innovative approach, including subacute invasive neurophysiological monitoring with which they aim to gain insight into the networks underlying depression symptomatology, confirm the ability to predict the effects of precision DBS on network activity, and harmonize these insights to implement network-guided DBS for TRD. ;

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

• NCT number: NCT03437928
• Study type: Interventional
• Source: Baylor College of Medicine
• Contact: Sameer A Sheth, MD, PhD
• Phone: 713-798-5060
• Email: sameer.sheth@bcm.edu
• Status: Recruiting
• Phase: N/A
• Start date: August 20, 2019
• Completion date: August 19, 2026