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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:

Demonstrate device capability to selectively and predictably engage distinct brain networks Delineate depression-relevant networks and demonstrate behavioral changes with network-targeted stimulation 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03964194
Study type Interventional
Source Baylor College of Medicine
Contact Sameer A Sheth, MD, PhD
Phone 713-798-5060
Email sameer.sheth@bcm.edu
Status Not yet recruiting
Phase N/A
Start date August 1, 2019
Completion date September 30, 2024

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