NCT03437928

DBS for Depression

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: All
• Age: 22 Years – 70 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DEVICE	Directional 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

Timeline

• Start date: 2019-08-20
• Primary completion: 2026-08-19
• Completion: 2026-08-19
• First posted: 2018-02-19
• Last updated: 2025-05-14

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study