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DBS for Depression

NCT03437928 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-05-14

No results posted yet for this study

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

Conditions

Interventions

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

Sponsors & Collaborators

  • University of Texas

    collaborator OTHER

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Sameer A Sheth, MD, PhD · Baylor College of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-20
Primary Completion
2026-08-19
Completion
2026-08-19
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03437928 on ClinicalTrials.gov