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Deep Brain Stimulation (DBS) Therapy for Treatment Resistant Depression

NCT02046330 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2026-02-23

No results posted yet for this study

Summary

We propose a clinical study of medial forebrain bundle DBS as a treatment in 20 patients with treatment refractory depression (TRD). Data from the University of Bonn indicates that surgical lesions of the medical forebrain bundle can produce therapeutic benefits in patients with depressive disorders, and suggest that DBS at the same site may also reduce symptomatology in these TRD patients (Schaepfer, 2013). Depression affects up to 10% of the US population and of those at least 10-15% do not benefit from therapies hence why we must explore new treatments. The Percept™ PC system manufactured by Medtronic Neurological will be used in this study. Study subjects will be between the ages of 22 and 70 years of age and suffer from TRD, have failed multiple treatment regimens, including ECT, and remain symptomatic. Those identified as TRD patients will then be enrolled in a clinical pilot study investigating DBS, targeting the MFB.

Conditions

Interventions

DEVICE

Deep Brain Stimulation Model 3387 Model 3389

Implantation of all devices will be performed at a single session. Lead implantation will take place under local anesthesia, with implanted pulse generator (IPG) implantation under general anesthesia. The stereotaxic frame will be fitted on the day of surgery, following standard stereotactic surgical procedure. The leads will be inserted so that the stimulation sites span superolateral median forebrain bundle.

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Jair C Soares, MD, PhD · The University of Texas Health Science Center, Houston

  • Joao Quevedo, MD, PhD · The University of Texas Health Science Center, Houston

  • Giovana Zunta Soares, MD · The University of Texas Health Science Center, Houston

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
2013-12-16
Primary Completion
2027-04-01
Completion
2027-04-01

Countries

  • United States

Study Locations

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Diseases
Companies

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 NCT02046330 on ClinicalTrials.gov