DBS for Depression

Part of paid clinical trials in Dallas, Texas.

Sponsor
Baylor College of Medicine
Study ID
NCT03437928
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
22 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Directional Deep Brain Stimulation — DEVICE
    Boston Scientific Vercise DBS leads and 16-channel implanted pulse generators (IPGs) will be implanted to control the shape and size of stimulation

Study Details

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

Key Dates

Start date
Aug 20, 2019
Status verified
May 2025
Primary completion
Aug 19, 2026
Completion
Aug 19, 2026

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Directional Deep Brain Stimulation

Primary Outcome Measure

Changes in depressive symptoms [ Time Frame: 54 to 60 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Texas SouthwesternDallasTexas75390
Nader Pouratian, MD
[email protected]
214-648-9323
Hamasa Ebadi
[email protected]
571-265-5926
Baylor College of MedicineHoustonTexas77030-

Find similar trials in Dallas, TX

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
University of Texas Southwestern· Dallas, TXBaylor College of Medicine· Houston, TX

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