Tractography Guided Subcallosal Cingulate Deep Brain Stimulation for Treatment Resistant Depression

Part of paid clinical trials in Dallas, Texas.

Sponsor
Nader Pouratian
Study ID
NCT03952962
Status
Recruiting
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Conditions

  • Treatment Resistant Depression
  • Undergoing Deep Brain Stimulation (DBS) Surgery

Eligibility Criteria

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

Interventions

  • Abbott Laboratories Infinity™ implantable deep brain stimulation system — DEVICE
    Deep brain stimulation (DBS) refers to the process of delivering an electrical current to a precise location in the brain.

Study Details

Treatment resistant depression remains a major problem for individuals and society. Surgical procedures may provide relief for some of these patients. The most frequently considered surgical approach is deep brain stimulation (DBS) of a part of the brain called the subcallosal cingulate region. However, the effectiveness and safety is not well established. The investigators will use a novel approach using advanced imaging technique (magnetic resonance tractography) to evaluate the feasibility and safety of this surgical approach. An innovative method for the definition of DBS target will be applied that redefines the concept of targeting as one of targeting a symptomatic network rather than a structural brain region using subject-based brain anatomy to define the target location. The correlation between imaging findings at baseline with the mood score changes at different time points of the study will be investigated.

Key Dates

Start date
Oct 28, 2022
Status verified
Jun 2025
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
12 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: Randomized Discontinuation Period: OFF then ON DBS
    Subjects randomized to this arm are initially "OFF" DBS after the open label period then gradually decreased in their optimized setting's amplitude for 8 weeks and then "ON" DBS for 8 weeks.
  • Experimental: Randomized Discontinuation Period: ON then OFF DBS
    Subjects randomized to this arm are initially "ON" DBS with optimized stimulation settings for 8 weeks after the open label period and then "OFF" DBS with gradually decreasing amplitude for 8 weeks.

Primary Outcome Measure

Change in Montgomery and Asberg Depression Rating Scale (MADRS) score. [ Time Frame: 18 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UT Southwestern Medical CenterDallasTexas75390
Nader Pouratian, MD, PhD
[email protected]
310-274-2095

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By research site
UT Southwestern Medical Center· Dallas, TX

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