Actively Recruiting
Tractography Guided Subcallosal Cingulate Deep Brain Stimulation for Treatment Resistant Depression
Led by Nader Pouratian · Updated on 2025-07-02
12
Participants Needed
1
Research Sites
243 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Tractography Guided Subcallosal Cingulate Deep Brain Stimulation for Treatment Resistant Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women (non-pregnant) between ages 21 and 70
- Diagnosis of current major depressive episode lasting 10 years or less, with recurrent or single episode starting in adulthood
- Current depressive episode lasting 24 months or more, or recurrent illness with at least two lifetime episodes
- Treatment resistance defined as failure to respond to at least four adequate depression treatments from different categories
- Hamilton Depression Rating Scale-17 item score of 20 or higher at screening
- Montgomery Asberg Depression Rating Scale score of 27 or higher one week before surgery
- Normal brain MRI within 3 months before surgery
- Stable antidepressant medication for at least 30 days before screening and throughout the study unless safety concerns arise
- Montreal Cognitive Assessment score above 25
- Able and willing to give informed consent and attend regular clinic visits for at least 12 months
You will not qualify if you...
- Any lifetime history of psychotic disorder or bipolar disorder
- Alcohol or substance use disorder within 6 months, excluding nicotine
- History of childhood physical or sexual abuse
- Personality disorders
- Seeking disability during the trial
- Substantial suicidal risk including plan, intent, or suicide attempt within last year
- No stable work history
- Medical or neurological conditions making surgery unsafe as judged by surgeon
- Pregnant or planning pregnancy within 36 months
- Unable or unwilling to use birth control during study period
- History of seizure disorder
- Exposure to diathermy
- Medical contraindications to DBS surgery such as infection, coagulopathy, or significant cardiac risk
- Presence of other implanted devices like pacemaker, defibrillator, or neurostimulator
- History of hemorrhagic stroke
- Unable to undergo MRI
- Increased risk of hemorrhage due to medical conditions or medications
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
Research Team
N
Nader Pouratian, MD, PhD
CONTACT
N
Nadia Imran
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
2
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