🏛️ Verified NIH Record • Updated 2026-07-13

Tractography Guided Subcallosal Cingulate Deep Brain Stimulation for Treatment Resistant Depression (NCT03952962)

🟢 Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Nader Pouratian

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (11 items) and avoid the listed exclusions (18 items).

Location: UT Southwestern Medical Center — Dallas, Texas

Age range: 21 Years to 70 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • DSM-5 Axis I Disorders: any lifetime history of psychotic disorder or bipolar disorder;
  • Alcohol or substance use disorder within 6 months, excluding nicotine;
  • History of childhood abuse (physical or sexual) 18
  • Personality disorders;
  • Seeking disability during the trial;
  • Current substantial suicidal risk as defined by a plan or clear immediate intent for self-harm, or made any suicide attempt within the last year; (MADRS ≥ 5 including the day of surgery);
  • No stable work history;
  • Neurological/Medical condition that makes the patient, in the opinion of the surgeon, a poor candidate;
  • Pregnant or has plans to become pregnant in the next 36 months;
  • Unable/unable to practice birth control through the period of randomization and withdrawal of therapy;
  • Subjects who have a history of a seizure disorder;

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

  • UT Southwestern Medical Center — Dallas, Texas

📞 Contact the Study Coordinator

Phone: (310) 274-2095

Email: Nader.Pouratian@UTSouthwestern.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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Explore by condition: All Treatment Resistant Depression clinical trials

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗