NCT03952962 · Nader Pouratian
Tractography Guided Subcallosal Cingulate Deep Brain Stimulation for Treatment Resistant Depression
What this study 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.
View original scientific description
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 participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Men and women (non-pregnant) between ages 21 and 70;
- DSM-5 diagnosis a current major depressive episode (MDE) for 10 years of less, recurrent or single episode with first episode after adulthood and did not start during childhood or adolescence, secondary to nonpsychotic unipolar major depressive disorder;
- Current index MDE ≥24 months duration and/or recurrent illness with at least a total of 2 lifetime episodes (including current episode \>12 months);
- Treatment resistance (defined by criteria on the Antidepressant Treatment History Form (ATHF)28): Failure to respond to a minimum of four adequate depression treatments from different categories;
- Symptom severity for Screening: Hamilton Depression Rating Scale-17 item (HDRS17) ≥20;
- Symptom severity for Outcome: Montgomery Asberg Rating Scale (MADRS) ≥27 to be met at assessment one week pre-op;
- Normal brain MRI within 3 months of surgery;
- Antidepressant medication regimen has been held stable for ≥ 30 days prior to the study screening MADRS;
- Remain on stable antidepressant medication throughout the study, unless there are safety concerns;
- Montreal Cognitive Assessment (MoCA) \>25;
- Able and willing to give informed consent and agree to attend regular clinic visits for at least 12 months.
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;
- Subjects who will be exposed to diathermy;
- Subjects who have any medical contraindications to undergoing DBS surgery (e.g. infection, coagulopathy, or significant cardiac or other medical risk factors for surgery);
- Subjects with another implanted device such as a cardiac pacemaker, defibrillator or neurostimulator;
- Subjects who have a history of hemorrhagic stroke;
- Subjects who are unable to undergo MRI;
- Subjects who are at increased risk of hemorrhage due to underlying medical conditions or medication.
Where
- Dallas, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 2, 2025 · Source of record for eligibility and locations