RecruitingNot ApplicableNCT03952962

Tractography Guided Subcallosal Cingulate Deep Brain Stimulation for Treatment Resistant Depression


Sponsor

Nader Pouratian

Enrollment

12 participants

Start Date

Oct 28, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 21 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing deep brain stimulation (DBS) — a surgical procedure that places electrodes in a specific part of the brain — for people with severe, treatment-resistant depression that has not improved with multiple medications, therapy, or other treatments. The electrodes deliver small electrical pulses to regulate brain activity and improve mood. **You may be eligible if...** - You are between 21 and 70 years old - You have a confirmed diagnosis of major depressive disorder (MDD) that has lasted no more than 10 years - Your depression has not responded to at least 4 different types of antidepressant treatments - You first experienced depression as an adult (not in childhood) - You are not currently psychotic **You may NOT be eligible if...** - You have bipolar disorder or schizophrenia - You have active suicidal plans - You have had previous brain surgery - You have a pacemaker or other implanted device that could interfere with DBS - You are pregnant or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEAbbott Laboratories Infinity™ implantable deep brain stimulation system

Deep brain stimulation (DBS) refers to the process of delivering an electrical current to a precise location in the brain.


Locations(1)

UT Southwestern Medical Center

Dallas, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT03952962


Related Trials