Deep Brain Stimulation for Depression
(TRANSCEND Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new method called Deep Brain Stimulation (DBS) to treat non-psychotic unipolar Major Depressive Disorder (MDD), a type of depression without hallucinations or delusions. Researchers aim to determine if stimulating a specific brain area can safely reduce symptoms of long-term, treatment-resistant depression. Participants will either have the DBS device activated shortly after implantation or wait a year before activation. Suitable candidates have been diagnosed with MDD, have not found relief after trying at least four different antidepressants, and have experienced a major depressive episode for a year or more. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for those who have not found relief through traditional methods.
Will I have to stop taking my current medications?
The trial requires that your depression medication and treatment regimen be stable for at least 4 weeks before the first baseline visit, so you may need to continue your current medications without changes during that time.
What prior data suggests that this technique is safe for treating Major Depressive Disorder?
Research has shown that deep brain stimulation (DBS) is generally safe when doctors carefully select the right patients. In past studies, many patients experienced significant improvements in their conditions after undergoing DBS. However, like any surgery, it carries risks. These risks can include incorrect wire placement, brain bleeding, stroke, infection, and breathing problems. Despite these risks, DBS is considered a low-risk procedure and often provides long-term benefits. Participants should discuss these potential risks with their healthcare team when considering joining a trial.12345
Why are researchers excited about this trial?
Researchers are excited about Deep Brain Stimulation (DBS) for treatment-resistant depression because it offers a novel approach by directly targeting the brain's subcallosal cingulate network. Unlike traditional treatments like antidepressants and psychotherapy, which can take weeks or months to show results, DBS has the potential to provide quicker relief by electrically modulating specific brain circuits involved in mood regulation. This method is particularly promising for individuals who haven't responded to other treatments, as it bypasses the need for systemic drug administration and directly influences brain activity, offering hope for a more effective intervention.
What evidence suggests that this trial's treatments could be effective for Major Depressive Disorder?
This trial will compare two groups to evaluate the effectiveness of Deep Brain Stimulation (DBS) for treating depression. The active-stimulation group will have the DBS system activated two weeks after implantation, while the sham-stimulation group will have the device implanted but not activated for the first 12 months. Research has shown that DBS might be a promising treatment for depression. DBS has helped individuals with Parkinson's Disease for many years. Although most research focuses on other conditions, DBS targets brain areas that control mood, suggesting it could help treat Major Depressive Disorder (MDD). Early results indicate that DBS might reduce symptoms in individuals unresponsive to other treatments. More research is needed, but the initial findings are hopeful.26789
Who Is on the Research Team?
Mark George, MD
Principal Investigator
Medical University of South Carolina
Brian Kopell, MD
Principal Investigator
MOUNT SINAI HOSPITAL
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either active or sham DBS therapy for 12 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension
Participants in the control arm receive active DBS therapy after unblinding
What Are the Treatments Tested in This Trial?
Interventions
- Bilateral Stimulation of Subcallosal Cingulate White Matter (SCCwm) using Deep Brain Stimulation (DBS)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Abbott Medical Devices
Lead Sponsor
Dr. Etahn Korngold
Abbott Medical Devices
Chief Medical Officer
Medical training at Harvard Medical School and Massachusetts General Hospital
Robert B. Ford
Abbott Medical Devices
Chief Executive Officer since 2020
Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business