Deep Brain Stimulation Surgery for Treatment Resistant Depression
Trial Summary
Will I have to stop taking my current medications?
The trial requires that you stay on your current antidepressant medication throughout the study, unless there are safety concerns.
What data supports the effectiveness of this treatment for treatment-resistant depression?
Is deep brain stimulation generally safe for humans?
Deep brain stimulation (DBS) has been used in various conditions like Parkinson's disease and treatment-resistant depression. While it can reduce symptoms, there are potential complications such as hardware failure and surgery-related issues. Safety data is limited, but some studies report complications related to the device and surgical procedure.16789
How is the Abbott Laboratories Infinity DBS System treatment different from other treatments for treatment-resistant depression?
The Abbott Laboratories Infinity DBS System is unique because it involves deep brain stimulation (DBS), a surgical procedure that uses electrical impulses to regulate brain circuits involved in depression. Unlike medications, DBS is adjustable and reversible, offering a novel approach for patients who do not respond to traditional treatments.23101112
What is the purpose of this trial?
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.
Research Team
Nader Pouratian
Principal Investigator
UT Southwestern Medical Center
Eligibility Criteria
This trial is for adults aged 21-70 with treatment-resistant depression, defined as not responding to at least four different types of antidepressant treatments. Participants must have a current major depressive episode lasting over 24 months or recurrent illness, and severe symptoms measured by specific scales. They should be on stable medication for at least one month before the study and able to attend regular clinic visits for a year.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Open-label Period
Participants receive open-label DBS to optimize stimulation settings
Randomized Discontinuation Period
Participants are randomized to either 'OFF then ON' or 'ON then OFF' DBS for 8 weeks each
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Abbott Laboratories Infinity™ implantable deep brain stimulation system
Abbott Laboratories Infinity™ implantable deep brain stimulation system is already approved in United States, European Union, Canada for the following indications:
- Essential tremor
- Parkinson's disease
- Dystonia
- Obsessive-compulsive disorder
- Epilepsy
- Essential tremor
- Parkinson's disease
- Dystonia
- Obsessive-compulsive disorder
- Epilepsy
- Essential tremor
- Parkinson's disease
- Dystonia
- Obsessive-compulsive disorder
- Epilepsy
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, Los Angeles
Lead Sponsor
Nader Pouratian
Lead Sponsor