Deep Brain Stimulation Therapy
Currently active and enrolling
The Abbott TRANSCEND study is a clinical study for people with depression who have been unable to find relief from their depression symptoms after trying at least four different antidepressant treatments. The study is currently enrolling at select study sites.
The TRANSCEND study is sponsored by Abbott and being conducted in the United States.
NCT06423430 l ClinicalTrials.gov
Caution – investigational device, limited by federal (or United States) law to investigational use.
The TRANSCEND (Treatment ResistAnt DepressioN Subcallosal CingulatE Network DBS) study is a prospective, multi-center clinical trial investigating whether deep brain stimulation (DBS) can help people with treatment-resistant depression (TRD).
The goal of the study is to evaluate the safety and effectiveness of deep brain stimulation as an investigational therapy to treat TRD, using the DBS system by Abbott. In the context of this clinical study, TRD is a type of depression where at least four different antidepressant treatments have been tried but did not work.
The TRANSCEND study will enroll approximately 100 adults, ages 22 to 70 who meet the study's eligibility criteria, across the United States. Since the study is designed as a double-blinded study, participants will be randomly assigned to one of two study groups.
Study participants will not know which group they have been assigned to until they are unblinded 12 months after their surgery. This study design will help researchers understand whether the therapy delivered by the DBS system is truly helping patients and, if so, how much.
All participants will be monitored throughout the length of the study. After the first 12 months, all patients will receive active stimulation through completion of the trial.
Deep brain stimulation (DBS) is a type of treatment for some movement disorders and involves surgically implanting a battery-operated system to send electrical signals to areas in the brain. These electrical signals can control (regulate) nerve signals to relieve symptoms.1
DBS has a long history of treating people with movement disorders.2 Abbott's DBS systems are approved for stimulation of the subthalamic nucleus (STN) or the internal globus pallidus (GPi) for Parkinson’s disease patients and stimulation of the ventral intermediate nucleus (VIM) of the thalamus for adult essential tremor patients. For the TRANSCEND study, Abbott's DBS system will also target a specific area in the brain - the subcallosal cingulate. Although DBS has been approved for some medical conditions, it is investigational for the use of treatment-resistant depression.
Abbott's DBS system is a neurostimulation system designed to deliver electrical pulses to targets in the brain. The DBS system has surgically implanted components: the implantable pulse generator (IPG), leads, and extensions.
The DBS system delivers electrical pulses to a selected target in the brain to provide therapeutic simulation.
The subcallosal cingulate (SCC) is an area in the brain and is being targeted in the TRANSCEND study. It is the first and most frequently researched target for depression.3 Deep brain stimulation of the SCC has been studied as a potential treatment for major depressive disorder since 2005.4 Neuroimaging and clinical studies have shown the SCC’s role in the antidepressant response to treatment. Overactivity of the SCC is common in TRD patients and affects behaviors that are altered in depression, such as motivation, memory and learning.5,6
To learn more about the Abbott TRANSCEND study, please contact a study center nearest you.
For media inquiries, please contact Carolina Castano (Carolina.castano@abbott.com).
For clinical inquiries, please contact Abbott Clinical Research (Neuro.clinical@Abbott.com).
The study is investigating if stimulating the subcallosal cingulate with small electrical pulses using the DBS System by Abbott is safe and beneficial when coupled with additional therapy for the treatment of depression.
If you are interested in learning more about the study, please reach out to Abbott Clinical Research (Neuro.clinical@abbott.com) for clinical inquiries. You can also reach out to the TRANSCEND study site for participation inquiries.
The DBS system by Abbott is approved by the U.S. FDA and other countries around the world for the treatment of various movement disorders, such as Parkinson’s disease and essential tremor. The same DBS system is being investigated for treatment of TRD in the TRANSCEND study.
Abbott's TRANSCEND study is being conducted under an investigational device exemption (IDE) from the FDA and will investigate the use of the DBS System for treatment-resistant depression (TRD).
DBS for TRD is currently an investigational therapy and is one type of neuromodulation for depression. Neuromodulation therapies for depression include surgical and nonsurgical procedures, such as repetitive transcranial magnetic stimulation (rTMS), electroconvulsive therapy (ECT) and vagus nerve stimulation (VNS).
CL1030016-A
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