Abbott (NYSE: ABT) + announced today that it initiated a pivotal clinical trial evaluating its deep-brain stimulation (DBS) system in the treatment of depression.

The TRANSCEND study looks at DBS in the management of treatment-resistant depression (TRD), a form of major depressive disorder. Abbott won FDA breakthrough device designation to explore the use of DBS for TRD more than two years ago.

DBS works like a pacemaker in the brain. It’s a personalized, adjustable therapy that involves implanting thin wires (leads) into targeted areas of the brain. A pulse generator implanted under the skin in the chest connects to the leads and produces electrical impulses. These impulses can modulate abnormal brain activity.

Abbott previously said DBS systems traditionally helps control symptoms for people with movement disorders. Those include Parkinson’s disease and essential tremor. However, evidence suggests that implanting electrodes in the part of the brain that regulates mood could help reduce symptoms of TRD.

In the TRANSCEND study, Abbott aims for DBS to adjust activity in the brain to reduce symptoms associated with depression. Previous open-label studies demonstrated at least a 50% sustained improvement in those symptoms. This data came from three out of four people over a period of 2-8 years.

“Treatment-resistant depression is a debilitating condition affecting 2.8 million Americans each year,” said Pedro Malha, vice president, neuromodulation, Abbott. “The goal of Abbott’s TRANSCEND study, in collaboration with top clinical research centers, is to develop the clinical evidence necessary to determine whether DBS is a safe and effective treatment for Treatment Resistant Depression, which could provide people with a new treatment option that will allow them to live fuller lives.”