New York City’s Mount Sinai has become the first hospital in the US to perform a deep brain stimulation (DBS) implantation procedure to address treatment-resistant depression (TRD).
The procedure was undertaken as part of Abbott’s pivotal multi-site, randomised TRANSCEND trial investigating the DBS system for TRD. Mount Sinai is one of 25 locations across the US that will be involved in Abbott’s trial, which is expected to enrol between five and 10 patients.
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After completing 12 months in the study, all participants, irrespective of whether they were in the treatment or control arm, will have their DBS system turned on and be followed for two years.
Abbott received a breakthrough device designation from the US Food and Drug Administration (FDA) to investigate the use of its DBS system for TRD in 2022.
According to Dr Brian Kopell, director of the Center for Neuromodulation at Mount Sinai West and principal investigator of the trial, there currently exists a schism between what is considered ‘psychiatric’ and what is ‘neurological’ in the lay community and even among many clinicians.
“Advances in neuroscience, however, have made it clear that these ‘psychiatric diseases’ are indeed similar to other neurological conditions – we can see identifiable structural and functional changes in the brain,” said Kopell.
“Therefore, it’s not surprising that DBS research thus far has demonstrated promise for people with TRD. We are thrilled to kick off Abbott’s TRANSCEND trial here at Mount Sinai with this first patient case and are eager to help gather further evidence about the impact this experimental treatment could have for patients with TRD.”
DBS potential
Research indicates that TRD, in which a person’s depression symptoms persist despite taking antidepressants as directed, affects up to 2.8 million US adults annually.
Dr Helen Mayberg, founding director of the Nash Family Center for Advanced Circuit Therapeutics at Mount Sinai has studied DBS for over 20 years and is credited with identifying the subcallosal cingulate as a signalling hub for depression in the brain and discovering that modulation of the brain region can help alleviate the symptoms of depression.
In DBS for TRD, an electrode on a wire is inserted through an opening in the skull until the tip reaches a targeted spot deep in the brain that has been informed by preoperative advanced imaging techniques. The wire is subsequently connected to a neurostimulator device implanted under the skin to enable electrical current to be sent, as necessary, to disrupt electrical activity in the brain to help alleviate TRD symptoms.
While not currently approved for TRD, the FDA has approved DBS treatment for conditions including obsessive-compulsive disorder, a device for which the agency approved under a humanitarian device exemption (HDE) in 2009, and Parkinson’s disease. In 2024, Abbott’s Liberta RC DBS system for treating the symptoms of Parkinson’s received FDA approval.
DBS treatment is currently undergoing an evolution with the rise of adaptive DBS (aDBS). Last month, Medtronic received FDA approval for BrainSense, the first aDBS system approved by the agency for Parkinson’s disease following the system’s receipt of a CE mark in Europe in January.
Other companies developing aDBS systems include Newronika which completed a €13.6m ($14.1m) Series B funding round last month to advance the development of its AlphaDBS aDBS system for Parkinson’s disease.
A GlobalData report forecasts that the global neurological devices market will reach a valuation of $20.9bn by 2033, up from $12.5bn in 2023.
