Presenter
Lizzy Ankudowich, Ph.D.
Division of Translational Research
Goal
The goal of this concept is to encourage the development of novel brain stimulation devices and accompanying software/hardware additions that will enable improved delivery of brain stimulation treatments and facilitate eventual FDA clearance/approval of devices for mental health indications.
Rationale
The use of brain stimulation devices provides a unique opportunity to develop novel treatments for mental disorders. Currently used devices include electroconvulsive therapy (ECT), which provides the most efficacious intervention for serious depression, and transcranial magnetic stimulation (TMS) which is a more recently cleared treatment for depression. However, while these successes demonstrate the potential to improve clinical care, limitations of the few FDA-approved/cleared devices (e.g., cognitive side effects of ECT, variability in response to TMS) hamper widespread clinical use. New brain stimulation devices and novel approaches with existing devices are urgently needed to develop efficacious treatments that will be widely utilized across various disorders.
New devices, developed with a focus on features unique to serious mental illnesses are needed to fully explore the potential of brain stimulation treatments. Most clinical studies using brain stimulation therapies for mental disorders utilize existing devices developed for neurological disorders. Deep brain stimulation (DBS) and vagal nerve stimulation (VNS) electrodes were developed for the treatment of Parkinson’s Disease and epilepsy. They have subsequently been studied, with minimal to no modification, for use in treating mental disorders, but there have been mixed results. New devices, whose development is informed by basic and clinical science findings in mental health research, may provide improved treatments for patients. For example, while current DBS electrodes are limited to one or two stimulation sites, neuroimaging studies have demonstrated the distributed, network-based nature of mental disorders. Therefore, distributed, multi-focal electrode arrays may be necessary to modulate networks back into a desired state. New forms of energy (e.g., ultrasound) also have the potential to be incorporated into the next generation of brain stimulation devices.
In addition to developing new devices, hardware/software modifications of existing brain stimulation devices can significantly enhance their capabilities and improve clinical care. An example of this approach includes the development of software capabilities that enable us to “close the loop” with a brain stimulation device using neuroimaging or neural recordings from individual patients to guide stimulation. Additionally, augmented reality delivery systems could enable practitioners to interactively target regions of interest with stimulation. Such approaches could improve the focality, depth, or closed-loop delivery of TMS and result in improved clinical response rates. And although ECT provides the best remission rates for depression, the widespread generalized seizure induced by the ECT device produces cognitive side effects that limit its use. Thus, the development of improved hardware/software capabilities that can deliver more focused stimulation, resulting in a smaller, controllable seizure, may produce high levels of therapeutic response while minimizing side effects. Across stimulation modalities, this critical device development research would serve as a foundational first step to first-in-human clinical studies and regulatory clearance.
