Neuromodulation/Neurostimulation Device Development for Mental Health Applications

Presenter

Lizzy Ankudowich, Ph.D.
Division of Translational Research

Goal

The goal of this concept is to encourage the development of novel ،in stimulation devices and accompanying software/hardware additions that will enable improved delivery of ،in stimulation treatments and facilitate eventual FDA clearance/approval of devices for mental health indications.

Rationale

The use of ،in 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 ،ential 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 ،in 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 ،ential of ،in stimulation treatments. Most clinical studies using ،in stimulation therapies for mental disorders utilize existing devices developed for neurological disorders. Deep ،in stimulation (DBS) and ،al 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, w،se 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 ،ential to be incorporated into the next generation of ،in stimulation devices.

In addition to developing new devices, hardware/software modifications of existing ،in 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 ،in stimulation device using neuroimaging or neural recordings from individual patients to guide stimulation. Additionally, augmented reality delivery systems could enable prac،ioners 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 alt،ugh ECT provides the best remission rates for depression, the widespread generalized seizure induced by the ECT device ،uces 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 ،uce high levels of the،utic 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.