The objective of this project is to demonstrate feasibility of a novel platform technology using ultrasonic waves for wireless bidirectional real-time communication and powering of a Bilateral Deep Brain Stimulation (DBS) system with remote patient monitoring. DBS has become an established neurosurgical procedure with over 160,000 patients treated worldwide. DBS has been shown to improve Parkinson's disease (PD) patient quality of life, increase long term tremor control, reduce dyskinesia, and reduce hyperdopaminergic behavioral symptoms. Some of the most common complications associated with this procedure are injury caused by wire/lead tunneling, erosions or infections of the tunneled wires, lead failure/migration, and tethering of extension cables. None of the current solutions are leadless and allow for remote monitoring due to limitations of wireless interconnected devices in the body. Bionet Sonar's software-defined UsWB proprietary technology is capable of transmitting energy and data via ultrasonic waves through tissue, bone, and fluids at penetration depths significantly higher than RF waves and with greater reliability. The Bionet platform includes: i) Reprogrammable wireless stimulation leads; ii) Rechargeable system controller to coordinate with, recharge, and reprogram other implantable elements of the network through the ultrasonic interface; iii) External recharging and communication patch to act as a power/data gateway to interconnect the intra-body network with the Internet. An intelligent DBS device that can be monitored by clinicians and provide feedback control to optimize therapy using remote continuous real-time data will lead to improved PD treatment options and informed treatment decisions individualized for each patient (point-of-care). In this Phase I study, feasibility for wireless power and remote monitoring with the Bionet system will be demonstrated by completing the following Specific Aims:
Specific Aim 1. Demonstrate in vitro feasibility of controlled deep brain stimulation, recharging and remote monitoring components using ultrasonic waves at typical implantable tissue depths.
Specific Aim 2. Demonstrate in vivo, data and energy transmission for the systems during controlled stimulation of the brain. In vivo experiments in minipig models (n=3) will be used to demonstrate the ability of the system to transmit data and energy from the subcutaneous controller to the pacing nodes using closed loop control based on real time electrical sensing. This proposal leverages the strengths of Bionet Sonar Inc. and the University of Louisville. Our long-term goal is to successfully translate the Bionet Sonar system into clinical practice. The core platform technology may also be applied to other networked systems for the treatment of diverse etiologies opening a new frontier in multimodal patient treatment and use of Artificial Intelligence for patient care.
Through this proposal a wireless remotely monitored deep brain stimulation system will be developed using new core technology for the Internet of Medical Things. Ultrasonic wideband technology will be used to enable wireless communication and recharging of the different implantable elements, allowing for miniaturization and energy efficiency. This technology will not only improve the outcomes and healthcare economics of the Parkinson's disease patient population, but may also enable other innovative therapies in other populations.