SWITCH Trial: Early Feasibility Study of Stentrode BCI for Augmentative Communication

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7. Project Summary Multiple early feasibility trials in humans have demonstrated that implantable Brain-Computer Interfaces (BCIs) can enable people with severe paralysis to use neural signals to control remote and digital communication technologies, including messaging and email. Such studies have demonstrated clearly that BCIs have the potential to improve the quality of life of patients who have physical disability due to paralysis of speech and upper limbs. However, until these technologies are commercialized, access to BCIs will remain limited to people involved in research studies, and only for the duration of their enrolment in the study. To address this unmet need, Synchron, Inc. has developed the StentrodeTM system, a fully implantable BCI that communicates wirelessly to an external interface on a mobile computing platform. The StentrodeTM BCI is a 16-channel array of sensors integrated into a self-expanding, stent-like substrate. The StentrodeTM is delivered endovascularly via a catheter to the Superior Sagittal Sinus, where it measures volitionally-modulated neural signals from the leg area of motor cortex in both hemispheres. A fully implantable, wireless telemetry unit digitizes and transmits the neural signals from the StentrodeTM to an external mobile processor that converts the neural signals into commands for operating a computer or other assistive device, such as a speller for communication. The Synchron team has already initiated a first-in-human trial of the StentrodeTM BCI system in Melbourne, Australia, under approvals granted by the Therapeutic Goods Administration (TGA) of Australia and the IRB of the Royal Melbourne Hospital. The first human implant was performed in a person with amyotrophic lateral sclerosis (ALS) in August, 2019. The participant has experienced no adverse events and is using the system to operate a computer and type messages to friends, family, and caregivers. The objective of the proposed research is to demonstrate in an Early Feasibility Study (EFS) that the StentrodeTM BCI communication system is safe and effective in providing a quantifiable improvement in independence and quality of life in n=6 people with severe paralysis due to ALS. Two Specific Aims are proposed: 1) Preclinical assessment of the StentrodeTM for safety and functionality to complete an FDA submission, and 2) Testing of StentrodeTM’s safety and efficacy in an EFS clinical trial in two centers of excellence in the USA. Under Aim 1 (UG3 phase), preclinical safety studies and software validation in large animal studies will be completed to test robustness of StentrodeTM, compliance to safety standards for Class III electromechanical implants, safety and baseline functionality in a large animal model, efficacy of custom-built software, and a functional neuroimaging study to support presurgical planning. Under Aim 2 (UH3 phase), an EFS study will test safety of StentrodeTM placement, monitoring adverse events, target patency, and device migration. When combined with eye-tracking technology, users will be trained to perform computer-based tasks using eye-gaze to control cursor position and BCI outputs to control discrete actions, such as letter or menu-item selection and zoom. Clinical efficacy outcomes will assess the restoration of independent function by use of personal devices, including technical capability (click and typing speed and accuracy, smart home, IoT, haptic feedback), independent domestic functionality (I-ADLs) and QOL and mental wellbeing (WHOQOL, MacGill QOL, HADS).