Innovation : Synchron’s Endovascular Brain Computer Interface (BCI) - Technology & First human trial
https://www.businesswire.com/news/home/20220719005248/en/Synchron-Announces-First-Human-U.S.-Brain-Computer-Interface-Implant
Introduction
Synchron’s flagship technology, the Stentrode, is an endovascular brain implant designed to enable patients to wirelessly control digital devices through thought and improve functional independence. Synchron’s foundational technology, a motor neuroprosthesis (MNP), or motor BCI, is implanted via the jugular vein. The system is designed for patients suffering from paralysis as a result of a range of conditions. It is designed to be user friendly and dependable for patients to use autonomously.
Technology
Synchron’s Endovascular BCI System consist of:
- stent covered with electrodes, implanted in superior sagittal sinus (SSS)
- connected with receiver implanted in subcutaneous pocket (like a pacemaker)
- connected by Bluetooth with external receiver
On July 2021 FDA approved Investigational Device Exception (IDE) application for the Stentrode BCI system – COMMAND trial.
COMMAND trial:
Name: Motor Neuroprosthesis to restore motor control from the COMMAND of digital devices: an early feasibility study of safety in subjects with severe quadriparesis
Study design: Prospective, multi-center, single-arm, open label
Sample size: 6 subjects
Duration: 15 months per subject: up to 90 days pre-implant, 12 months of follow-up
Endpoints: device-related serious adverse events within 12 months post-implant, target vessel patency and device migration on CT scan at 3 and 12 months
Secondary: digital device control, patient questionnaires
Eligible patients: severe paralysis in both arms and legs + good cognitive function + informed consent