Connect-One Early Feasibility Study of the Connexus Brain-Computer Interface to Help People with Severe Motor Control Loss Communicate and Control Devices

What this Trial Is About

Researchers are evaluating the Connexus Brain-Computer Interface BCI in an early feasibility study to gather initial safety data. The Connexus BCI is designed to help people with severe loss of voluntary motor control, enabling communication by decoding imagined language and speech. It also aims to assist with controlling computer devices for individuals with impaired upper limb function due to conditions like amyotrophic lateral sclerosis, stroke, or spinal cord injury. The study involves implanting the Connexus Brain-Computer Interface device, which is an implantable technology. Participants will use the device to explore its potential as an assistive communication tool and control aid. The study will monitor safety outcomes related to the device over periods extending up to 12 months initially and up to 6 years for long-term safety. Participants will be closely followed with assessments focusing on device-related adverse events. The research team will evaluate both primary safety within the first year after implantation and long-term safety over several years. Participants will need a care partner and live within a reasonable distance from the study site to support their involvement throughout the study duration.

Connect-One: Early Feasibility Study of Connexus® Brain-Computer Interface (BCI)