Paradromics has begun actively recruiting patients for its Connect-One clinical study, the first human trial of the Connexus brain-computer interface designed to restore speech in people with severe motor impairment. Enrollment is now open at the University of Michigan and Massachusetts General Hospital, with UC Davis in Sacramento expected to follow.
The company confirmed the recruitment milestone on March 31 in a communication to its patient registry, four months after receiving investigational device exemption approval from the FDA on November 20, 2025. The early feasibility study will initially enrol two participants who have lost the ability to speak due to conditions such as ALS, stroke, or spinal cord injury, with a roadmap to expand to more participants and additional clinical sites.
The Connexus system consists of three implanted components: a cortical module smaller than a dime that sits on the surface of the brain’s motor cortex, a disk-shaped transceiver implanted in the chest, and a flexible extension lead connecting the two. The cortical module houses 421 platinum-iridium micro-electrodes, each thinner than a human hair, that record activity from individual neurons. Neural signals travel from the brain to the chest unit and then wirelessly through the skin via a secure optical link to an external transceiver worn by the patient. An AI-powered computer decodes those signals into synthesised speech, on-screen text, or mouse and keyboard commands.
Paradromics says the system can transmit data at more than 200 bits per second in pre-clinical models. The external transceiver also powers the implant inductively, eliminating the need for an implanted battery.
Three principal investigators are leading the study across the clinical sites. David Brandman, a neurosurgeon at UC Davis, heads the Sacramento site. Daniel Rubin, a critical care neurologist at Massachusetts General Hospital, leads the Boston arm. Matthew Willsey, a neurosurgeon with a biomedical engineering background at the University of Michigan, oversees the Ann Arbor site, which was added to the study in July 2025.
Eligible participants must be between 22 and 75 years old, have a progressive disease or injury that impairs speech, and live within four hours of one of the three sites. Candidates need prior experience with assistive communication devices. Those with existing implanted devices such as pacemakers or deep brain stimulators, or who require regular MRI scans, are excluded.
The study is designed to assess the technical performance of the Connexus system as well as its clinical benefits and quality-of-life impact over a six-year period. The first surgery is anticipated in the first half of 2026.
The Connect-One trial joins a growing roster of implantable BCI programmes in the clinic. Neuralink has enrolled more than 20 participants in its PRIME study, which focuses on cursor and device control. Synchron is trialling its next-generation Stentrode in Melbourne. Blackrock Neurotech continues its MoveAgain programme. But Paradromics is the only company with an active US trial specifically targeting speech restoration with a fully implantable device, an application that addresses a population ranging from people in the late stages of ALS to stroke survivors with severe aphasia.
The recruitment launch also follows the company’s announcement earlier this month of APEX, an academic partnership programme that gives university researchers access to the Connexus platform for neuroscience research beyond the clinical trial’s scope.