Summary: Neurosurgeons have completed the first-in-human clinical implant of the Paradromics Connexus wireless brain-computer interface (BCI). The procedure aims to restore natural communication to a female participant suffering from a severe motor neuron disease.
Utilizing a cortical array of 421 microelectrodes connected to an implantable chest transceiver, the system decodes neuronal activity to broadcast thought-driven text and synthesized speech wirelessly, representing a monumental shift toward practical, infection-resistant neuroprosthetics for patients living with paralysis.
Key Facts
- First-In-Human Milestone: Neurosurgeons at Michigan Medicine successfully completed the inaugural permanent implant of the Paradromics Connexus wireless BCI.
- 421-Microelectrode High Density: The implant uses a specialized intracortical array featuring 421 microelectrodes to intercept and record electrical signaling from individual neurons.
- Fully Wireless Architecture: Unlike older, wired laboratory systems, the decoded cortical signals are funneled to a chest transceiver and broadcasted completely wirelessly to external digital interfaces.
- Six-Year Clinical Safety Window: The study participant will be comprehensively tracked for six years to gauge the device’s durability, bio-compatibility, and therapeutic consistency.
- Targeting Motor Neuron Diseases: The trial specifically focuses on reversing the communicative isolation caused by degenerative motor neuron disorders like amyotrophic lateral sclerosis (ALS) and primary lateral sclerosis (PLS).
Source: University of Michigan
Neurosurgeons at University of Michigan Health completed the first-in-human implant of a Paradromics Inc., wireless brain-computer interface, or BCI, as part of a national clinical trial for patients with difficulty speaking.
Matthew Willsey, M.D., Ph.D., a neurosurgeon and biomedical engineer, and Aditya S. Pandey, M.D., Chair of the U-M Health Department of Neurosurgery, implanted the Connexus BCI into a woman from Michigan.
The participant struggles to speak due to motor neuron disease.
The clinical trial, called the Connect-One Early Feasibility Study (EFS), will focus on the device’s long-term safety. It will also assess whether the BCI can restore the participant’s communication through synthesized text and speech, and help them control a computer.
“We are incredibly excited to investigate the potential of this wireless BCI to restore communication for people who have lost the ability to speak due to neurological disease or injury,” said Willsey, a Site Principal Investigator for the study who led the implant surgery.
“This has the potential to be a major step forward as we work toward our goal of helping treat people with paralysis who otherwise lack efficient and effective therapies for preserving communication.”
The Connexus BCI is one of only a few wireless, fully implantable BCIs being tested in the United States.
Like other BCIs, it is designed to decode brain signals and translate them into action by allowing the user to control a device with their thoughts.
The Paradromics device contains 421 microelectrodes that capture brain signals from individual neurons. Those signals travel to a small transceiver in the user’s chest that sends information to an external receiver.
“Enrolling our first participant at University of Michigan is a defining moment for our company and for the field,” said Matt Angle, Ph.D., CEO and founder of Paradromics.
“Our goal is to restore natural communication for people who have lost the ability to speak and help them stay connected with their loved ones. We’re proud to partner with University of Michigan Health on this first-in-human study as we build the foundation for the next generation of clinical BCIs.”
In June of 2025, Willsey and Oren Sagher, M.D., Director of Functional Neurosurgery at U-M Health, temporarily implanted the Connexus in a patient as part of epilepsy research which also confirmed that the device could be safely placed into the brain and record signals.
The U.S. Food and Drug Administration granted Paradromics an Investigational Device Exemption (IDE) to begin the Connect-One clinical study in November 2025. Michigan Medicine is one of three sites enrolling participants for the study.
“The Paradromics device has incorporated decades of learning from intracortical BCI research, and this study represents the next big step to investigate whether a fully implanted and wireless BCI can restore communication,” said David M. Brandman, M.D., Ph.D., Lead Principal Investigator of the Connect-One Study and Associate Professor of Neurosurgery at University of California, Davis.
“I’m honored to be leading this study together with Drs. Willsey and Rubin.”
The participant will be followed for six years following the BCI implant. In addition to meeting with the study team regularly, she will continue to receive motor neuron disease care from the Stanford Morris ALS Clinic at U-M Health.
Motor neuron disorders are a group of diseases that impact the function of the brain, brainstem and spinal cord motor neurons. This includes amyotrophic lateral sclerosis (ALS), which is the most common motor neuron disorder, and primary lateral sclerosis (PLS).
Given the impact on effective communication for those living with such conditions, wireless BCI devices represent an important area of research.
“It is critical to preserve communication for all those living with motor neuron disease to keep individuals connected to their families and friends, and to preserve independence and quality of life,” said Stephen Goutman, M.D., M.S., Director of the Stanford Morris ALS Clinic, Associate Director of the Scott Pranger ALS Center and Harriet Hiller Research Professor at U-M.
“We are so fortunate to be able to partner with Dr. Willsey and the incredible neurosurgical team here at U-M Health as they work to bring these devices into the clinic and make motor neuron diseases more livable.”
Willsey is leading a new Brain-Computer Interface Clinic that opened at U-M Health in 2025.
His lab, which is focused on developing the next generation of brain-computer interfaces, is the sponsor-investigator of a separate clinical trial testing a novel investigational BCI to restore movement and communication.
“Advances in brain-computer interfaces and neuromodulation are rapidly reshaping what is possible in the treatment of neurological disease,” Sagher said.
“Our clinician-scientists are committed to developing and advancing these technologies and ensuring that patients have access to the most innovative and effective therapies available. When patients come to Michigan Medicine for their care, they should know they are being treated at a center helping define the future of neuroscience and neurosurgical care.”
Key Questions Answered:
A: When a person imagines speaking, their brain’s motor cortex still fires electrical signals along the neural pathways originally dedicated to moving the tongue, lips, and vocal cords, even if those muscles no longer function. The 421 microelectrodes on the Connexus device capture these precise patterns of electrical firing. Advanced machine-learning algorithms then decode these complex neural rhythms in real time, mapping specific patterns to distinct words or characters, which are immediately outputted as digital text or synthesized audio.
A: Early intracortical brain-computer interfaces required a physical wire to pass through a permanent opening in the patient’s skull, connecting directly to a massive laboratory computer rig. This setup carried a continuous risk of infection and confined the patient’s device use to a clinical lab setting. A fully implantable, wireless system completely seals the hardware beneath the skin, lowering infection markers and allowing the participant to eventually use their digital communication tool seamlessly at home.
A: The Connect-One study is an Early Feasibility Study (EFS) operating under an FDA Investigational Device Exemption across three national clinical sites. It is specifically enrolling individuals who experience profound communication deficits due to motor neuron diseases, such as amyotrophic lateral sclerosis (ALS) and primary lateral sclerosis (PLS). Because it is an early-stage human trial, the primary, absolute goal is proving the long-term safety, bio-stability, and recording integrity of the hardware inside the body over a multi-year timeline.
Editorial Notes:
- This article was edited by a Neuroscience News editor.
- Journal paper reviewed in full.
- Additional context added by our staff.
About this ALS and neurotech research news
Author: Noah Fromson
Source: University of Michigan
Contact: Noah Fromson – University of Michigan
Image: The image is credited to Neuroscience News
