Paradromics Connexus BCI Enables First Participant to Communicate in Real Time Using Neural Signals
Paradromics Inc., a neurotechnology company developing a high-data-rate brain-computer interface (BCI) platform aimed at restoring and enhancing human capabilities, has announced a major clinical milestone involving its Connexus® BCI system. The first participant implanted with the fully implantable device has successfully used the system for real-time speech and text communication, demonstrating the potential of direct neural interfaces to restore communication for people whose ability to speak has been severely affected by neurological disease.
The achievement was reached as part of the Connect-One Early Feasibility Study, which is being conducted under an Investigational Device Exemption (IDE) approved by the U.S. Food and Drug Administration (FDA). The latest demonstration represents an important progression beyond controlled, researcher-directed communication tasks. During the session, the participant independently selected the words she wanted to communicate, responded to open-ended questions, and used the Connexus system to communicate with her grandchildren during a live telephone call.
The demonstration established a real-time communication loop in which neural activity associated with speech and language was recorded, decoded into language, and then converted into text and synthesized speech. The result allowed the participant to express her own thoughts without relying on a predetermined set of words or phrases selected by researchers.
Moving From Structured Tasks to Free Communication
For BCI technology, one of the major challenges is moving from laboratory demonstrations involving predefined words or commands to communication that reflects the spontaneous choices and intentions of the person using the system.
Paradromics’ latest results mark progress toward that goal. Rather than simply selecting from a limited vocabulary or responding to predetermined prompts, the first participant was able to decide what she wanted to say and have that intended communication decoded in real time.
“When we implanted Connexus in June, we crossed the threshold into long-term human use. We have now crossed another: our first participant is choosing her own words and using neural activity to communicate them in real time,” said Matt Angle, PhD, founder and CEO of Paradromics.
“She determines what she wants to say, and the system enables her to say it,” Angle added.
The significance of the milestone is particularly relevant for people who retain cognitive and language abilities but have lost the physical capacity to communicate effectively because of neurological disease.
Participant Uses Connexus to Express Her Own Words
The first participant is a woman in her 60s from Michigan who is living with a progressive motor neuron disease that has substantially affected her ability to speak.
Motor neuron diseases are a group of neurological disorders that affect voluntary movement and can impair functions such as speech and mobility. Conditions within this group include amyotrophic lateral sclerosis (ALS) and primary lateral sclerosis (PLS).
The participant has severe dysarthria and retains only limited speech. Although her husband is often able to understand what she says, communicating with other people has become increasingly difficult as her condition has progressed.
When the Connexus system was activated for free-speech communication, she selected a sentence that reflected both her experience and the significance of participating in the research.
“Okay, I have a lot to say,” she communicated.
The sentence was generated by the participant and decoded by the system in real time exactly as she intended, without errors.
The demonstration illustrates the potential importance of communication technologies for individuals whose ability to physically produce speech is impaired while their desire and ability to formulate language remain intact.
Communicating With Family Through a Live Phone Call
The participant subsequently demonstrated another important capability by using Connexus to communicate with family members during a live telephone conversation.
During the session, she asked her grandchildren questions and responded to them using speech generated by the BCI system. The demonstration extended the technology beyond an experimental laboratory interaction and into a familiar social setting involving direct communication with family.
Matthew Willsey, MD, a University of Michigan Health neurosurgeon and investigator in the Connect-One study, highlighted the significance of the achievement.
“The participant and the Paradromics team have achieved a major milestone by demonstrating the ability to speak freely through a fully implantable device designed for clinical use,” said Dr. Willsey.
“Restoring communication may soon be available to others with diseases impacting the ability to speak,” he added.
The ability to participate in conversations with family members is an important objective for communication-focused BCIs because speech is not simply a mechanism for conveying information. It also enables individuals to maintain personal relationships, express preferences, ask questions, share experiences, and participate more fully in everyday life.
Recording Neural Activity at Individual-Neuron Resolution
The Connexus BCI is designed to record neural activity at the resolution of individual neurons and wirelessly transmit that information through intact skin to an external computing system.
Paradromics is using the early feasibility study not only to demonstrate communication but also to investigate the underlying neural signals associated with different stages of language processing.
Researchers are examining how neural activity changes as the participant listens to language, prepares to speak, attempts to speak, and generates language internally. Data collected so far indicate that speech-related information can be detected across hundreds of neural recording channels.
These signals appear as distinct patterns that vary according to the task the participant is performing.
The ability to capture neural activity at this level of resolution could provide researchers with additional information about how language is represented in the brain and how those neural patterns change during different communication states.
Insights Into Attempted and Imagined Speech
An important observation from the first participant involves the distinction between attempted speech and imagined speech.
Attempted speech occurs when an individual tries to physically produce spoken language, even when neurological impairment prevents normal vocalization. Imagined speech, sometimes referred to as inner speech or the inner voice, occurs when a person internally generates language without physically attempting to speak.
Paradromics has identified distinct patterns of neural activity associated with both states.
These observations could be important for the development of future communication systems because individuals with severe motor impairment may have different levels of residual speech ability. Some people may still be able to attempt speech movements, while others may depend more heavily on internally generated language.
Vikash Gilja, PhD, Chief Scientific Officer of Paradromics, said the company is examining these different neural states across populations of individual neurons.
“Across populations of individual neurons, we can see structure associated with listening, preparing to speak, attempted speech and imagined speech,” said Gilja.
He explained that longitudinal data from the study provide an opportunity to determine where those different neural states overlap and where they diverge.
Researchers are also examining how stable the information remains over time and how both the participant and the decoding system adapt to one another.
“Those insights will help us build communication that becomes more accurate and more natural for the person using it,” Gilja said.
FDA-Authorized Early Feasibility Study
The Connexus demonstration is part of Paradromics’ Connect-One Early Feasibility Study, which received FDA approval of an Investigational Device Exemption in November 2025.
The study is designed to evaluate the Connexus system in humans and generate clinical and technical information that can guide further development of the technology.
David M. Brandman, MD, PhD, serves as Lead Principal Investigator at UC Davis Health. Daniel Rubin, MD, PhD, at Mass General Brigham Neuroscience Institute, and clinical teams at University of Michigan Health are also participating across the three study sites.
Dr. Brandman described the first participant’s ability to communicate using Connexus as a major milestone for the BCI field.
“The very first participant implanted with the Connexus system has been empowered to say whatever she wants to say using her brain-computer interface,” said Dr. Brandman.
“This is a landmark milestone for the field. I’m excited for what the future has in store for her and look forward to learning more about how the Connexus system can be used to help others,” he added.
Studying the Brain’s Internal Language Signals
Beyond restoring outward communication, the data collected through the Connect-One study are giving Paradromics an opportunity to examine the neural processes that occur before a person actually speaks.
In everyday communication, people frequently formulate and refine what they want to say before producing words aloud. This internal process can include rehearsing a phrase, deciding how to express an idea, or modifying language before communicating it.
This internal form of language is commonly described as imagined speech, inner speech, or the inner voice.
Paradromics believes understanding the neural signals associated with these processes could help guide future BCI development and potentially identify which types of neural interfaces may be most appropriate for different patient populations.
Angle said the early feasibility study is intended in part to deepen the company’s understanding of how different areas of the brain process different forms of language.
“Part of the early feasibility study that we are undertaking is to better understand which brain areas handle different types of language information, and how best to use that information for restoring communication,” Angle said.
“This will help us understand what types of future patients would benefit from implants in what areas,” he continued.
Connecting Human Intent With Artificial Intelligence
Paradromics also sees the broader potential of high-resolution neural interfaces extending beyond speech restoration.
As BCI systems become capable of capturing increasingly detailed information about neural activity, they could potentially provide new interfaces between human intention and digital systems.
Angle described the technology being developed through the Connect-One program as a sophisticated connection between human intention and artificial intelligence.
“In the process of doing this,” Angle said, “we are also building what is effectively the world’s most sophisticated conduit between human intention and AI.”
Looking ahead, he said BCI users could potentially use these interfaces to interact more effectively with AI systems.
“In the not-too-distant future, BCI users will be able to more effectively query and control AI models like the ones that many of us use every day,” Angle added.
For now, however, the immediate focus remains on demonstrating safe and effective communication for people who have lost the ability to speak because of neurological disease.
The first participant’s successful use of Connexus represents an important step in that effort. Her ability to select her own words, answer open-ended questions, communicate with family, and generate both text and synthesized speech demonstrates the potential of a fully implantable BCI to move beyond controlled research tasks toward more natural communication.
As the Connect-One study continues, longitudinal data from the implanted system are expected to help Paradromics better understand speech-related neural signals, evaluate how those signals evolve over time, and refine the decoding technology. The company’s work could ultimately contribute to a new generation of neurotechnology designed to restore communication and provide people with severe speech impairments a more direct way to express their thoughts and intentions.
About Paradromics
Paradromics builds brain-computer interface (BCI) technologies for seamless human-technology integration, designed to restore and enhance human capabilities. The company’s first-generation device, the Connexus® BCI, is designed to capture neural activity at the resolution of individual neurons and translate neural intent into speech, computer control, movement, and other essential human functions.
Paradromics’ first clinical application focuses on restoring communication for people who have lost the ability to speak due to paralysis and other severe motor impairments. Over time, the platform is designed to support direct AI interaction, advanced prosthetics, sensory feedback, and next-generation treatments for mental health and other neurological conditions. With each new application, Paradromics aims to create a new path to functional recovery and the extension of human agency and intention. For more information, visit www.paradromics.com.
Caution: Connexus® BCI is an investigational device limited by United States law to investigational use. Connexus® and Paradromics™ are trademarks or registered trademarks of Paradromics Inc. All other trademarks are the property of their respective owners.