Paradromics, a brain-computer interface startup based in Austin, Texas, has received approval from the Food and Drug Administration (FDA) to conduct a human trial aimed at restoring speech in individuals with paralysis. This significant development marks Paradromics as the first company to gain Investigational Device Exemption (IDE) status for a fully implantable brain-computer interface (BCI) focused on speech restoration.
The trial, named the Connect-One Early Feasibility Study (EFS), will initially involve two participants. These volunteers will have the Connexus BCI surgically implanted to record signals from individual neurons in the motor cortex, the area of the brain responsible for speech. According to the company, the aim is to enable patients to communicate through text or synthesized voice, enhancing their ability to interact with the world.
The Connexus device is designed for long-term medical use, featuring a titanium-alloy body and over 400 platinum-iridium electrodes. Each electrode, measuring less than 40 microns—thinner than a human hair—will be placed in close proximity to neurons to capture brain signals effectively. The system includes a cortical module, an internal transceiver, and an extension lead, all implanted under the skin. These components work together to transmit data wirelessly to an external device.
In a statement, Matt Angle, the chief executive of Paradromics, expressed enthusiasm for this new phase of research, saying, “We’re very excited about bringing this new hardware into a trial.” The small size of the initial trial allows researchers to focus on refining the technology’s performance and safety.
Innovative Approach to Speech Restoration
Participants in the trial will have one electrode array implanted in the motor cortex region that controls speech-related muscles. They will be asked to imagine speaking sentences displayed to them, while the system records the corresponding neural activity. This process aims to personalize the technology, allowing it to learn the specific patterns of brain activity associated with each intended speech sound.
The trial is particularly notable as it is the first BCI study targeting real-time synthetic voice generation. Information collected from the brain signals will be converted to audio based on previously recorded speech samples of the participants, facilitating more natural communication. Additionally, the study will explore the potential for the BCI to detect imagined hand movements, which could enable users to control a computer cursor.
If the initial phase of the trial yields positive results, Paradromics plans to expand the study to include a group of ten participants. This larger cohort may involve two implants for some participants, enhancing the system’s ability to capture signals.
Expert Perspectives on the Trial
The significance of this trial extends beyond Paradromics. According to Mariska Vansteensel, a BCI researcher at the University Medical Center Utrecht in the Netherlands, “For the field to move forward towards clinical applications, a fully implantable system is the only way to go.” This sentiment underscores the importance of developing reliable and effective technologies to improve the quality of life for individuals with severe communication impairments.
As the trial progresses, it will be monitored closely by both the medical community and potential users of the technology. The outcomes could pave the way for breakthroughs in assistive communication devices, highlighting the growing impact of brain-computer interface technologies in healthcare.