The U.S. neuroengineering corporations Paradromics (Paradromics) recently received the first long-term clinical trial authorization from the U.S. Food and Drug Administration (FDA) for its brain-computer interface (BCI) technology. The trial aims to restore communication abilities in people who lost speech due to neurological disease or accidents.
According to the journal Nature on the 21st, Paradromics plans to begin phase 1 of the trial early next year by implanting a BCI in two patients who lost speech due to neurological disease or accidents. The goals are to verify device safety and to restore real-time, speech-based communication.
A BCI is a technology that reads signals generated in the brain into a computer and converts them into text or speech. Paradromics' device is a circular chip about 7.5 mm in diameter with dense metal electrodes embedded, which pierce about 1.5 mm into the brain surface to read the activity of individual neurons. Information collected from the electrodes is delivered to a power and wireless communication unit implanted in the chest.
In the initial trial, electrodes are implanted in the motor cortex, the brain area responsible for vocal cord movement, and in the mouth and tongue. Participants imagine silently speaking sentences presented on a screen, and the BCI learns the brain-signal patterns at that time. Afterward, when the patient imagines speaking, the system outputs by converting those signals into on-screen text or by using the participant's past voice to deliver real-time synthesized speech.
This clinical trial is the first official clinical case of creating synthesized speech with BCI technology. Matt Angle, CEO (CEO) of Paradromics, said it is "an important first step in applying new hardware to actual patients," adding that "the area where current BCI can most improve patients' quality of life is 'communication.'"
Along with speech restoration, the trial will also test whether imagining hand movements can control a computer cursor. If the initial results are good, the number of participants will be increased to up to 10, and two more implants will be added to both brain hemispheres to secure more signals.
Paradromics said that in a three-year long-term experiment with sheep, the brain information transmission speed was about 20 times faster than other devices, and the device's signal quality barely declined. If this performance is reproduced in humans, a clinical BCI could operate stably for more than 10 years.
Competition in the BCI market is getting fiercer. The company considered most advanced is the U.S.-based Synchron. Synchron promotes a less invasive approach by inserting stent-shaped electrodes into blood vessels. It reads the activity of neuronal populations from inside blood vessels, and in an early trial, it tested whether participants could select on-screen options simply by imagining moving a foot.
Elon Musk's Neuralink is focusing on directly reading signals from as many individual neurons as possible to obtain high-resolution data. It inserts 64 electrode threads thinner than a human hair into the brain, enabling control of a computer or robotic device by imagining hand movements.
Leigh Hochberg (Leigh Hochberg), a Massachusetts General Hospital professor and a pioneer of BCI clinical research who led the first human trial in 2004, said, "It is important that various BCI technologies are developed so that patients are offered multiple options."
References
Nature (2025), DOI: https://doi.org/10.1038/d41586-025-03849-0