Paradromics receives FDA approval to test its brain implant in humans
Brain implant developer Paradromics has received approval from the US Food and Drug Administration to test its device in early-stage human trials, the company announced Thursday.
The Austin-based company aims to give digital voice to people who have lost the ability to speak due to severe movement disorders. The trial will evaluate the long-term safety of the Paradromics device as well as its ability to enable combined speech and text communication.
Paradromics is one of several companies, including Neuralink, Synchron, Precision Neuroscience and Cognixion, working on technology to control computers and other devices using brain waves. These systems, known as brain-computer interfaces, or BCIs, record brain signals related to movement intent and translate them into commands.
The Paradromics study is scheduled to begin early next year and will include two subjects. After collecting data from the first two participants for six months, the company plans to ask the FDA to expand the study to include more volunteers.
“It’s reasonable to think that someone is communicating at 60 words per minute and can actually maintain a conversation,” says Matt Angle, CEO and founder of Paradromics, referring to the rate achieved by previous BCI experiments by academic groups. Normal speaking speed is between 120 and 150 words per minute.
BCIs do not read a person’s inner thoughts to restore speech. Instead, they decode specific signals from the motor cortex of the brain that are produced when a person tries to move their muscles to speak. Users are asked to say sentences out loud so that the BCI learns how to recognize the brain patterns associated with speaking.
“They just try to say the words, and those words appear on the screen very quickly. They press play and the words are read out loud,” says Angle. Angle says that assuming the participant’s voice is recorded, the company plans to use artificial intelligence to produce a voice clone of that person.
Earlier this year, Paradromics briefly implanted its device in a person who had previously undergone brain surgery. Surgeons used an EpiPen-like tool to insert and remove the implant. In that procedure, the device remained in the brain for only 10 minutes and was not used to restore speech. In a trial planned for next year, the device will be implanted for an extended period of time.
Paradromics’ implant, called Connexus, is a metal disk smaller than the size of a dime with 421 microwire electrodes embedded in brain tissue and recording from individual nerve cells. In comparison, the Neuralink implant is a chip the size of a quarter that is inserted into the skull and has more than 1,000 electrodes on 64 tiny wires that are “fed” into the brain by a custom-built robot. Neuralink has implanted at least 12 people worldwide with its device.
