Paradromics receives FDA approval to trial brain transplantation in humans
Brain implant developer Paradromics has received FDA approval to test its device in early-stage human trials, the company announced Thursday.
The Austin-based company aims to give a digital voice to people who have lost the ability to speak due to a severe motor disability. The trial will evaluate the long-term safety of the Paradromics device, as well as its ability to enable complex speech and text communication.
Paradromics is one of several companies — which include Neuralink, Synchron, Precision Neuroscience, and Cognixion — working on technology to control computers and other devices that use brain waves. Known as brain-computer interfaces, or BCIs, these systems capture brain signals associated with movement intent and translate them into commands.
The Paradromics study is scheduled to begin early next year and includes two individuals. After collecting data on the first participants for six months, the company plans to ask the Food and Drug Administration to expand the study to include more volunteers.
“It’s reasonable to think that someone will communicate at 60 words per minute and be able to really carry on a conversation,” says Matt Angel, CEO and founder of Paradromics, referring to the rate achieved by previous BCI trials led by academic groups. Normal speaking speed is between 120 and 150 words per minute.
Speech Restoration BCIs do not read a person’s inner thoughts. Rather, it decodes certain signals from the brain’s motor cortex that are generated when a person tries to move their muscles to speak. Users are asked to try saying sentences out loud so that the brain-to-brain interface (BCI) learns to recognize brain patterns associated with speaking.
“They’ll just try to say the words, and those words will appear very quickly on the screen. They’ll press play, and the words will be read out in their voice,” Angel says. Assuming there is an existing recording of the participant’s voice, Angel says the company plans to create an audio transcript of that person using artificial intelligence.
Earlier this year, Paradromics briefly implanted its device in a person who was already undergoing brain surgery. Surgeons used an EpiPen-like tool to insert and remove the implant. In this procedure, the device remained in the brain for only 10 minutes and was not used to restore speech. In the trial scheduled to take place next year, the device will be implanted in the long term.
The Paradromics implant, called the Connexus, is a metal disc smaller than the size of a dime with 421 fine-wire electrodes that sit in brain tissue and record from individual neurons. In comparison, the Neuralink implant is a quarter-sized chip placed in the skull that contains more than 1,000 electrodes across 64 tiny wires that are “wired” into the brain by a specially designed robot. Neuralink has Transplant at least 12 people Around the world with his device.