Creator of brain implants The company announced Thursday that Paradromics has received approval from the U.S. Food and Drug Administration to test its device in early-stage human trials.
The Austin-based company’s goal is to provide a digital voice to people who have lost the ability to speak due to severe motor disorders. The study will evaluate the long-term safety of the Paradromics device, as well as its ability to enable speech synthesis 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 using brain waves. These systems, called brain-computer interfaces (BCI), capture brain signals related to movement intention and translate them into commands.
The Paradromics trial is scheduled to begin early next year and involve two people. After collecting data on the first two participants for six months, the company plans to ask the FDA to expand the study to more volunteers.
“It’s reasonable to assume that someone will communicate at 60 words per minute and be able to really sustain a conversation,” says Matt Angle, CEO and founder of Paradromics, referring to the pace achieved in previous BCI studies conducted by academic groups. Normal speaking speed is 120 to 150 words per minute.
Speech restoration BCIs do not read a person’s internal thoughts. Instead, they decode certain signals from the brain’s motor cortex that are generated when a person tries to move muscles to speak. Users are asked to try saying the sentences out noisy so that BCI learns to recognize brain patterns associated with speaking.
“They will just try to say the words and those words will appear on the screen very quickly. They will press play and the words will be read in their own voice,” Angle says. Assuming there is a recording of a participant’s voice, Angle says the company plans to generate a clone of that person’s voice 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 instrument to insert and remove the implant. During this procedure, the device remained in the brain for only 10 minutes and was not used to restore speech. In a study scheduled for next year, the device will be implanted long-term.
Paradromics’ implant, called Connexus, is a metal disk smaller than a coin that contains 421 microwire electrodes placed in brain tissue and recording data from individual neurons. By comparison, the Neuralink implant is a quarter-sized chip placed in the skull and containing more than 1,000 electrodes arranged in 64 miniature wires that are “screwed” into the brain by a specially designed robot. Neuralink has implanted in at least 12 people around the world with your device.