A brain-computer interface device has received FDA approval to begin human trials for speech restoration in paralysed patients.
The Connexus BCI system will be tested in participants with severe motor impairment who have lost the ability to speak and move their limbs.
The device is designed to record and decode brain signals, allowing users to control computers and communicate through text or synthesised speech.
Brain-computer interface technology enables direct communication between the brain and external devices by interpreting neural signals.
US neurotechnology company Paradromics received Investigational Device Exemption (IDE) approval from the Food and Drug Administration, making it the first company to gain IDE approval for speech restoration using a fully implantable BCI.
The Connect-One study will initially enrol two participants who have impaired speech and limited movement in both upper and lower limbs due to severe loss of voluntary motor control.
Participants must live within four hours of the three clinical sites: UC Davis in Sacramento, Massachusetts General Hospital in Boston, and Harvard Medical School.
The study will be led by investigator Matthew Willsey, a neurosurgeon with dual faculty appointments in neurosurgery and biomedical engineering at the University of Michigan.
“In Q1 next year we are launching a clinical study with the best engineered brain computer interface in the world,” said Paradromics chief executive and founder Matt Angle.
“This is the device that patients deserve.”
The company claims its Connexus BCI delivers what it describes as an industry-leading rate of information transfer of more than 200 bits per second, based on preclinical models.
The FDA approval follows three years of stable preclinical recordings and the first successful acute Connexus BCI implantation at the University of Michigan by Dr Willsey.
Paradromics plans to expand the Connect-One study to include additional sites and more participants, while exploring new BCI applications.
The initial focus will be on restoring speech capabilities.
The company says it plans to develop AI-powered treatments for motor impairment initially, with future applications potentially addressing chronic pain, addiction, depression and other neurological conditions.
The technology builds on recent advances in the brain-computer interface field.
Earlier this year, a patient demonstrated the ability to fly a remote-controlled aeroplane using only his thoughts through a different BCI system.
Alex Conley, operating from his electric wheelchair, not only flew the aircraft but also wrote the Arduino code to control it using brain signals.
Neuralink, the brain implant company founded by Elon Musk, is also conducting human trials of its device designed to help paralysed people operate computers with their thoughts.
The Connect-One study represents the first in a series of planned clinical applications for the Paradromics BCI platform, with recruitment expected to begin in the first quarter of next year.
