MOSCOW, June 16, Vladislav Strekopytov. The US regulator FDA allowed Elon Musk's company Neuralink to test neuroimplants in humans. Neurointerfaces, or, as they used to say, «brain-computer» systems, are engaged in hundreds of companies around the world, including in Russia. About the problems developers face in the material.
Neurotechnological revolution
Thanks to electroencephalography (EEG), invented in the early twentieth century, scientists found that neurons transmit information to each other by electrical impulses, established the purpose of different areas of the cerebral cortex.
In 1973, UCLA professor Jacques Vidal proposed the concept of a «brain-computer interface» (NCI) and formulated the task of creating technologies that make it possible to transform mental intentions into real actions.
In most neural interfaces, information passes through four stages: receiving a brain signal from surface electrodes (non-invasive option) or an implanted chip (invasive option); signal preprocessing and data transfer to a computer; interpretation and formation of digital commands; control of an executing device — a computer keyboard or mouse, a robotic prosthesis, a wheelchair, a car, and so on. » data-crop-ratio=»0.544055944055944″ data-crop-width=»600″ data-crop-height=»326″ data-source-sid=»rian_infographics» class=»lazyload» lazy=»1″ />< br />
The first NCIs were tested on animals in the late 1990s. According to the signals of the neurons of the cat's visual system, American neuroscientists have learned to recreate what the animals saw. In another experiment, deciphered brain activity data from monkeys was used to control a robotic arm. Later, with the addition of a feedback loop, it was used to restore the mobility of paralyzed limbs through electrical muscle stimulation.
New developments are constantly being reported these days. First of all, we are talking about helping people with disabilities.
For example, patients with spinal cord injury, paralysis of the limbs. Soon they will be able to control prostheses, control a wheelchair, work with information in computers and smartphones with the «power of thought». They are also testing brain chips for people with epilepsy, Parkinson's disease, blindness and other disorders.
But human trials are just beginning.
Neuralink and others
At the end of May, Elon Musk's Neuralink company received permission from the US Food and Drug Administration (FDA) for such tests of its NCI Link.
A chip the size of a small coin is implanted in the skull by a precision surgical robot. Thousands of tiny threads connect the chip to neural circuits in the brain. Bluetooth communicates with the computer.
Neuralink claims that Link is able to control prosthetic limbs, as well as revolutionize the treatment of Parkinson's disease, epilepsy and the consequences of spinal cord injury. In addition, the development will be useful in the treatment of obesity, autism, depression, schizophrenia and a number of other ailments.
This project is the loudest, but not the only one and far from the first. Synchron's Stentrode endovascular NCI has been testedin patients with severe paralysis. The experiment lasted 12 months. All this time, the neuroimplant, which was injected through the blood vessels into the brains of four volunteers, successfully transmitted neural signals to the computer. Paralyzed patients operated a wheelchair, used e-mail, created text messages, managed personal finances, made online purchases, and communicated with clinic staff. Francisco created a visual prosthesis Science Eye based on GCIfor patients with retinitis pigmentosa and age-related macular degeneration, two types of untreatable acquired blindness.
In such diseases, the light-sensitive cells in the back of the eye, the photoreceptors, die, but the optic nerve is preserved. Science Eye combines gene therapy with a neuroimplant, a thin-film ultra-dense microLED display panel inserted directly above the retina.
The data coming there is converted into a signal that is optogenetically transmitted to the optic nerve. Binocular cameras, sensors, a processor, an infrared connection unit with an implant, and batteries are built into the frame of special glasses. It is clear that the images generated by a visual prosthesis are very different from what people with normal vision see. But a person can estimate the size of objects in front of him, the distance to them, distinguish moving objects from stationary ones.
For more than five years, the BrainGate HCI, created by neurologists and neurosurgeons at Massachusetts General Hospital in collaboration with colleagues from seven US medical centers, has been tested. The interface was tested on 14 patients with paralysis after spinal cord injury, brainstem stroke, motor neurone disease, or muscular dystrophy. The main element of BrainGate is a subcutaneous chip with an array of microelectrodes implanted in the primary motor cortex, which transmits signals from the brain to various assistive devices and a computer.
Researchers from the startup Onward, led by Grégoire Courtin of the Swiss Federal Institute of Technology Lausanne, specifically for 38-year-old patient, paralyzed after a car accident, developedcomplex NCI. The first element, located on the head, decodes the signals of the brain that initiate movements, and transmits them to the second — in the section of the spinal cord responsible for the motor skills of the legs. This «digital bridge» allows you to bypass the damaged cervical area. Thanks to artificial intelligence algorithms integrated into the NCI, the system learned to understand neural signals associated with various muscle contractions, and the patient was able to stand up, walk, climb stairs and even overcome uneven terrain.
There are other examples of successful human trials of neuroimplants in the US and other countries .
“Neuroimplantation has a rather long history,” says a neurophysiologist, associate professor at the Engineering and Physical Institute of Biomedicine at the National Research Nuclear University MEPhI, Doctor of Medical Sciences Sergey Gulyaev. new treatments for Parkinson's disease, alcohol and drug addictions, and epilepsy.»
However, the difficulties of introducing foreign objects into the human body, possible infection and rejection of implants hindered the widespread use of NCI in medicine. «All this is being solved by bioprinting technologies, the development of tissue-compatible polymers and nanotechnologies. So now there is a real renaissance here,» the scientist notes. Technology Initiative (NTI) develops the «NeuroNet» direction with the task of creating «man-machine communication tools based on advanced developments in neurotechnologies and increasing the productivity of human-machine systems, the productivity of mental and thought processes.» Founded branch union of the same nameis a non-profit partnership uniting thousands of specialists and experts, hundreds of small businesses. Launched dozens of projects.
«In 2015, we formulated a roadmap, our vision of what technologies on the horizon of ten to twenty years will come out of laboratories and turn into real products, services,» says the leader of the working group for the development and implementation of the Neuronet roadmap, head of the department of Innovative Pharmaceutics and Biotechnology of the Moscow Institute of Physics and Technology, Andrey Ivashchenko, head of the pharmaceutical company ChemRar — One of the six segments of this plan is dedicated to neuromedical technology, where everything related to neurotechnologies in medicine is collected in one way or another: equipment, exoskeletons, prostheses, neurointerfaces — invasive and non-invasive methods
Sensor-Tech has already prepared an implant to restore vision Elvis. A microchip on the skull stimulates the visual cortex of the brain with weak currents. An external headset consisting of a hoop with a camera mounted on the head and a microcomputer unit processes the image using intelligent algorithms. The project has private investors. Human trials will start next year.
The Motorika company, together with the Medical Center of the Far Eastern Federal University and the Skoltech Center for Neurobiology and Neurorehabilitation named after V. Zelman, is testing the NEMO Sensitive neuromodulation platform designed to relieve phantom pain and feel prosthetic limbs. The development belongs to the group of invasive NCI. In November 2021, in Vladivostok, two men who lost their hands were implanted with electrodes connecting the remaining nerve endings to mechanical fingers. After the operation, patients were able to feel the force of compression of the prosthesis, to feel the object and even its temperature.
As part of the consortium of the Bionic Engineering in Medicine Center of the NTI, Motoriki specialists and scientists from the Samara State Medical University are creating neural interfaces for controlling prostheses of the upper and lower extremities. Animal studies are ongoing.
Clinical trials, licensing and approval from Roszdravnadzor are required for these and other Russian invasive NCI projects. But the main thing is the source of funding.
“Clinical trials are several orders of magnitude more expensive than preclinical studies,” Ivashchenko notes. “Without state support, everything will remain at the level of experimental developments. Our geopolitical competitors have switched to clinical trials. level».
“So far, not a single project in the world has become commercial,” continues Vladimir Konyshev, head of the MIPT Neurobotics Laboratory, CEO of the Neurobotics group of companies, who is responsible for the neuromedtech segment at Neuronet. “Both Neuralink and Sensor-Tech are moving on to testing We are not far behind in terms of pilot studies. We are technically behind, there is no regulatory framework. And the funding of our companies is not at all like that of Elon Musk. So far everything rests on individual enthusiastic developers supported by enthusiastic investors, and this needs to be changed, otherwise our guys who suffered in the NMD will have to buy equipment from the Americans.»
Today, all chips for neurodevices are produced in the USA. The vast majority of developments and scientific publications on this topic are also American.
«The reason is the weakness of our education in the field of neuroscience,» explains Konyshev. «We traditionally have a strong fundamental science, and the whole world is actively moving towards modern technologies. Until we have professionals in this field, we will lag behind. Now it is very difficult to find employees for neurotechnological projects. Fortunately, the situation is gradually changing. This year, a master's program in neuroprosthetics is being opened at Pirogov Russian National Research Medical University.»
Recently, the government approved the Technological Development Vision 2030, which lists the main directions needed to «achieve technological sovereignty and transition to innovation-driven economic growth.» For the first time, neurotechnologies are listed among the priorities.