OhRan Knowlson, a British teenager with a severe form of epilepsy called Lennox-Gastaut syndrome, became the first person in the world to try out a new brain implant last October, with phenomenal results: his daytime seizures were reduced by 80%.
“It has had a huge impact on his life and prevented him from having falls and injuries like he was suffering before,” says Martin Tisdall, a consultant paediatric neurosurgeon at Great Ormond Street Hospital (Gosh) in London, who implanted the device. “His mother talked about how it has greatly improved his quality of life, but also his cognition – he is more alert and more focused.”
Oran’s neurostimulator sits beneath your skull and sends constant electrical signals deep into your brain to block abnormal impulses that trigger seizures. The implant, called Picostim and about the size of a cellphone battery, is recharged via headphones and works differently between day and night.
“The device has the ability to record brain activity and measure it, which allows us to think about ways we could use that information to improve the effectiveness of the stimulation that children receive,” says Tisdall. “What we really want to do is offer this treatment on the NHS.”
As part of a pilot project, three more children with Lennox-Gastaut syndrome will be implanted in the coming weeks, and a full trial involving 22 children will be carried out early next year. If all goes well, the academic sponsors (Gosh and University College London) will apply for regulatory approval.
Tim Denison, professor of engineering sciences at the University of Oxford and co-founder and chief engineer of London-based Amber Therapeutics, which developed the implant with the university, hopes the device will be available on the NHS within four to five years and worldwide.
The technology is part of a growing number of neural implants being developed to treat a wide range of diseases, including brain cancer, chronic pain, rheumatoid arthritis, Parkinson’s, incontinence and tinnitus. These devices are more sophisticated than previous implants, as they not only decode the brain’s electrical activity, but regulate it. It is also an area in which Europe is competing with the United States in a race to develop this life-changing technology.
Amber is not the only company working on brain implants to treat epilepsy. NeuroPace in California has developed a device that responds to abnormal brain activity and has been approved by the U.S. regulator for use by children over 18. However, the battery is not rechargeable and must be replaced surgically after a few years. Other devices are placed on the chest, with wires running to the brain, and must be readjusted as a child grows.
When people talk about brain chips, most people think of Elon Musk’s startup Neuralink, also based in California. The company just implanted a brain chip in a second person with a spinal cord injury. The device uses tiny wires thinner than a human hair to pick up signals from the brain and translate them into actions.
The implant has been modified after several wires became dislodged in the first person to receive it in January, Noland Arbaugh, who is paralyzed from the neck down. It has allowed him to control a mouse cursor on a computer screen with his thoughts, which he says makes him feel as if he is Star Wars Jedi “using the Force.”
Other US companies, such as Synchron, backed by Bill Gates and Jeff Bezos, have also recently implanted brain-computer interfaces (BCIs) in people who cannot move or speak.
But scientists say such implants simply decode electrical signals. Instead, several American, British and European companies, such as Amber, are working on modulating the signals in what is called “BCI” therapy (deep brain stimulation) to treat diseases. Amber’s implant is also being used in academic trials for Parkinson’s disease, chronic pain and multiple system atrophy, which causes gradual damage to nerve cells in the brain. The company has also sponsored an early trial in Belgium to treat incontinence, with promising results.
Another type of technology will be tested on humans in a clinical trial starting in a few weeks, using the first brain implant made from graphene, the “wonder material” discovered at the University of Manchester two decades ago.
A team at Salford Royal Hospital will place a device with 64 graphene electrodes into the brain of a patient with glioblastoma, a fast-growing brain cancer. It will stimulate and read neural activity with high precision so that other parts of the brain are not damaged when the cancer is removed. The implant is removed after surgery.
“We are using the interface to delineate where the glioblastoma is and resect it (cut it out) without affecting functional areas such as language or cognition,” explains Carolina Aguilar, co-founder and CEO of Inbrain Neuroelectronics, a Barcelona-based company that developed the implant together with the Catalan Institute of Nanoscience and Nanotechnology and the University of Manchester.
Platinum and iridium have traditionally been used in implants, but graphene, made from carbon, is ultra-thin, harmless to human tissue and capable of being decoded and modulated very selectively.
Inbrain plans to conduct clinical trials with a similar implant, powered by artificial intelligence, for people with Parkinson’s disease, epilepsy and speech problems caused by strokes.
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Professor Kostas Kostarelos, Professor of Nanomedicine at the University of Manchester, co-founder of Inbrain and principal investigator of the glioblastoma trial, says the company aims to “develop a smarter implantable system.”
The AI-powered devices, with 1,024 electrical contacts, “will help deliver the best therapy for each patient without neurologists needing to program all these contacts individually, as they do today,” he says.
Inbrain is collaborating with German pharmaceutical company Merck to use its graphene device to stimulate the vagus nerve, responsible for several bodily functions including digestion, heart rate and breathing, to treat serious chronic inflammatory, metabolic and endocrine diseases such as rheumatoid arthritis.
Galvani Bioelectronics, founded in 2016 by Britain’s second-largest pharmaceutical company GSK and Alphabet subsidiary Verily Life Sciences, has a leading therapy that aims to treat rheumatoid arthritis by stimulating the splenic nerve. Galvani has begun clinical trials with patients in the UK, US and the Netherlands, with initial results expected within six to 12 months.
The bioelectronics market, which fuses biological science and electrical engineering, is currently worth $8.7bn and is forecast to reach more than $20bn (£15bn) by 2031. According to verified market researchThis area focuses on the peripheral nervous system, which carries signals from the brain to organs and vice versa. Add to this brain-focused neuromodulation and BCI, and the total market could be worth more than $25 billion, Aguilar believes.
While neuromodulation companies in the US have been making waves with devices targeting chronic pain and sleep apnea, there are a growing number of startups in Europe. MintNeuro, a spin-out from Imperial College London, is working on next-generation chips which can be combined into small implants and is collaborating with Amber. Funded by a grant from Innovate UK, their first project is to develop an implant to treat mixed urinary incontinence.
Geneva-based company Neurosoft has developed devices in the form of thin metal sheets on elastic silicone, which are soft and exert less pressure on the brain and blood vessels. They are intended to treat severe tinnitus, which affects 120 million people worldwide.
Nicolas Vachicouras, its chief executive, says: “While tinnitus often begins with damage to the ears, usually due to loud noises… it can cause changes in the wiring of the brain and develop into a neurological disorder.”
Newronika, founded in 2009 by 13 neurosurgeons, neurologists, engineers and other scientists from the Policlinico Milano research centre and the University of Milan, has developed a rechargeable deep brain neurostimulator to treat Parkinson’s disease. It is capable of closed-loop stimulation, which adapts moment by moment to the patient’s condition, and is still being tested on patients.
“When it comes to getting therapies into the NHS and delivering them globally, Europe and the UK can compete head-to-head with the US,” Denison said. “It’s a fair race and we’re going to fight for it.”