ohKnowlson, a British teenager with a severe type of epilepsy called Lennox-Gastaut syndrome, became the first person in the world to test 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 has prevented him from falling and injuring himself that he used to have,” said Martin Tisdall, a consultant pediatric neurosurgeon at Great Ormond Street Hospital (Gosh) in London, who have the device implanted. . “His mother talked about how he had such an improvement in his quality of life, but also in his cognition: he’s more alert and more engaged.”
Oran’s neurostimulator sits under the skull and sends constant electrical signals deep into his brain with the goal of blocking abnormal impulses that cause seizures. The implant, which is called a Picostim and is about the size of a mobile phone battery, is recharged via headphones and works differently between day and night.
“The device has the ability to record from the brain, to measure brain activity, and that allows us to think about ways we can use that information to improve the effectiveness of the stimulation the children are getting,” said Tisdall. “What we really want to do is deliver this treatment on the NHS.”
As part of a pilot, three more children with Lennox-Gastaut syndrome will be fitted with the implant in the coming weeks, followed by a full trial with 22 children early next year. If all goes well, the academic sponsors – Gosh and University College London – will apply for regulatory approval.
Tim Denison – a professor of engineering science at Oxford University 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 in four to five years, and around the world.
The technology is part of a growing number of neural implants being developed to treat a wide range of conditions, including brain cancer, chronic pain, rheumatoid arthritis, Parkinson’s, incontinence and tinnitus. These devices are more sophisticated than previous implants in that they not only decode the brain’s electrical activity, but regulate it. It is also a sector in which Europe is taking on the US in a race to develop the life-changing technology.
Amber is not the only company working on brain implants to treat epilepsy. California-based NeuroPace has developed a device that responds to abnormal brain activity and has been approved by the US regulator for those over 18. However, the battery is not rechargeable and must be replaced with surgery after a few years. Other devices are placed in the chest, with wires running to the brain, and must be fitted as a child grows.
Mention brain chips and most people think of Elon Musk’s startup Neuralink, also based in California. It has just implanted a brain chip in a second person with a spinal cord injury. The device uses tiny wires that are thinner than a human hair to pick up signals from the brain and translate them into actions.
The implant was adjusted after a number of the wires moved out of position in the first person to receive it in January, Noland Arbaugh, who was paralyzed from the neck down. It allowed him to control a mouse cursor on a computer screen by thinking, which he said felt like a Star Wars Jedi “use the Force”.
Other American 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 those implants simply decode electrical signals. By contrast, a number of US, UK and European companies, such as Amber, are working to modulate the signals in what are called “BCI therapeutics” – or deep brain stimulation to treat diseases. Amber’s implant is also 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 also sponsored an initial trial in Belgium for the treatment of incontinence, with promising results.
Another type of technology will be tested in humans in a clinical trial starting in a few weeks, with the first brain implant made of graphene. the “wonder material” discovered two decades ago at Manchester University.
A medical team at Salford Royal Hospital will place a device with 64 graphene electrodes on 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 cut out. The implant is removed after the operation.
“We use the interface to determine where the glioblastoma is, and to remove it [cut it out] without affecting functional areas such as language or cognition,” says 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 Manchester University.
Traditionally, platinum and iridium have been used in implants, but graphene, made of carbon, is ultrathin, not harmful to human tissue and can decode and modulate 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.
to newsletter promotion
Prof Kostas Kostarelos, who is the chair of nanomedicine at the University of Manchester, as well as a co-founder of Inbrain and lead trial investigator for the glioblastoma trial, says the company aims to “develop a more intelligent implantable system”.
AI-powered devices with 1,024 electrical contacts will “help deliver the best therapy for each patient without the neurologists having to program all these contacts individually, as they do today,” he says.
Inbrain is working with German pharmaceutical firm Merck to use its graphene device to stimulate the vagus nerve, which is responsible for various body functions including digestion, heart rate and breathing, to treat serious chronic inflammatory, metabolic and endocrine diseases such as rheumatoid arthritis.
Galvani Bioelectronics, set up in 2016 by Britain’s second largest pharmaceutical firm, GSK, and Alphabet subsidiary Verily Life Sciences, has a lead therapy aimed at treating rheumatoid arthritis by stimulating the splenic nerve. Galvani has started clinical trials with patients in the UK, the US and the Netherlands, and first results are expected within six to 12 months.
The bioelectronics market, which fuses biological science and electrical engineering, is now worth $8.7 billion and is expected to reach more than $20 billion (£15 billion) by 2031, according to Verified Market Research. This area focuses on the peripheral nervous system, which carries signals from the brain to the organs and back. Add in 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 made headlines with devices targeting chronic pain and sleep apnea, there is a growing number of startups in Europe. MintNeuro, a spinout from Imperial College London, working on the next generation of chips which can be combined in small implants, and partners with Amber. Funded by an Innovate UK grant, his first project is to develop an implant to treat mixed urinary incontinence.
Neurosoft in Geneva has developed devices in the form of thin metal films on stretchable silicone which, because they are soft, put less pressure on the brain and blood vessels. It targets severe tinnitus, which affects 120 million people worldwide.
Nicolas Vachicouras, its CEO, says: “Although tinnitus often begins with damage to the ears, typically as a result of loud noise…it can cause changes in the brain’s wiring and actually become a neurological disorder.”
Founded in 2009 by 13 neurosurgeons, neurologists, engineers and other scientists from Milan’s Policlinico Research Center and the University of Milan, Newronika 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 in patients.
“When it comes to getting therapies into the NHS and distributed globally, Europe and the UK can go head to head with the United States,” says Denison. “It’s a fair race and we’re going to go for it.”
