A groundbreaking implantable device has shown promising results in significantly reducing the frequency and intensity of seizures in children with severe epilepsy, according to a new clinical trial in the UK. With plans to expand the trial to include more patients, experts hope this revolutionary technology will set a new standard in epilepsy treatment.
Oran’s seizures began two weeks after his third birthday and until surgery when he was 12, he had not had a single day without a seizure. Many in his family have a mutation in the SCNIB gene and have all dealt with seizures and epilepsy, but they now all have control over their seizures.
Sadly, Oran’s epilepsy became more severe and he often stopped breathing and required resuscitation. This meant Oran needed 24-hour care as seizures could happen at any time of the day and he was at significantly higher risk of Sudden Unexpected Death in Epilepsy (SUDEP).
Oran’s mother Justine said: “Before the seizures started, Oran was hitting all his milestones, but as the seizures became more severe, we lost more and more of Oran. From a happy, energetic three-year-old, he struggled to engage with the world due to medication and seizures – but he still has his sense of humor.”
Deep brain stimulation (DBS) is a treatment that involves surgery to insert a small device that stimulates specific parts of the brain.
Unlike other DBS devices that are fitted in the chest with wires running up the neck to the brain, this device is fitted in the skull, meaning the wires are less likely to break or corrode as the child grows.
The CADET Project is using a skull-mounted DBS device called Picostim with software called DyNeuMo-1, manufactured by Bioinduction Ltd. The devices enable personalized and adaptive stimulation regimens based on individual patient seizure patterns and circadian rhythms (wake/sleep), which are key components of epilepsy symptoms. They can limit the spread of seizures and reduce seizure frequency and severity. Patients or parents can use a portable or headset-mounted charger that recharges the battery safely through the skin. Finally, the entire device is mounted on the skull, eliminating the need for (painful) tunneling of extension wires to a battery implanted in the chest wall, potentially reducing the risk of infection.
This device is also rechargeable via wearable headphones, which can be worn while watching a video or interacting with a tablet. This also means that it does not require surgery to replace it every three to five years.
The device targets the thalamus, which is a hub for electrical signals in the brain. It is hoped that the device will block electrical pathways and therefore stop seizures from spreading.
The device also has settings to optimize seizure patterns, which, although not used in this trial, could be used in the future for LGS patients.
Oran underwent surgery in October 2023 to have the device inserted and, once he had recovered from the procedure, the device was ‘switched on’, providing constant electrical stimulation to Oran’s brain.
He was the first child in the UK to have the device implanted at Great Ormond Street Hospital in October 2023. Since then, life has changed completely for Oran and his family.
“He’s much more talkative, more engaged. He’s 13 and I’m a teenager now – he’s happy to say no to me. But it does increase his quality of life when he can express himself better.
Oran after surgery, aged 13
The rechargeable device is fitted to the skull and connected to electrodes deep in the brain to reduce seizure activity. This is the first UK clinical trial measuring this type of treatment for children with epilepsy.
The CADET (Children’s Adaptive Deep Brain Stimulation for Epilepsy Trial) pilot will now recruit three additional patients with Lennox-Gastaut syndrome, which is funded by the Royal Academy of Engineering before 22 patients take part in the full trial, which is being funded by GOSH Charity and LifeArc. The study is sponsored by UCL.
Martin Tisdall, Honorary Associate Professor at UCL and Consultant Paediatric Neurosurgeon at GOSH, said: “Every day we see the life-threatening and life-limiting impacts of uncontrollable epilepsy. It can make school, hobbies or even watching a favorite TV program completely impossible. For Oran and his family, epilepsy has completely changed their lives, so to see him riding and regaining his independence is amazing. We couldn’t be happier to be part of their journey,” said Professor Martin Tisdall, one of the project’s coordinators.
Deep brain stimulation brings us closer than ever to stopping seizures in patients with very limited effective treatment options.
The researchers involved are excited to build the evidence base to demonstrate the ability of deep brain stimulation to treat pediatric epilepsy and hope that within the next few years, it will be a standard treatment they can offer.
Professor Tim Denison, from the University of Oxford and Royal Academy of Engineering Chair in Emerging Technologies, Chief Engineer, said: “Our mission is to design pioneering research systems to explore the treatment of intractable health conditions such as pediatric epilepsy.
Oran is the first child in the world to receive this device and we are incredibly pleased that it has had such a positive benefit for him and his family.
“We have tried everything but this is the first real chance we have been given in years, there has been no ‘what next’ until now. Unless someone takes the first step in a trial like this, there will never be a better one and there has to be a better one for our family. The future looks bright, which I wouldn’t have dreamed of saying six months ago. For Oran, having hope brings excitement. It makes the future brighter and even more attainable. I am so happy that Oran will be able to experience this,” Oran’s mother thanked the researchers.
READ MORE:
Comments