Category: Healthcare & Medical
Project: The Children’s Adaptive Deep brain stimulation for Epilepsy Trial (‘CADET’)
Partners: Department of Neurosurgery, Great Ormond Street Hospital with Amber Therapeutics Ltd, Institute of Biomedical Engineering, University of Oxford; Medical Research Council Brain Network Dynamics Unit, University of Oxford; Department of Basic and Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience, King’s College London
Last year, UK clinicians hailed a potentially huge breakthrough in the treatment of childhood epilepsy, with the news that a clinical trial of a pioneering brain implant had apparently transformed the life of a British teenager suffering from one of the severest forms of the illness.
According to initial reports, since having the device fitted in October 2023 at London’s Great Ormond Street Hospital, thirteen-year-old Oran Knowlson (who suffers from a hitherto treatment resistant form of epilepsy known as Lennox-Gastaut syndrome) has seen an 80 per cent reduction in daytime seizures, which previously sometimes occurred hundreds of times a day and required frequent hospitalization.
The development is the latest in a series of trials taking place through the UK’s CADET project (The Children’s Adaptive Deep brain stimulation for Epilepsy Trial) a clinical-industry collaboration aimed at investigating the safety, feasibility and effectiveness of a novel UK-developed brain pacemaker (Picostim DyNeuMo) to help and improve the quality-of-life of children with epilepsy.
In recent years there has been growing interest in the use of Deep brain stimulation (DBS) as a therapeutic option for people with severe and complex epilepsy. The treatment typically involves the insertion of electrodes into predefined targets within the brain (such as the thalamus) that are involved in seizure generation or spread. It works by modulating the electrical brain activity in the thalamus to prevent epileptic activity spreading from one brain region to another thus preventing seizure activation.
It all boils down to a common mission statement, and that mission statement is developing technology that’s going to help patients, and that’s what we all rally around.
However, whilst trials have demonstrated its effectiveness for reducing seizures in adults there have -until now - been no robust studies that have demonstrated its effectiveness for treating childhood epilepsy.
One of the key reasons for this is that all commercially available DBS devices have been developed in adults and are therefore not optimised for paediatric use.
For instance, current devices have wires that insert into the brain and connect to an internal battery that is inserted in the chest wall. For children, this is a problem, since they will literally ‘outgrow’ their device, and the connecting wires will become tight, broken or sore. The batteries themselves require surgical replacement approximately every 3 – 5 years, which again has major ramifications for a child with 60-80+ year’s worth of battery changes ahead of them.
Current devices also limit stimulation settings to a static ‘one-size-fits-all’ regime that doesn’t adapt for an individual child’s seizure phenotype or circadian seizure patterns (such as nocturnal seizures).
Developed by Oxford University spin-out Amber Therapeutics, the Picostim system at the heart of the CADET project addresses these issues by using an entirely cranially-mounted system that is not affected by a child’s growth and a rechargeable battery that can be powered up with a non-invasive induction charger.
It also has the capability to schedule therapy according to time-of-day and can even - sense seizure activity developing in the brain and respond with a dose of stimulation that aborts seizure progression. Indeed, the CADET project has now been awarded a £1.4 Million grant by the NIHR Product Development scheme to run a first-of-its-kind trial of adaptive stimulation for paediatric epilepsy using the device.
The success of the CADET project has its foundations in a truly collaborative effort by clinicians, academic engineers and industry underpinned by weekly meetings and regular dialogue between the team members. Indeed, as part of the trial Great Ormond Street hospital acquired honorary contracts at the hospital for the academic engineers, so they could both provide onsite technical support; get feedback from patients and their families, and understand the practicalities of clinical implementation of the therapy.
In such a diverse team, one of the keys to driving collaboration has been ensuring that all of the different partners share a common goal. Commenting on this collaborative dynamic in an earlier article in The Engineer Great Ormond Street Hospital’s Rory Piper, CADET trial fellow and coordinator, said: “It all boils down to a common mission statement, and that mission statement is developing technology that’s going to help patients, and that’s what we all rally around. It doesn’t matter whether we talk in academic, engineering or clinical terms, that’s what we all get behind,”.
The potential societal impact of the advances being made through the CADET trial is huge. Epilepsy affects 1/100 people (600,000+) in the UK, and approximately one third of those patients don’t respond to medications alone. For those patients without any surgical or any other treatment options, such as Oran, this novel and innovative therapeutic strategy provides a chance of meaningful seizure frequency reduction and the opportunity to improve lives.
What’s more, the technology could also help address a huge financial burden for the NHS which currently spends over £1.3 billion per year on epilepsy, not just on therapies, but also on unplanned hospitalizations, emergency medication, ITU care and so on.
The team goal now is to provide solid data to support the adoption of DBS therapy in the UK and to develop a DBS therapy that can be accessed via the NHS.
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