The landmark European clinical study EASEE4YOU, evaluating a pioneering neurostimulation therapy for adolescents with drug-resistant focal epilepsy, is set to launch in the UK, with Great Ormond Street Hospital (GOSH) joining the research programme.
The study evaluates the EASEE System, a minimally invasive brain stimulation technology designed to reduce seizure frequency in adolescents who have not responded to at least two anti-seizure medications. While EASEE received CE approval for adults in 2022, this marks the first time the therapy is being systematically tested in adolescents aged 12 to 17.
Focal epilepsy that does not respond to medication can severely affect the quality of life for young people and their families. The EASEE4YOU study aims to provide the clinical evidence needed to secure market approval for the technology’s use in adolescents, offering new hope to young patients for whom existing treatments have been unsuccessful.
Mr Martin Tisdall, Consultant Paediatric Neurosurgeon at Great Ormond Street Hospital said: “We’re pleased to be joining this research programme, as at Great Ormond Street Hospital we see first-hand the impact treatment-resistant epilepsy has on young people and their families. Taking part in the EASEE4YOU study allows us to explore a minimally invasive therapy and we hope this research will pave the way for safer, more effective solutions that improve quality of life for these young people.”
EASEE is an innovative neurostimulation device designed to deliver continuous, targeted electrical pulses to modulate brain activity associated with seizures. Unlike traditional deep brain stimulation, EASEE uses a less invasive approach with a thin electrode placed just beneath the scalp and a pulse generator implanted in the chest.
This system provides long-term brain stimulation, aiming to reduce seizure frequency and improve quality of life for patients living with epilepsy. To date, more than 150 adult patients have received EASEE® implants across Germany, Austria, Switzerland, the UK, Italy and Portugal. This milestone reflects rising clinical confidence and broader adoption by leading epileptologists and neurosurgeons.
EASEE4YOU is a single-arm, prospective, interventional, unblinded, multicentre study, collecting data on 35 adolescents aged 12–17 across clinical sites in Germany, Austria, and the UK. Following a two-month baseline period, participants undergo implantation of the EASEE System, the device being activated one month after surgery. Patients are then monitored through regular follow-up visits for up to three years post-implantation. The primary endpoint of the study is the proportion of participants achieving at least a 50% reduction in seizure frequency after six months of stimulation.
“We are proud to see the EASEE4YOU study expand to the United Kingdom with the involvement of Great Ormond Street Hospital – one of the world’s foremost centres for paediatric neuroscience. For adolescents living with drug-resistant focal epilepsy, treatment options are far too limited, and the burden on young people and their families can be profound. By evaluating our minimally invasive EASEE System in this age group for the first time, we are taking an important step toward offering a safe, effective therapy to patients who have exhausted conventional treatments”, said Karl Stoklosa, CEO of PRECISIS, the company behind EASEE.
“Our goal is to generate the robust clinical evidence needed to bring this technology to adolescents across Europe. The commitment of leading clinicians at GOSH and other participating sites strengthens our confidence that together we can advance a new era of care – one that provides hope, meaningful seizure reduction, and an improved quality of life for young people who desperately need better options.”
Initial results from the study are expected to be available in 2027.
