London, UK — A major European clinical study, EASEE4YOU, which is assessing a minimally invasive neurostimulation approach for adolescents whose focal epilepsy has not responded to medication, is beginning in the UK, with Great Ormond Street Hospital (GOSH) joining the research programme.
The study is evaluating the EASEE® System, a neurostimulation technology designed to modulate brain activity associated with seizures. The system is already CE-marked for adult patients, and this study represents its first structured clinical assessment in adolescents aged 12 to 17.
Drug-resistant focal epilepsy can significantly affect the daily lives of young people and their families. EASEE4YOU is intended to gather clinical data on the safety and performance of the EASEE® System in an adolescent population, with the aim of understanding whether the therapy may offer an additional option for individuals who have not benefited from existing treatments.
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 contribute to a better understanding of potential future options for improving the lives of these young people.”
The EASEE® System delivers targeted electrical pulses intended to influence neural activity involved in seizure pathways. The device consists of a small pulse generator implanted under the skin of the chest and a thin electrode positioned beneath the scalp on top of the skull. The technique avoids the need to open the skull bone. The system is designed to provide continuous neuromodulation, and the study will evaluate its safety and performance in this age group.
EASEE4YOU is a single-arm, prospective, interventional, unblinded, multicentre study enrolling adolescents aged 12–17 across European sites in Germany, Austria, and the UK.
After a baseline period, participants undergo implantation of the EASEE® System, with the device activated one month later. Follow-up visits are planned through 36 months to assess safety, performance, and changes in seizure frequency over time. The study began enrolling participants in 2023.
As the study continues, data collected from participating European centres will contribute to a growing understanding of how the EASEE® System performs in clinical use. These insights may help inform future research and development for patients with drug-resistant epilepsy.
Karl Stoklosa, CEO of PRECISIS, said: “We welcome the involvement of Great Ormond Street Hospital in the EASEE4YOU programme. Adolescents living with drug-resistant focal epilepsy have limited treatment options, and further research is important to understand whether minimally invasive neuromodulation may offer benefits for this group. This study is an important step in generating clinical evidence that can help guide future therapeutic approaches.”
“Our objective is to support the collection of robust data together with leading clinicians across Europe. The participation of GOSH and other centres strengthens the collaborative effort to improve understanding and explore potential treatment pathways for young people with limited alternatives.”
