EASEE4YOU
Research type
Research Study
Full title
EASEE4YOU – A clinical investigation of the safety and efficacy of transcranial focal cortex stimulation with the EASEE System FOR the treatment of medically refractory focal epilepsy in YOUng patients, aged 12 to 17 years.
IRAS ID
348891
Contact name
Susanne Müller - Scholtz
Contact email
Sponsor organisation
Precisis GmbH
Duration of Study in the UK
3 years, 2 months, 1 days
Research summary
The EASEE4YOU study is testing a medical device called the EASEE System, which is an implant that sends electrical signals to a specific part of the brain to help reduce seizures. It is designed for young people aged 12 to 17 who have focal epilepsy that has not improved with regular treatments. The device has already been tested and approved for use in adults, but this is the first time it is being studied in this age group.
The main goal of the study is to see if the EASEE System helps reduce seizures. This will be determined by assessing whether participants have at least 50% fewer seizures six months after starting the treatment. Further objectives of the study include understanding how often seizures happen and how severe they are; looking at effects on quality of life and mood, and reporting on missed school or work days for the young person or their caregiver. The study will also ascertain how safe the device is — both during the surgery to implant it and while it is being used.
The study will take place at up to 11 hospitals or clinics across Europe and will include 35 young people. Each participant will receive the EASEE System i.e. there is no comparison or placebo group. The study has been designed in a way that is suitable for testing a new treatment in young adolescents for the first time. Because of ethical and practical reasons, it would not be right to include a placebo or sham device. Instead, the study focuses on collecting strong and reliable information about how safe the device is and how well it works. The results will help support future approvals from health authorities and may lead to wider use of the device for young people with epilepsy.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
25/YH/0118
Date of REC Opinion
11 Sep 2025
REC opinion
Further Information Favourable Opinion