The ATTENS (ADHD trial of external trigeminal nerve stimulation) project is investigating a novel non-medical treatment for ADHD in children aged 8 to 18 years old. The treatment consists of a device that stimulates the trigeminal nerve with a small electrical current through a battery charged patch that is put on the child’s forehead when they sleep. The activation of the trigeminal nerve on the forehead leads to the activation of the brain stem and frontal brain regions that are important for arousal and attention. The Monarch eTNS (external trigeminal nerve stimulation) device is approved by the USA Food and Drug administration (FDA) in the U.S.A as the first non-pharmacological treatment for ADHD. The study will test in a large multicentre trial across London and Southampton whether using this device for 4 weeks will improve ADHD behaviours, cognitive skills like attention and self-control and the function of the brain using functional magnetic resonance imaging (fMRI). The study will randomise participants to either the real or the sham device which is like a placebo.
All participants will be assessed before and after the treatment as well as 6 months later in a series of clinical and cognitive measures, safety measures, measures of motion in a wrist-hand device and will also do fMRI if they want but this is optional.
This project is led by Professor Katya Rubia in collaboration with Professor Samuele Cortese, University of Southampton and takes place in London and in Southampton.
Professor Katya Rubia, King's College London
Dr Ben Carter, King's College London
Professor Paramala Santosh, King's College London
Professor Mitul Metha, King's College London
Clinical Trial Manager:
Lena Johansson, King's College London
Professor Samuele Cortese, Centre for Innovation in Mental Health (CIMH), School of Psychology, University of Southampton
Andrea Bilbow OBE, Chief Executive of ADDIS
The project is funded by National Institute for Health Research (NIHR130077). Trial registration ISRCTN82129325.
Recruitment period: Depending on approval, it is expected that recruitment will start in September 2022 and last until the beginning of 2025.