Multi-centre study led by Professor Katya Rubia will look at look this alternative, non-drug treatment for children with ADHD
National Institute for Health Research (NIHR) funding of £1,884,882.42 has been awarded to a research team led by Professor Katya Rubia, to study whether external Trigeminal Nerve Stimulation is an effective treatment for Attention Deficit Hyperactivity Disorder (ADHD).
ADHD is a neurodevelopmental disorder affecting 7% of children worldwide. Treatment for ADHD is with stimulant medication, which has side effects, does not work for everyone, and has limited longer-term effects. An effective non-drug treatment for ADHD with minimal side effects that can be administered at home would have the potential to improve the healthcare and reduce the strain of the disease for patients. However, most non-drug treatments have shown little effects.
External trigeminal nerve stimulation (eTNS) is the first non-drug ADHD treatment device approved (in 2019) by the USA Food and Drug administration (FDA). eTNS is a battery charged device that sends small electrical pulses or currents under the skin, activating the trigeminal nerve on the forehead which leads to the activation of the brain stem and frontal brain regions that are important for arousal and attention.
The multi-centre study will explore eTNS’ potential in improving parent and teacher-rated ADHD symptoms and cognitive performance in tests of self-control and attention. The study will use functional magnetic resonance imaging (fMRI) to test effects of eTNS on the brain function of ADHD children in a subgroup of patients. Finally, it will test whether eTNS has side effects and whether effects continue 6 months after treatment.
I am very excited about this award from the NIHR. The study will confirm whether eTNS is an effective non-drug treatment for ADHD behaviour that has minimal side effects and can be administered in-house and hence is likely to be preferred by patients, parents, and clinicians. Such a treatment would improve the healthcare and disease burden for patients– Professor Katya Rubia, Chief Investigator of the study
The Primary Investigators on this study are Professors Katya Rubia & Paramala Santosh. Co-investigators are Dr Ben Carter, Miss Andrea Bilbow (CEO ADDISS), Professor Mitul Mehta and Professor Samuele Cortese. Representatives of public advisory groups, the Lambeth ADHD Support group (parents/clinicians), the Young Person Mental Health Advisory Group (YPMHAG), FAST-R (service user groups), ADDISS (national ADHD support service), and ADHD Richmond & Kingston UK were all involved in the study design and are represented on trial management and steering committees.
The study is due to begin in September 2021, finishing in May 2025.