ATTENS

ADHD Trial of External Trigeminal Nerve Stimulation (TNS)

A multicenter study for a novel non-pharmacological brain stimulation treatment for ADHD at the Institute of Psychiatry, Psychology & Neuroscience at King's College London & at University of Southampton

Purpose of the ATTENS study

  • Project aims: The ATTENS (ADHD Trial of External Trigeminal Nerve Stimulation, eTNS) project is investigating a novel non-medical treatment for ADHD in children aged 8 to 18 years old.

  • What is the treatment? 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.

  • How does it work? 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.

  • Is it licenced for ADHD? 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.

  • Study details: 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.

What is trigeminal nerve stimulation (TNS)?

  • What is TNS? TNS is a medical device that has a battery with some cables that lead small electrical stimulation to a patch which resembles a large plaster that is placed on the forehead. This patch stimulates the trigeminal nerve which is a nerve that sits on the forehead.

  • Does it work? In a study in the USA, this device has been shown to improve the problems children with ADHD have and we want to test this further.

  • Is it safe? The device is very safe for children. No serious side effects or adverse events have been reported in studies with TNS and we do not expect any major side effects. However, we cannot guarantee that you will not have any side effects and some have complaints about headache (that quickly goes away) or skin irritation (that goes away with cream). Other potential side effects could be fatigue.

In the Media

See the following link for a news article about our study.

New NIHR Funding to explore effects of external Trigeminal Nerve Stimulation in ADHD (kcl.ac.uk)

Funding

The project is funded by the Efficacy and Mechanism program (EME) of the National Institute for Health Research/Medical Research Council (NIHR130077). Trial registration ISRCTN82129325.