TNS in children with ADHD
Research type
Research Study
Full title
A multi-centre, blinded, randomized, parallel-group, phase IIb study to compare the efficacy of real versus sham Trigeminal Nerve Stimulation (TNS) on symptoms in youth with Attention Deficit Hyperactivity Disorder
IRAS ID
299703
Contact name
Katya Rubia
Contact email
Sponsor organisation
King’s College London
Duration of Study in the UK
3 years, 8 months, 0 days
Research summary
ADHD consists of problems with poor attention, impulsivity, and hyperactivity and affects 7% of children. Treatment is with stimulant medication. However, this has side effects. Non-drug treatments with fewer side effects would be preferred.
The first non-drug ADHD treatment device was approved for its safety in 2019 by the USA Food and Drug administration (FDA), called external trigeminal nerve stimulation (TNS). TNS is a battery charged device that sends small electrical currents under the skin on the forehead and can be applied during sleep. TNS activates the trigeminal nerve on the forehead which leads to the activation of brain regions that are important for arousal and attention.
A pilot study in 62 children with ADHD showed improvement of ADHD symptoms after 4 weeks of TNS compared to placebo (fake, with no electrical currents) TNS after it was used every night with children by their parents for 4 weeks, with minimal side effects.
In our study, we therefore want to further confirm in a large group of 150 children and adolescents with ADHD tested in London and Southampton Universities whether TNS improves ADHD symptoms, whether it improves academic abilities (e.g., attention), whether the effects are still observed 6 months later and how it works on the brain. For this purpose, we will randomise 75 patients to TNS, and another 75 patients to placebo TNS treatment, to test whether TNS is better than placebo TNS in improving parent and teacher-rated ADHD symptoms and cognitive performance in tests of self-control and attention. To understand how it works in the brain we will use functional magnetic resonance imaging (fMRI) to test effects of TNS on the brain function of ADHD children in a subgroup of 56 patients. Furthermore, we will test whether TNS has side effects and whether effects continue 6 months after treatment.REC name
West Midlands - Solihull Research Ethics Committee
REC reference
21/WM/0169
Date of REC Opinion
20 Sep 2021
REC opinion
Further Information Favourable Opinion