Extract

Background and study aims Around one in 40 children in the UK have attention deficit hyperactivity disorder (ADHD). Children with ADHD tend to be hyperactive and impulsive, and have a short attention span, meaning they are easily distracted. They can’t control this behaviour very well, which can seriously impact life at home and at school. This study is investigating the potential of a new, drug-free approach to treatment, which combines a specially designed brain-training video game with electrical brain stimulation. The need for a new treatment that offers long-term benefits for children with ADHD without causing side effects is high. There's no cure for ADHD. Stimulant medication is so far the best working treatment for ADHD, as it improves symptoms in over 70% of patients. However, although medication is often highly effective in the short term, there is little evidence that it helps in the longer term and benefits are immediately lost if children stop taking their medication. What’s more, medication can have side effects, it doesn’t work for everyone, it is disliked by many teenagers and the long-term effects on the developing brain are unknown. Safer and more effective drug-free treatments would be highly desirable. This study is investigating whether a possible new, drug-free approach to treatment might benefit children with ADHD. Who can participate? Boys aged 10-17 with ADHD What does the study involve? The treatment involves playing a specially designed video game while receiving what’s called transcranial direct current stimulation (tDCS). The video game is designed to help children to become less impulsive and more able to pay attention without being distracted. tDCS involves stimulating underactive areas of the brain with weak electric currents – using electrodes placed on the scalp – and the researchers are investigating whether it enhances the effects of the video game with a group of ADHD boys. The study involves the patient being trained every day for 3 weeks for 20 minutes on a computer game that trains his attention and is aimed to make the child less impulsive. At the same time that the child plays on the computer game, he receives a stimulation of the right frontal part of his brain via tDCS. tDCS is considered safe, does not hurt and has no side effects (expect for mild transient tingling in some people). The stimulation of the right frontal part of the brain is thought to help the child to activate these regions and this is thought to improve the ability to concentrate and to make him less impulsive. The children are randomly allocated to receive either real stimulation or fake stimulation. Before and after the treatment, the parents have to fill in questionnaires about the behaviour of their child so the study can test whether the child improves in his ADHD behaviours after the 3 week treatment. In addition the child is tested to see whether he becomes better in typical tests of attention, concentration and impulsiveness. The parents also have to fill in some questionnaires 6 months after the treatment, to test whether the effect of the treatment stays after 6 months. What are the possible benefits and risks of participating in the research? It is not known whether the treatment will make ADHD children better. Some studies have shown that children with ADHD can become better when they are trained in these specific computer games that are aimed at improving their inattention and impulsivity. What’s more, some studies have shown that children with ADHD improve even more in their attention and become less impulsive when they receive brain stimulation together with the video-game. It is thought that children will improve with the treatment but this cannot be guaranteed. Participating in the study therefore may or may not improve ADHD behaviours. Participation in the study will help with the development of a new potentially effective drug-free treatment for ADHD. tDCS is a painless procedure. There are no known risks or side effects of tDCS. The physical sensations are mild, and many participants report being unaware of the stimulation. Some participants report a slightly tingling sensation, and on occasion, participants may report mild local discomfort at the electrode sites, which fades quite quickly as the scalp adapts to the sensations. Where is the study run from? King's College London (UK) When is the study starting and how long is it expected to run for? April 2017 to March 2020 Who is funding the study? Action Medical Research (UK) Who is the main contact? Prof. Katya Rubia

Inclusion criteria

• Attention-Deficit/Hyperactivity Disorder (ADHD)

Links

• isrctn