fMRI Neurofeedback in children with ADHD
Research type
Research Study
Full title
fMRI Neurofeedback as a novel neurotherapy for children with ADHD
IRAS ID
230303
Contact name
Katya Rubia
Contact email
Sponsor organisation
Research Ethics & Governance Office Exeter University
Duration of Study in the UK
3 years, 6 months, 1 days
Research summary
Stimulant medication is efficacious in ADHD, but has limited longer-term effects, adverse effects, and is not indicated for all patients. Non-pharmacological treatment is preferred, but existing non-pharmacological treatment approaches in ADHD have shown limited efficacy. Neurofeedback uses operant conditioning and trains participants to gain control over specific brain regions by giving them feedback of these brain regions. Participants can learn to enhance the activity of their brain region when they get feedback of these regions by trial and error. EEG-Neurofeedback (EEG-NF) has been used in ADHD for over 50 years, but has only shown moderate effects. fMRI-NF has much faster training effects relative to EEG-NF and our preliminary findings are promising. Our pilot feasibility study in 31 ADHD children (IRAS reference number: 100848; REC NR: 12/LO/0708 REC Camberwell St Giles) showed that children with ADHD can learn to enhance the activity of a brain region that is typically impaired in ADHD, right inferior frontal cortex, with fMRI-NF training. Furthermore learning to enhance this frontal region with the NF training was associated with short and longer-term clinical improvements after 11 months, with better attention skills and with better brain activity in tests of self-regulation. Furthermore there were no side or adverse effects. The evidence for a new non-drug treatment for ADHD based on brain self-regulation with no side is hence promising. However, in our pilot study we compared two active NF conditions, and could not rule out placebo effects. Also, the study was only single-blind. It is hence paramount to compare fMRI-NF with sham fMRI-NF to rule out placebo effects that are non-specific to the NF training in a double-blind placebo-controlled (sham-fMRI-NF) randomized controlled trial in a sizeable and well powered study. In this study we will therefore replicate the study but in a larger group of 100 ADHD boys and use a randomised double-blind placebo controlled design.
REC name
London - Bromley Research Ethics Committee
REC reference
17/LO/1368
Date of REC Opinion
25 Oct 2017
REC opinion
Further Information Favourable Opinion