Plain English Summary
Background and study aims
Attention Deficit Hyperactivity Disorder (ADHD) is the most common child psychiatric disorder. It is a group of behavioural symptoms that include inattentiveness, hyperactivity and impulsiveness. The most common treatment is medication, but this has side effects. This study aims to test a new treatment for ADHD called neurofeedback.
Who can participate?
Patients aged between 12 and 18 with ADHD.
What does the study involve?
Participants are randomly allocated to either the intervention group or the control group. Participants in the intervention group undergo neurofeedback, where they are taught to increase the activity of certain brain regions that we know are not functioning well in ADHD. Neurofeedback in these regions will be compared with neurofeedback in other brain regions. This is done in 4 visits over 2 weeks. The control group are asked to do the same but on a different brain region.
What are the possible benefits and risks of participating?
It is expected that patients will benefit from the neurofeedback training as it will improve their ADHD symptoms. There are no known side effects of neurofeedback.
Where is the study run from?
Institute of Psychiatry, King’s College London (UK)
When is the study starting and how long is it expected to run for?
September 2012 to March 2015
Who is funding the study?
Action Medical Research (UK)
Who is the main contact?
Prof. Katya Rubia
Trial website
Contact information
Type
Scientific
Primary contact
Prof Katya Rubia
ORCID ID
http://orcid.org/0000-0002-1410-7701
Contact details
King's College London
Institute of Psychiatry
Department of Child Psychiatry
London
SE5 8AF
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Neurofeedback using functional magnetic resonance imaging in patients with attention deficit hyperactivity disorder (ADHD)
Acronym
Study hypothesis
The hypothesis is that ADHD children will be able to progressively upregulate right frontal cortex and caudate activations in 16 sessions of 10 minutes of fMRI-Neurofeedback and that this upregulation will be associated with an improvement in symptom severity of inattention, hyperactivity and impulsiveness as measured in ADHD behavioural rating scales
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Attention Deficit Hyperactivity Disorder
Intervention
Neurofeedback using functional magnetic resonance imaging (FMRI-NF)
Patients will undergo Neurofeedback to learn to upregulatetheir own brain activation in 16 sessions of 5 minutes each. This will be done over 4 MRI sessions. Within each FMRI session there will be 4 sessions of 5 minutes each. This will be done over 4 visits over 2 weeks.
The control group will be asked the same but on a different brain region.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. The ADHD Rating Scale (ADHD-RS)(Dupaul et al., 1998), measured before and after the treatment
2. Monotonic increase in inferior frontal lobe and caudate activation across the feedback sessions in the active group
Secondary outcome measures
1. Reduction in the ADHD Index of the Conners Parent Rating Scale
2. Reduction in the Childrens Global Assessment Scale (CGAS), a clinical rating scale used to document childrens overall functional capacity at home, school, and with peers
3. No side effects as measured on a side effects scale
IMprovement in a cognitive task battery we have developed for ADHD that measures key functions including inhibition, attention, timing and motivation
Overall trial start date
01/09/2012
Overall trial end date
01/03/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Between the age of 12 and 18 years
2. Score above clinical cut-off on the Schedule for Affective Disorders and Schizophrenia, ADHD module (K-SADS) (Kaufman, Birmaher, Brent, Rao, & Ryan, 1996)
3. Score above clinical cut-off on the Conners Parent and Teacher Rating Scales (CPRS/CTRS) (Conners, Sitarenios, Parker, & Epstein, 1998)
4. Score above cut-off on the ADHD Rating Scale (ADHD-RS) (Dupaul, Power, Anastopoulos, & Reid, 1998).
5. Patients will be either medication naïve or on their usual stable medication without change in regime throughout the study.
6. Comorbidity with other disorder will be allowed except the ones outlined below under exclusion criteria
7. IQ > 80
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
40
Participant exclusion criteria
1. Neurological disorder
2. Epilepsy
3. Drug and alcohol abuse/dependence (as assessed by K-SADS)
4. Comorbidity with schizophrenia, Bipolar disorder, learning disability, severe depression with current suicidal behaviour (as assessed on Kiddie-SADS)
5. IQ < 80
Recruitment start date
01/09/2012
Recruitment end date
01/03/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
King's College London
London
SE5 8AF
United Kingdom
Sponsor information
Organisation
King's College London (UK)
Sponsor details
Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Action Medical Research (UK) ref: 1890
Alternative name(s)
AMR
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
Publication list
2017 proof-of concept study results in: https://www.ncbi.nlm.nih.gov/pubmed/28342214