Neurofeedback in children with attention deficit hyperactivity disorder (ADHD)
| ISRCTN | ISRCTN12800253 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12800253 |
| Secondary identifying numbers | N/A |
- Submission date
- 12/03/2012
- Registration date
- 27/03/2012
- Last edited
- 01/03/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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
Contact information
Scientific
King's College London
Institute of Psychiatry
Department of Child Psychiatry
London
SE5 8AF
United Kingdom
 ORCID ID |
0000-0002-1410-7701 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Neurofeedback using functional magnetic resonance imaging in patients with attention deficit hyperactivity disorder (ADHD) |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/09/2012 |
| Completion date | 01/03/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 12 Years |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2012 |
| Date of final enrolment | 01/03/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
SE5 8AF
United Kingdom
Sponsor information
University/education
Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
England
United Kingdom
| Website | http://www.kcl.ac.uk/iop |
|---|---|
"ROR" |
https://ror.org/0220mzb33 |
Funders
Funder type
Research organisation
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- actionmedres, action medical research for children, AMR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | proof-of concept study results | 01/06/2017 | Yes | No |
Editorial Notes
19/01/2016: Plain English summary added.
28/02/2018: Publication reference added.
01/03/2018:
1. Participant level data changed from 'not available at time of registration' to 'available upon request'
2.. ORCID ID for principal investigator was added in contact information
