Condition category
Mental and Behavioural Disorders
Date applied
12/03/2012
Date assigned
27/03/2012
Last edited
19/01/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

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 measures

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 Children’s Global Assessment Scale (CGAS), a clinical rating scale used to document children’s 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

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

http://www.kcl.ac.uk/iop

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

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

19/01/2016: Plain English summary added