fMRI neurofeedback as a novel treatment for children with attention deficit hyperactivity disorder (ADHD)

Not Applicable

Completed

• Conditions: Attention Deficit Hyperactivity Disorder (ADHD); Mental and Behavioural Disorders; Disturbance of activity and attention

• Registration Number: ISRCTN14491589
• Lead Sponsor: King's College London (UK)

Brief Summary

Preprint results see attached file 33852 Preprint results.pdf (added 12/08/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-30
• Study Completion: 2021-06-01
• Last Update Posted: 22 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 94

Inclusion Criteria

Updated 24/04/2020: Current inclusion criteria as of 24/10/2017:
1. Age range: 10-18 years
2. Gender: male
3. Meeting DSM-5 diagnosis of ADHD
4. Score above clinical cut-off on the Schedule for Affective Disorders and Schizophrenia, ADHD module (K-SADS)(Kaufman et al., 1996)
5. Score about clinical cut-off for ADHD on the short forms of the Conners Parent Rating Scale (CPRS) (Conners et al., 1998)
6. Patients will be either medication naïve or on their usual stable medication without change in regime throughout the study; they will be taken off their medication for the cognitive pre and post or follow-up assessments 24 hours which is optional
7. IQ > 80 as tested on the 4 subtests of the WASI (Wechsler, 1999) that assesses intellectual ability of individuals aged 6 years and over. Administration of 4 subtests takes ~ 40 minutes, and produces a full-scale IQ score
8. Score below clinical cut-off on the Social Communications Questionnaire (SCQ) (Rutter et al., 2003)

Previous inclusion criteria:
1. Age range: 10-18 years
2. Gender: male
3. Meeting DSM-5 diagnosis of ADHD
4. Score above clinical cut-off on the Schedule for Affective Disorders and Schizophrenia, ADHD module (K-SADS)(Kaufman et al., 1996)
5. Score about clinical cut-off for ADHD on the short forms of the Conners Parent and Teacher Rating Scales (CPRS/CTRS) (Conners et al., 1998)
6. Patients will be either medication naïve or on their usual stable medication without change in regime throughout the study
7. IQ > 80 as tested on the 4 subtests of the WASI (Wechsler, 1999) that assesses intellectual ability of individuals aged 6 years and over. Administration of 4 subtests takes ~ 40 minutes, and produces a full-scale IQ score

Exclusion Criteria

1. IQ < 80 (Wechsler et al., 1999)
2. Comorbidity with any other major psychiatric disorder such as schizophrenia, autism, bipolar disorder, learning disability, severe depression with current suicidal behaviour (as assessed by clinician). Mood problems and anxiety will be allowed if they are not the primary diagnosis
3. Neurological problems, i.e. a history of severe neurological illness, e.g. brain tumour, epilepsy or a history of symptomatic seizures, polyneuropathy etc
4. Alcohol and substance abuse history
5. Contraindication to fMRI. i.e., previous implantation of metallic material, pacemaker, implanted medication pumps, neural stimulators, or claustrophobia
6. Unable to give informed consent of the child and parent

Study & Design

• Study Type: Interventional
• Study Design: Not specified