Attention Deficit Hyperactivity Disorder (ADHD) Mental and Behavioural Disorders Disturbance of activity and attention
Conditions
Interventions
Updated 24/04/2020: Current interventions as of 24/10/2017:
Patients are randomised (1:1 block randomisation) to the active group or the control group.
Patients in the active group will undergo fMRI-
Sponsors
King's College London (UK)
Eligibility
Sex/Gender
Male
Age
10 Years to 18 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 05/10/2020: ADHD symptom severity, measured using the ADHD Rating Scale (ADHD-RS) at baseline, after the 2 weeks treatment and 6 months after the trial Previous primary outcome measures: ADHD symptom severity, measured using the ADHD Rating Scale (ADHD-RS) at baseline, after the 2 weeks treatment and 6 months after the trial Main fMRI neurofeedback outcome measure: Monotonic change in activation of the right inferior prefrontal cortex that is being upregulated, measured across the 4 fMRI Neurofeedback hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 05/10/2020: 1. fMRI neurofeedback outcome measure: Monotonic change in activation of the right inferior prefrontal cortex that is being upregulated, measured across the 4 fMRI Neurofeedback hours 2. Parent-rated ADHD severity, measured using the ADHD Index of the Conners Parent Rating Scales (CPRS) at baseline, after the 2 weeks treatment and at 6 months follow-up 3. Other clinical measures: 3.1. Overall general behavioural functioning in children, measured using WREMB-R, Weekly Rating of Evening and Morning Behavior-Revised at baseline and after the 2 weeks treatment 3.2. Irritability Index measured using the Affective Reactivity index (ARI) rated by parents and children (5 min) at baseline, after the 2 weeks treatment, and at 6 months follow-up 3.3. Global measure of impairment (CIS score) measured using the Columbia Impairment Scale (CIS) at baseline and after the 2 weeks treatment 3.4. Scores of subjective experience of mind-wandering measured using the Mind excessive wandering scale (MEWS) at baseline, after 2 weeks treatment, and at 6 months follow-up 4. Motor and interference inhibition, sustained attention, vigilance, visual-spatial working memory, Wisconsin Card Sorting Switching task, measured using a cognitive task battery for ADHD at baseline, after the 2 weeks treatment and 6 months after the treatment 5. General side effects measured using side effects and adverse effects measures (5 min) at baseline and after the 2 weeks treatment. The adverse effects measure is measured after the 2 weeks treatment and is specifically measuring any adverse effects the patients may have noticed and which they think is due to the treatment specifically 6. Brain activation in response to a task of motor inhibition in the fMRI scanner, measured using fMRI activation and performance in an fMRI Stop task at baseline, before the first neurofeedback run and after the very last neurofeedback run, after the 2 weeks treatment 7. Long-term | — |
Countries
England, United Kingdom
Outcome results
None listed