fMRI neurofeedback as a novel neurotherapy for children with attention deficit hyperactivity disorder (ADHD): a randomised controlled trial
Attention Deficit Hyperactivity Disorder (ADHD)
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-Neurofeedback to learn to upregulate their own brain activation in right inferior prefrontal cortex in 15 sessions of 7.5 minutes each. This will be done over 4 MRI sessions of 60 min duration each over 2 weeks. Within each MRI session there will be 2-5 runs of fMRI-Neurofeedback of 8.5 minutes each. A sham fMRI Neurofeedback condition will be administered to the control group with the same number of runs as the active group. Feedback for the sham Neurofeedback group will be from another person from the active group. Patients will be tested before and after the treatment in clinical ADHD severity measures, in cognitive tests of attention and self-control, in their brain activation in response to a task of self-control, and in measures of side-effects. Clinical severity symptoms and cognitive performance will also be measured 6 months after the neurofeedback to test whether the benefits persist longer-term. Previous interventions: Patients are randomised (1:1 block randomisation) to the active group or the control group. Patients in the active group will undergo fMRI-Neurofeedback to learn to upregulate their own brain activation in right inferior prefrontal cortex in 14 sessions of 8.5 minutes each. This will be done over 4 MRI sessions of 70 min duration each over 2 weeks. Within each MRI session there will be 3-4 runs of fMRI-Neurofeedback of 8.5 minutes each. A sham fMRI Neurofeedback condition will be administered to the control group with the same number of runs as the active group. Feedback for the sham Neurofeedback group will be from another person from the active group. Patients will be tested before and after the treatment in clinical ADHD severity measures, in cognitive tests of attention and self-control, in their brain activation in response to a ta
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
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