Attention deficit hyperactivity disorder (ADHD) Mental and Behavioural Disorders Disturbance of activity and attention
Conditions
Interventions
Updated 01/05/2020: current interventions since REC approval 18/07/2017:
Transcranial direct current stimulation (tDCS) (1mA) combined with cognitive training on ADHD-relevant computer
Sponsors
King's College London
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Updated 12/05/2020: current inclusion criteria since ethics approval on 18/07/2017: 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) 5. Score about clinical cut-off for ADHD on the short forms of the Conners Parent Rating Scales (CPRS) 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 Comorbidity with other disorder will be allowed except the ones outlined below under exclusion criteria Previous inclusion criteria: 1. Age range: 10-17 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) 5. Score about clinical cut-off for ADHD on the short forms of the Conners Parent and Teacher Rating Scales (CPRS/CTRS) 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 Comorbidity with other disorder will be allowed except the ones outlined below under exclusion criteria
Exclusion criteria
Exclusion criteria: 1. IQ < 80 2. Comorbidity with schizophrenia, Bipolar disorder, learning disability, severe depression with current suicidal behaviour (as assessed by clinician) 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. Substance abuse history 5. Contraindication to neurostimulation. i.e., previous implantation of metallic material (e.g., vascular clips, cochlear implant) in the cranium (except in the mouth), pacemaker, implanted medication pumps, neural stimulators 6. Drug treatment acting primarily on the central nervous system which lowers the seizure threshold such as antipsychotic drugs (chlorpromazine, clozapine) or tricyclic antidepressants 7. Diseased or damaged skin over the face or scalp 8. History of migraine (brain stimulation may increase susceptibility to headaches in migraineurs) 9. Unable to give informed assent or consent in the case of the primary caregiver
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Updated 01/05/2020: current primary outcome measures since ethics approval on 18/07/2017: Measured immediately before and after the intervention and 6 months after the intervention: 1. Cognitive performance outcome variables, measured using a cognitive task battery developed for ADHD that measures key functions typically impaired in the disorder including motor inhibition (Go-no-go task) and sustained attention (Continuous Performance Task). 2. ADHD symptoms, measured on the ADHD-Rating Scale (ADHD-RS) Previous primary outcome measures: Measured immediately before and after the intervention and 6 months after the intervention: 1. Cognitive performance outcome variables, measured using a cognitive task battery developed for ADHD that measures key functions typically impaired in the disorder including motor and interference inhibition, switching, sustained attention, time estimation, and temporal discounting 2. ADHD symptoms, measured on the ADHD-Rating Scale (ADHD-RS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Updated 01/05/2020: current secondary outcome measures since ethics major amendment 21/11/2017: Measured immediately before and after the intervention: 1. The ADHD Index of the Conners Parent Rating Scales (CPRS) 2. Other clinical measures: 2.1. The Columbia Impairment Scale (CIS) 2.2. The WREMB-R, Weekly Rating of Evening and Morning Behavior-Revised 2.3. The Affective Reactivity Index (ARI) 2.4. The Mind excessive wandering scale (MEWS) 3. Side effects 4. Other cognitive measures: 4.1. Wisconsin Card Sorting Test (WCST) 4.2. Vigilance task 4.3. Simon Interference inhibition task 4.4. Time estimation task 4.5. Visual-spatial working memory task 4.5. Verbal and semantic fluency task 5. EEG measures at pre and post assessment and follow-up during rest and Go-no-go task (10min) 6. Long-term effects, assessed 6 months after the intervention in the primary outcome measures, in the CPRS, ARI, MEWS and in all cognitive tasks Previous secondary outcome measures: Measured immediately before and after the intervention: 1. The ADHD Index of the Conners Parent Rating Scales (CPRS) 2. Other clinical measures: 2.1. Clinical Global Impression ADHD severity scale (CGI) 2.2. The Columbia Impairment Scale (CIS) 2.3. The Child Health Questionnaire 3. Side effects 4. Long-term effects, assessed 6 months after the intervention in the primary outcome measures | — |
Countries
United Kingdom
Outcome results
None listed