Brain stimulation combined with cognitive training in attention deficit hyperactivity disorder

Not Applicable

• Conditions: Attention deficit hyperactivity disorder (ADHD); Mental and Behavioural Disorders; Disturbance of activity and attention

• Registration Number: ISRCTN48265228
• Lead Sponsor: King's College London

Brief Summary

2021 results in https://pubmed.ncbi.nlm.nih.gov/34225830/ (added 07/07/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-12-31
• Study Completion: 2021-03-02
• Last Update Posted: 21 July 2021

Recruitment & Eligibility

• Sex: Male
• Target Recruitment: 50

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified