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Clinical Trials/ISRCTN48265228
ISRCTN48265228
Unknown
未知

A novel brain-based therapy for attention deficit hyperactivity disorder children using transcranial direct current stimulation combined with cognitive training

King's College London0 sites50 target enrollmentDecember 31, 2016

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
King's College London
Enrollment
50
Last Updated
4 years ago

Overview

Brief Summary

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

Registry
who.int
Start Date
December 31, 2016
End Date
March 2, 2021
Last Updated
4 years ago
Study Type
Interventional
Sex
Male

Investigators

Eligibility 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:

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

Outcomes

Primary Outcomes

Not specified

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