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临床试验/ISRCTN48265228
ISRCTN48265228未知未知

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

King's College London0 个研究点目标入组 50 人开始时间: 2016年12月31日最近更新:

试验速览

阶段
未知
入组人数
50

研究概览

简要总结

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

研究设计

研究类型
Interventional

入排标准

性别
Male

入选标准

  • 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

排除标准

  • 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

研究者

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