跳至主要内容
临床试验/ACTRN12623000757617
ACTRN12623000757617进行中(未招募)Unknown

A Randomised Waitlist Controlled Trial to Evaluate the Efficacy of Individual Alpha Frequency-guided Repetitive Transcranial Magnetic Stimulation for Sleep Difficulties in Children with Autism Spectrum Disorder.

chenna Ezedinma0 个研究点目标入组 20 人开始时间: 2023年7月11日最近更新:
适应症

试验速览

阶段
Unknown
状态
进行中(未招募)
发起方
入组人数
20

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Open (masking not used)

入排标准

年龄范围
6 Years 至 12 Years(—)
性别
All

入选标准

  • i.Children aged 6-12 years with a valid diagnosis of ASD (level 2) and SD, and their primary caregivers,
  • ii.Meet the definition of sleep difficulties based on the clinical cut-off of >41 on the Children's Sleep Habits Questionnaire (CSHQ).
  • iii.Children who can complete pre-assessment EEG and polysomnography (level 2 home sleep study).

排除标准

  • Co-diagnosis of congenital conditions such as Down syndrome.
  • ii. Child with a reported history of rTMS use.
  • iii. Child with diagnosed nocturnal seizures, blindness, and moderate-severe obstructive sleep apnoea (OSA).
  • iv. Child with body implants such as pacemaker, Defibrillator, Vagal Nerve Stimulator, VP Shunt/ Magnetic intracranial shunts, Deep Brain Stimulator, Epidural Cortical stimulator, Steel shunts/stents, Cranial metal fragments (i.e. shrapnel, excluding titanium), Cochlear implant, aneurysm clips, coils, pipelines flow diversion, magnetic dental implants, Implanted cardioverter defibrillators (ICD), and Ocular implants
  • v. Child that is still breast feeding.
  • vi. Child with primary brain cancer / metastatic legions in the brain (unless palliative care)

研究者

发起方
chenna Ezedinma

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