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
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