DRKS00014732已完成2 期
Phase-IIa randomized, double-blind, sham-controlled, parallel group trial on anodal tDCS over the left and right tempo-parietal junction in Autism Spectrum Disorder - StimAT
Goethe University Frankfurt0 个研究点目标入组 24 人开始时间: 2018年8月15日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
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
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 10 Years 至 17 Years（—）
- 性别
- All
入选标准
- •Expert clinical ASD diagnosis according to DSM-5 supported by ADI-R and ADOS, including all Autism Spectrum Disorders (299.00)
- •Age = 10 to <18 years old at randomization
- •participant and their parents are able and willing to give written informed assent/consent
排除标准
- •Birth weight < 2000 grams
- •Cerebral palsy, tuberous sclerosis, neurofibromatosis
- •History of brain surgery, cochlear implant, skull deformity,
- •History of craniocerebral injury with loss of consciousness
- •Increased intracranial pressure
- •History of epilepsy or seizures or migraine in patients or first-degree relatives
- •Current vision (less than 80% of normal vision in both eyes) or hearing impairments (failure to correctly locate the direction of which a sound is coming from; this is determined using Weber and Rinne tuning forks)
- •Any comorbid mental disorders other than the following (classified according to DSM-5):
- •o All Communication Disorders
- •o Attention Deficit Hyperactivity Disorder (ADHD)
- •o Specific learning disorder with IQ>=70
- •o Developmental coordination disorder
- •o Major Depressive Disorder: Mild Depressive Episode
- •o Dysthymia
- •o All Anxiety Disorders
- •o All Elimination Disorders
- •o Gender Dysphoria
- •o Oppositional Defiant Disorder
- •o ASD-related sleeping problems
- •o ASD-related eating problems
- •Dermatological disease of the scalp or chronic skin damage
- •Any electrically, mechanically or magnetically activated implant (for example, brain implant, pacemakers, cardiac implants, vascular clips)
- •Heart disease
- •Current pregnancy or hormonal contraception
- •History of smoking within last five years
- •Concurrent psychopharmacological treatment that has an influence on the central nervous system
- •Concurrent neurofeedback or stimulation therapy
- •Participation in other clinical trials
研究者
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