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临床试验/NCT02836405
NCT02836405已完成不适用

Investigations of Neuroplasticity Mechanisms in Autism Spectrum Disorders

Boston Children's Hospital2 个研究点 分布在 1 个国家目标入组 164 人开始时间: 2015年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
164
试验地点
2
主要终点
Percent of baseline TMS-induced measures of human synaptic plasticity

研究概览

简要总结

The main purpose is to study brain plasticity (the changes that occur in the brain through experience) in individuals with autism spectrum disorder (ASD). Research suggests that during development, the brains of individuals with ASD may change in response to their experiences differently than the brains of typically developing individuals. Investigators want to understand why and how this difference may contribute to the symptoms of ASD.

详细描述

Autism Spectrum Disorders (ASD) are diagnosed clinically, based on key symptoms. As ASD phenotypic variability is large, and symptoms can manifest at different ages and degrees, the clinical diagnosis is challenging. To date, there remains an unmet need for a valid and reliable endophenotype that would facilitate ASD diagnosis early in life, enable efficient study of ASD risk factors, and eventually serve as a useful biomarker to inform the development of effective therapies and assess treatment response in future clinical trials.

As compared with behavioral or neuroimaging methods, transcranial magnetic stimulation (TMS) offers the advantage of providing behaviorally independent results that are largely unaffected by attention or cognitive ability. Therefore, a TMS based endophenotype may be applicable to all individuals across the autism spectrum.

At Boston Children's Hospital, each subject's participation in the study will consist of four visits: two screening visits, and two TMS sessions. At Beth Israel Deaconess Medical Center, each subject's participation will consist of three visits: one screening visit, and two TMS sessions. Each screening visit is expected to last between 2-3 hours, during which participants will first provide informed consent. Participants will then receive a thorough medical examination by a neurologist, and a neuropsychological evaluation (including IQ measures and ASD specific evaluations). If eligible to continue, participants will then come back for two identical TMS visits, that are spaced 1-5 weeks apart. These visits are expected to last between 3-4 hours, and include the TMS measures of brain plasticity.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
6 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Intracranial pathology, cerebral palsy, history of severe head injury, significant dysmorphology, or known intracranial lesion.
  • History of fainting spells of unknown or undetermined etiology.
  • History of head injury resulting in prolonged loss of consciousness.
  • History of seizures, diagnosis of epilepsy, or immediate family history of epilepsy.
  • Any progressive neurological disorder or signs of intracranial pressure.
  • Chronic uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure.
  • Metal implants or devices.
  • Substance abuse or dependence within the past six months.
  • Certain prescription medications that decrease cortical seizure threshold.
  • Pregnancy.

结局指标

主要结局

Percent of baseline TMS-induced measures of human synaptic plasticity

时间窗: 120 minutes after cTBS

Synaptic plasticity will be measured using the MEPs in response to cTBS. Baseline MEPs will be calculated before cTBS, and at different time points following cTBS up to 120 minutes. The investigators will compare post-cTBS MEPs to the baseline MEPs to calculate the percent change from baseline.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alexander Rotenberg

Associate Professor of Neurology

Boston Children's Hospital

研究点 (2)

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