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临床试验/NCT00808782
NCT00808782已完成不适用

The Use of rTMS to Improve Theory of Mind Among Adults With Autism and Asperger's Disorder

Bayside Health2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2008年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Theory of Mind Neurobehavioural Battery

研究概览

简要总结

Theory of mind (ToM) refers to the ability to infer others mental states. It includes a recognition that other individuals experience thoughts, feelings, intentions, and desires that may be different to our own. ToM is often impaired among individuals with an autism spectrum disorder (such as autism and Asperger's disorder), and may underlie aspects of social dysfunction in this population. Indeed, it has been suggested that impaired ToM is the core deficit of autism and Asperger's disorder.

Imaging studies suggest that the bilateral medial prefrontal cortex, the most important brain region in ToM processing, is underactive in autism. The current study examines whether repetitive transcranial magnetic stimulation (rTMS) to the bilateral medial prefrontal cortex can modulate ToM ability among healthy adults, and improve ToM ability among adults with autism or Asperger's disorder. With the prevalence of autism increasing, there is a clear need to develop appropriate therapeutic interventions to improve social functioning.

This study involves a double-blind study using high-frequency rTMS in an attempt to improve ToM among adults with either autism or Asperger's disorder. Theory of mind will be measured using behavioural tasks that require the participant to infer what someone is thinking or feeling by observing their behaviour. These tasks will administered both before and after rTMS to determine whether any change in theory of mind has occurred.

Thirty adults with either autism (n = 15) or Asperger's disorder (n = 15) will initially undergo functional and structural MRI to determine the site on the scalp that lies over the medial prefrontal cortex (to which rTMS will be administered). They will then attend our lab each consecutive weekday for a two-week period, during which they will 15 minutes high-frequency (5 Hz) rTMS (either active or sham) to the medial prefrontal cortex. ToM and clinical measures will be collected before the first session, soon after the last session, and one month after the last session.

Based on prior imaging data, it is expected that high-frequency rTMS (compared with sham rTMS) to the medial prefrontal cortex will improve ToM ability and reduce social dysfunction among adults with autism or Asperger's disorder. Should these hypotheses be supported, it will indicate the suitability of rTMS as a neurobiological intervention designed to improve ToM and social function among individuals with autism and related disorders.

详细描述

Autism and Asperger's disorder are life-long neurodevelopmental disorders that involve significant social, communicative, and behavioural abnormalities. Social impairments are arguably the most debilitating aspect of these disorders, and persist into adulthood, creating difficulties in various domains including employment, education, and interpersonal relationships. This impairment is also frequently associated with additional mental health concerns, including depression and anxiety, with the former affecting as many as 40% of individuals with autism (Stewart, Barnard, Pearson, Hasan, & O'Brien, 2006). It has been suggested that the core deficit underlying social dysfunction in autism and Asperger's disorder is impairment in "theory of mind" (ToM) (Baron- Cohen et al., 2005).

An important aspect of social cognition, ToM refers to the ability to use environmental cues to infer others' mental states. It includes the recognition that other individuals experience thoughts, feelings, intentions, and desires that may be different to our own. ToM is crucial to social functioning, allowing us to predict others behaviour and gain an appreciation of their perspective, thereby facilitating effective social interactions.

ToM has been assessed using an array of behavioural tasks. Such tasks typically illustrate a social scenario, and the aim of the task is to identify various aspects of a character's mental state. Increasingly, researchers distinguish between cognitive ToM, which encompasses inferences of another individual's beliefs, knowledge or memory, and affective ToM, which is concerned with predicting others' emotional states (Shamay-Tsoory & Aharon-Peretz, 2007).

Cognitive ToM measures include false-belief tasks, successful completion of which requires an understanding that another individual can hold a mistaken belief (first-order false-belief), and that are therefore different to their own belief, or that another individual can hold a mistaken belief about the mental state of a third person (second-order false-belief; Harrington, Siegert, & McClure, 2005). Another cognitive ToM task involves inferring intention from a series of short animations that demonstrate interactions between non-human objects (e.g., geometric shapes; Castelli, Frith, Happe, & Frith, 2002).

By contrast, affective ToM measures include the "eyes task" (Baron- Cohen, Wheelwright, Hill, Raste, & Plumb, 2001), which requires the inference of another individual's emotional experience through the presentation of their eyes only. The eyes task is considered a ToM measure in that it involves the inference of another individual's mental state from environmental stimuli, but unlike false-belief tasks there is a central affective component.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

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

入选标准

  • 18 years or above. DSM-IV-TR diagnosis of either autistic disorder (autism) or Asperger's disorder.

排除标准

  • Hearing or visual impairment. Neurological illness (e.g., epilepsy).
  • Unstable medical condition.
  • History of seizures or convulsions.
  • History of serious head injury. Metal implants or medical devices (e.g., pacemaker, cochlear implant, medication pump) in the head or body. Professional drivers.
  • Machine operators.
  • Women who are pregnant or lactating.

结局指标

主要结局

Theory of Mind Neurobehavioural Battery

时间窗: Pre, Post, One-month Post

次要结局

  • Autism Spectrum Quotient(Pre, Post, One-month Post)

研究者

发起方
Bayside Health
申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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