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临床试验/NCT04242355
NCT04242355进行中(未招募)不适用

Effects of Repetitive Transcranial Magnetic Stimulation on Neural and Behavioral Facets of Social Cognition in Autism Spectrum Disorder

Yale University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
100
试验地点
1
主要终点
right lateralized N170 latency to upright faces

研究概览

简要总结

This study will evaluate the effects of repetitive Transcranial Magnetic Stimulation (rTMS) on neural and behavioral facets of social cognition in Autism Spectrum Disorder (ASD). Participant visits will include a baseline assessment of neuropsychological, cognitive and behavioral function, and an EEG (electroencephalogram) and eye-tracking session to measure neural and visual attentional social response before and after administration of TMS.

详细描述

Broad ranging social cognition difficulties are hallmark areas of impairment in autism spectrum disorder (ASD), and they are subserved by specific neural systems underpinning social perception and processing that are recognized to be atypical in ASD. Considering the neurodevelopmental nature of the disorder, and the recent findings regarding aberrant neuroplasticity in ASD, repetitive transcranial magnetic stimulation (rTMS) holds promise to directly modulate brain activity in these systems. The objective of this research proposal is to utilize a multimodal approach to provide a proof-of-concept for the ability of rTMS to (a) influence functioning in the brain systems involved in social ASD symptomatology and (b) modify associated social cognitive behaviors in adults with ASD. Toward achieving this objective, we propose to assess critical aspects of social cognition using the electroencephalogram (EEG), event-related potentials (ERPS), eye-tracking (ET), and behavioral tasks prior to and following a single rTMS session to provide preliminary insight into the potential of rTMS as a tool to modify social brain function in cognitively able adults with ASD.

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
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • individuals between the ages of 18 and 40 years old with typical development or with a diagnosis of autism spectrum disorder.
  • able to participate in an EEG and eye-tracking experiment

排除标准

  • Participants reporting significant head trauma or serious brain illness
  • Participants with major psychiatric illness that would preclude completion of study measures.
  • Participants with a history of serious medical illness, stroke, seizures, epileptiform EEG abnormalities, or family history of seizures.
  • Participants taking prescription medications that may affect cognitive processes under study.
  • Participants who have taken alcohol or recreational drugs within the preceding 24 hours.
  • Females of known/suspected pregnancy or who test positive on a pregnancy test.
  • Participants with a history of metalworking or injury by shrapnel or metallic objects are also exclude

研究组 & 干预措施

Transcranial Magnetic Stimulation - real

Active Comparator

Participants will receive active TMS during their study visit

干预措施: Transcranial Magnetic Stimulation (TMS) (Behavioral)

Transcranial Magnetic Stimulation - sham

Placebo Comparator

Participants will receive sham stimulation during their study visit simulating TMS

干预措施: Transcranial Magnetic Stimulation (TMS) (Behavioral)

结局指标

主要结局

right lateralized N170 latency to upright faces

时间窗: Measures will be recorded for the duration of their visit, an expected average of 4-5 hrs.

EEG brain response to faces as measured by the N170 component in milliseconds

次要结局

  • proportion of visual attention to the eye region of the face(Measures will be recorded for the duration of their visit, an expected average of 4-5 hrs.)
  • The Benton Face Recognition Task(Measures will be recorded for the duration of their visit, an expected average of 4-5hrs)

研究者

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

James C. McPartland

Associate Professor of Child Psychiatry and Psychology

Yale University

研究点 (1)

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