跳至主要内容
临床试验/NCT04936009
NCT04936009
招募中
不适用

Noninvasive Brain Stimulation to Treat Core Social Deficits in Autism Spectrum Disorder

Yale University1 个研究点 分布在 1 个国家目标入组 60 人2022年3月17日

概览

阶段
不适用
干预措施
Transcranial Magnetic Stimulation (TMS)
疾病 / 适应症
Autism Spectrum Disorder
发起方
Yale University
入组人数
60
试验地点
1
主要终点
right hemisphere N170 latency
状态
招募中
最后更新
2个月前

概览

简要总结

This is a randomized interventional study designed to evaluate the effects of repetitive Transcranial Magnetic Stimulation (rTMS) on neural and behavioral facets of social cognition in adults with autism spectrum disorder (ASD).

详细描述

The primary objective of this study is to determine whether rTMS increases the brain response to faces in a population of adults with ASD. This study will assess critical aspects of social cognition using the electroencephalogram (EEG), event-related potentials (ERPS), and eye-tracking (ET) prior to and following a single rTMS session (or Sham) to provide preliminary insight into the potential of rTMS as a tool to modify social brain function in this population. Participant visits will include a baseline assessment of neuropsychological, cognitive and behavioral function, and a pre and post TMS session with EEG (electroencephalogram) and eye-tracking to measure neural and visual attentional social response. Two study visits will be scheduled for each participant lasting approximately 4-5hrs total.

注册库
clinicaltrials.gov
开始日期
2022年3月17日
结束日期
2027年7月1日
最后更新
2个月前
研究类型
Interventional
研究设计
Crossover
性别
All

研究者

责任方
Sponsor

入排标准

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.
  • Individuals 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 excluded.
  • Participants with a history of prior TMS therapy or use of an investigational drug within 12 weeks of visit.
  • Participants with an IQ (intelligence quotient) below 80.

研究组 & 干预措施

Transcranial Magnetic Stimulation - real

Participants will receive active TMS during their study visit

干预措施: Transcranial Magnetic Stimulation (TMS)

Transcranial Magnetic Stimulation - sham

Participants will receive sham stimulation during their study visit simulating TMS

干预措施: Transcranial Magnetic Stimulation (TMS)

结局指标

主要结局

right hemisphere N170 latency

时间窗: Measures will be recorded during the EEG/ET sessions of participant visits for an expected 1-2 hours

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

proportion of visual attention to the eye region of the face

时间窗: Measures will be recorded during the EEG/ET sessions of participant visits for an expected 1-2 hours

visual attention to the eye region of the face as measured by eye tracking in seconds

研究点 (1)

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