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临床试验/NCT05396352
NCT05396352招募中不适用

Cerebellum and Autism: Regional Specialization for Social and Executive Functions

American University2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
80
试验地点
2
主要终点
Cyberball social ball-playing task

研究概览

简要总结

The goal of this study is to determine the impact of neuromodulation to the cerebellum on social and executive functions in neurotypical young adults and young adults with autism.

详细描述

Autism spectrum disorder is a prevalent neurodevelopmental condition characterized by deficits in social communication and the presence of repetitive and inflexible behaviors. There are currently few biologically-targeted treatment options for autism, in part because the underlying neurobiology is not well understood. One region of the brain that is consistently implicated in autism is the cerebellum. Specifically, two cerebellar subregions show structural and functional differences in autism: right cerebellar lobule VII (RVII) and the posterior cerebellar vermis. Based on the different anatomical connectivity of these regions, the investigators hypothesize that RVII and the posterior vermis regulate different core deficits in autism. In this study, the investigators combine cerebellar neuromodulation with functional neuroimaging to test the hypothesis that neuromodulation targeting RVII will selectively alter social learning and neural networks supporting social behavior, while neuromodulation targeting the posterior vermis will impact cognitive flexibility and neural networks involved in the allocation of attention. Neurotypical adults and adults with autism will complete social and cognitive flexibility tasks after excitatory, inhibitory, or sham neuromodulation in a within-subjects design. Some participants will receive neuromodulation targeting RVII and others will receive neuromodulation targeting the posterior vermis. The investigators will acquire functional brain imaging data during and after cerebellar neuromodulation, which will allow the team to better understand the mechanisms by which non-invasive neuromodulation might impact behavior in clinical disorders.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Please note: This study takes place at American University and Georgetown University in Washington, DC. We do not have funds for travel and lodging available for this study, so participants should be local to the DC region.
  • Inclusion Criteria:
  • All participants
  • Aged 18-35
  • Able to provide written, informed consent
  • NIH Toolbox age-adjusted Cognitive Function Composite standard score ≥ 85
  • Native English speaker
  • Right-handed
  • Not pregnant
  • Able to attend all study sessions
  • Pass safety screening for MRI and neuromodulation (e.g. no metal in body, implanted devices, history of seizure, claustrophobia)
  • Additional INCLUSION criteria for adults with autism Either
  • Prior research-reliable diagnosis of autism spectrum disorder (ASD) Or
  • Meet DSM-5 criteria for ASD confirmed with ADOS-2 via research-reliable clinical assessment

排除标准

  • Neurotypical adults
  • Age <18 or >35
  • NIH Toolbox age-adjusted Cognitive Function Composite standard score < 85
  • Contraindications for MRI or neuromodulation with tDCS (e.g. metal in body, pacemaker or other implanted device, history of seizure, claustrophobia)
  • Current or prior history of neurological or neurodevelopmental condition or brain injury
  • Psychotropic medication
  • Pregnancy
  • Adults with autism
  • Age <18 or >35
  • Participants with a legal authorized representative
  • NIH Toolbox age-adjusted Cognitive Function Composite standard score < 85
  • Contraindications for MRI or neuromodulation with tDCS (e.g. metal in body, pacemaker or other implanted device, history of seizure, claustrophobia)
  • Pregnancy

结局指标

主要结局

Cyberball social ball-playing task

时间窗: Within 30min post-tDCS

Functional MRI data

时间窗: Within 45min post-tDCS

Functional MRI task data and resting state functional connectivity data

Reading the Mind in the Eyes Test Adult Version

时间窗: Within 30min post-tDCS

Flexible Item Selection Test

时间窗: Within 30min post-tDCS

次要结局

未报告次要终点

研究者

发起方
American University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Catherine Stoodley

Associate Professor

American University

研究点 (2)

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