跳至主要内容
临床试验/NCT05781412
NCT05781412招募中不适用

Modulation of the Activity in the Cerebellum With Transcranial Direct Current Stimulation in Autistic Participants

Beatriz Catoira1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年5月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
PS_RT

研究概览

简要总结

Research on the involvement of the cerebellum in social understanding behavior and the mentalizing brain system has just begun. Knowledge about the neurobiology of social understanding is important for understanding the ways to manipulate these processes. Like cerebral tDCS, cerebellar tDCS could then be used to enhance more complex processes, such as mentalizing, in healthy individuals. It can eventually also be examined as a therapeutic tool for patients with mentalizing difficulties such as patients with ASD. In this study, it is examined whether anodal tDCS at the right posterior cerebellum influences social understanding and which cerebro-cerebellar networks play a role in this process.

详细描述

Autism Spectrum Disorders (ASD) are a group of lifelong neurodevelopmental disorders characterized by social and communicative difficulties and repetitive and stereotyped behaviors. Research has shown that cerebellar abnormalities are among the most important etiological factors for ASD. The cerebellum is found to be most frequently involved in tasks where participants must remember or imagine past or future autobiographical events, judge persons or situations based on behavioral sentences, make trait inferences of others using stories, words or faces, and describe persons or objects based on behavioral or object pictures. Recent research has also provided evidence on the involvement of the posterior areas of the cerebellum in social cognition.

Specifically, the areas crus I and crus II, located at the lateral hemispheres of the posterior cerebellum, are associated with more complex cognitive and social processes, such as mentalizing. Mentalizing is the cognitive ability to attribute mental states, such as desires, intentions, and beliefs, to other people. This ability is needed to understand and predict other people's behavior and is the main component of social cognition. Problems with mentalizing, including the attribution of false beliefs to others, are characteristic for autism spectrum disorder (ASD). A sequencing task (that included social and non social conditions) showing that cerebellar patients performed worse than healthy participants.

Facial emotion recognition refers to the ability to derive emotional meaning from facial expressions and has been shown to underlie social competency. Recent literature reviews have reported significant facial emotion recognition impairments in individuals with ASD. These impairments take various forms, such as a reduced accuracy in labeling facial emotions or reduced specificity in rating facial emotions of varying intensity . Thus, there is evidence suggesting that ASD is associated with a selective impairment in facial emotion recognition.

Transcranial direct current stimulation (tDCS) is a noninvasive technique that can produce long-lasting changes in the excitability and spontaneous activity of the stimulated brain areas. Therefore, tDCS is investigated as a possible treatment for different psychiatric diseases. Cerebellar tDCS have shown to also produce prolonged changes successfully at the neural and behavioral level. However, due to the high density of neurons in the cerebellum and diffuse connections to the cerebrum, it is more difficult to understand the working mechanisms of cerebellar as compared to cerebral tDCS. In addition, the electrical current will spread across more neurons in the cerebellum by cerebellar tDCS and will functionally affect the cerebral regions to which these cerebellar neurons are connected as well. Therefore, the type of behavioral effect, such as an improvement of performance after anodal tDCS or an impairment of performance after cathodal tDCS, is harder to predict for cerebellar than cerebral tDCS.

Modulation of social understanding with tDCS has been studied by stimulating the key mentalizing regions mPFC and TPJ. In healthy participants, an improvement on tasks was found that required the enhancement or inhibition of representation of the self or of others, which is important for mentalizing, after anodal tDCS at the TPJ compared to sham tDCS or cathodal tDCS. The effect of cerebellar tDCS on social understanding using action sequences has not yet been examined.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Participant Inclusion/

排除标准

  • •Participants must be more than 18 years old
  • •normal eyesight and hearing;
  • •Dutch, French or English speaking;
  • •Neurotypical participants inclusion/exclusion criteria:
  • •No disorder (now or in the past) that could have affected the brain such as cerebrovascular accidents (CVA), neurodegenerative disorders, or essential tremor;
  • •No neurological diseases that could affect reasoning or intellectual abilities (such as Parkinson's Disease, Epilepsy, and Multiple Sclerosis)
  • •Neurotypical participants will be matched on age and gender to the ASD population;
  • •ASD participants inclusion/exclusion criteria:
  • •Patients with a formal diagnosis of high-functioning ASD as determined by the clinical psychologist/psychiatrist.

研究组 & 干预措施

ASD_anodalstimulation

Active Comparator

ASD participant, anodal stimulation on the first session, sham stimulation on the second sesion

干预措施: tDCS (Device)

ASD_shamstimulation

Sham Comparator

ASD participant, sham stimulation on the first session, anodal stimulation on the second sesion

干预措施: tDCS (Device)

NT_anodalstimulation

Active Comparator

Neurotypical participant, anodal stimulation on the first session, sham stimulation on the second sesion

干预措施: tDCS (Device)

NT_shamstimulation

Sham Comparator

Neurotypical participant, sham stimulation on the first session, anodal stimulation on the second sesion

干预措施: tDCS (Device)

H-AQ_anodalstimulation

Active Comparator

non diagnosed autistic participant,anodal stimulation on the first session, sham stimulation on the second sesion

干预措施: tDCS (Device)

H-AQ_shamstimulation

Sham Comparator

non diagnosed autistic participant, sham stimulation on the first session, anodal stimulation on the second sesion

干预措施: tDCS (Device)

结局指标

主要结局

PS_RT

时间窗: assessment will begin 10 minutes after stimulation and last up to 15 minutes

Reaction Time in the pictorial sequencing time

PS_accuracy

时间窗: assessment will begin 10 minutes after stimulation and last up to 15 minutes

Accuracy in the pictorial sequencing task

ER_accuracy

时间窗: assessment will begin 20 minutes after stimulation and last up to 5 minutes

Accuracy in the emotion recognition task

Brain activity at the emotion recognition task

时间窗: assessment will begin 20 minutes after stimulation and last up to 5 minutes

Brain activity (fMRI) in regions of interest/whole brain analysis. Differences between stimulation and sham, between task conditions and between sessions as well as possible interactions in between those factors and covariates (AQ scores, age, gender...)

Brain activity at resting state

时间窗: assesment will begin concurrent with stimulation and last up to 20 minutes

Brain activity (fMRI) in regions of interest/whole brain analysis. Differences between stimulation and sham, between task conditions and between sessions as well as possible interactions in between those factors and covariates (AQ scores, age, gender...)

Brain activity at the pictorial sequencing task

时间窗: assessment will begin 10 minutes after stimulation and last up to 15 minutes

Brain activity (fMRI) in regions of interest/whole brain analysis. Differences between stimulation and sham, between task conditions and between sessions as well as possible interactions in between those factors and covariates (AQ scores, age, gender...)

White matter integrity in the cerebellum

时间窗: assessment will begin immediately after stimulation and last up to 10 minutes

White matter integrity matrix (FA, MD, RD) in the cerebellum using tract-based spatial statistics in the cerebellum \& differences between groups

ER_RT

时间窗: assessment will begin 20 minutes after stimulation and last up to 5 minutes

Reaction Times in the emotion recognition task

次要结局

  • Connectivity_PStask(assessment will begin 10 minutes after stimulation and last up to 15 minutes)
  • Connectivity_ERtask(assessment will begin 20 minutes after stimulation and last up to 5 minutes)
  • Connectivity_stimulation(assesment will begin concurrent with stimulation and last up to 20 minutes)
  • Fiber tractography between the cerebellum and the default mode/ mentalizing network(assessment will begin immediately after stimulation and last up to 10 minutes)
  • ROI-based structural connectivity(assessment will begin immediately after stimulation and last up to 10 minutes)
  • Whole brain structural network construction(assessment will begin immediately after stimulation and last up to 10 minutes)

研究者

发起方
Beatriz Catoira
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Beatriz Catoira

MsC, PhD student at the Vrije Universiteit Brussel

Vrije Universiteit Brussel

研究点 (1)

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