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Modulation of the Activity of the Cerebellum in Autism (MACA)

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05781412
Acronym
MACA
Enrollment
100
Registered
2023-03-23
Start date
2022-05-24
Completion date
2024-10-30
Last updated
2023-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

Keywords

tDCS, Cerebellum, neuromodulation, autism

Brief summary

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.

Detailed description

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.

Interventions

DEVICEtDCS

Anodal and Sham cerebellar tDCS will be used in each participant in a counterbalanced order

Sponsors

Vrije Universiteit Brussel
CollaboratorOTHER
University Ghent
CollaboratorOTHER
Universitair Ziekenhuis Brussel
CollaboratorOTHER
Beatriz Catoira
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Intervention model description

There will be three groups of participants: autism-diagnosed, autism-non-diagnosed and neurotypical individuals (healthy controls). On each group, participants will be randomly allocated to one of two groups: anodal stimulation in the first session or anodal stimulation in the second session (in the other session there will be sham stimulation).

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

Participant Inclusion/

Exclusion criteria

* Participants must be more than 18 years old * normal eyesight and hearing; * Dutch, French or English speaking; Neurotypical participants inclusion/

Design outcomes

Primary

MeasureTime frameDescription
White matter integrity in the cerebellumassessment will begin immediately after stimulation and last up to 10 minutesWhite matter integrity matrix (FA, MD, RD) in the cerebellum using tract-based spatial statistics in the cerebellum & differences between groups
Brain activity at the pictorial sequencing taskassessment will begin 10 minutes after stimulation and last up to 15 minutesBrain 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...)
PS_RTassessment will begin 10 minutes after stimulation and last up to 15 minutesReaction Time in the pictorial sequencing time
PS_accuracyassessment will begin 10 minutes after stimulation and last up to 15 minutesAccuracy in the pictorial sequencing task
ER_RTassessment will begin 20 minutes after stimulation and last up to 5 minutesReaction Times in the emotion recognition task
ER_accuracyassessment will begin 20 minutes after stimulation and last up to 5 minutesAccuracy in the emotion recognition task
Brain activity at the emotion recognition taskassessment will begin 20 minutes after stimulation and last up to 5 minutesBrain 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 stateassesment will begin concurrent with stimulation and last up to 20 minutesBrain 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...)

Secondary

MeasureTime frameDescription
Whole brain structural network constructionassessment will begin immediately after stimulation and last up to 10 minutesStructural connectivity (DWI) within the whole brain using graph theory
Fiber tractography between the cerebellum and the default mode/ mentalizing networkassessment will begin immediately after stimulation and last up to 10 minutesFiber tractography (Diffusion weighted imaging) between the cerebellum and the default mode / mentalizing network, by extraction of white matter integrity parameters on each fiber tract
ROI-based structural connectivityassessment will begin immediately after stimulation and last up to 10 minutesStructural connectivity (DWI) between ROIs from the default mode/mentalizing network
Connectivity_PStaskassessment will begin 10 minutes after stimulation and last up to 15 minutesBrain connectivity (fMRI) analysis on the pictorial sequencing task
Connectivity_ERtaskassessment will begin 20 minutes after stimulation and last up to 5 minutesBrain connectivity (fMRI) analysis on the emotion recognition task
Connectivity_stimulationassesment will begin concurrent with stimulation and last up to 20 minutesBrain connectivity (fMRI) analysis during stimulation

Other

MeasureTime frameDescription
Correlations between DWI, behavioural data, simulation and functional dataassessment will include data from the 60 minutes that are spent in the scanner in the sessionThe primary outcome measures from the diffusion weighted imaging will provide different measures for structural connectivity per participant. The correlation of these measures with behavioural and/or functional data will be computed.
Electrical Field SimulationsFirst 10 minutes of assessmentSimulation of the electric field generated by the tDCS stimulation.

Countries

Belgium

Contacts

Primary ContactBeatriz Catoira, Msc
Beatriz.catoira@vub.be+32456267472
Backup ContactNathalie Vanderbruggen
Nathalie.Vanderbruggen@uzbrussel.be02/ 4763599

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026