Autism Spectrum DisorderMACANCT05781412
Modulation of the Activity of the Cerebellum in Autism (MACA)
A study testing tDCS in people with Autism Spectrum Disorder, run by Beatriz Catoira at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 24 May 2022to 30 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Participant Inclusion/exclusion criteria:
- 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.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
UZ Brussel
Jette, Brussels Capital, 1090
Beatriz Catoira, 0456267472 ext. 0032, beatriz.catoira@vub.be
About this study
Official title: Modulation of the Activity in the Cerebellum With Transcranial Direct Current Stimulation in Autistic Participants
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.
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- tDCS
- Keywords
- tDCS, Cerebellum, neuromodulation, autism
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
Anodal and Sham cerebellar tDCS will be used in each participant in a counterbalanced order
| Study group | Role | What they receive |
|---|---|---|
| ASD_anodalstimulation | Active comparator | ASD participant, anodal stimulation on the first session, sham stimulation on the second sesion Receives: Device: tDCS |
| ASD_shamstimulation | Sham comparator | ASD participant, sham stimulation on the first session, anodal stimulation on the second sesion Receives: Device: tDCS |
| NT_anodalstimulation | Active comparator | Neurotypical participant, anodal stimulation on the first session, sham stimulation on the second sesion Receives: Device: tDCS |
| NT_shamstimulation | Sham comparator | Neurotypical participant, sham stimulation on the first session, anodal stimulation on the second sesion Receives: Device: tDCS |
| H-AQ_anodalstimulation | Active comparator | non diagnosed autistic participant,anodal stimulation on the first session, sham stimulation on the second sesion Receives: Device: tDCS |
| H-AQ_shamstimulation | Sham comparator | non diagnosed autistic participant, sham stimulation on the first session, anodal stimulation on the second sesion Receives: Device: tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
PS_RT
Reaction Time in the pictorial sequencing time
Measured: assessment will begin 10 minutes after stimulation and last up to 15 minutes
PS_accuracy
Accuracy in the pictorial sequencing task
Measured: assessment will begin 10 minutes after stimulation and last up to 15 minutes
ER_RT
Reaction Times in the emotion recognition task
Measured: assessment will begin 20 minutes after stimulation and last up to 5 minutes
ER_accuracy
Accuracy in the emotion recognition task
Measured: assessment will begin 20 minutes after stimulation and last up to 5 minutes
Brain activity at the emotion recognition task
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...)
Measured: assessment will begin 20 minutes after stimulation and last up to 5 minutes
Brain activity at resting state
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...)
Measured: assesment will begin concurrent with stimulation and last up to 20 minutes
Brain activity at the pictorial sequencing task
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...)
Measured: assessment will begin 10 minutes after stimulation and last up to 15 minutes
White matter integrity in the cerebellum
White matter integrity matrix (FA, MD, RD) in the cerebellum using tract-based spatial statistics in the cerebellum \& differences between groups
Measured: assessment will begin immediately after stimulation and last up to 10 minutes
Secondary outcomes (6)
Connectivity_PStask
Brain connectivity (fMRI) analysis on the pictorial sequencing task
Measured: assessment will begin 10 minutes after stimulation and last up to 15 minutes
Connectivity_ERtask
Brain connectivity (fMRI) analysis on the emotion recognition task
Measured: assessment will begin 20 minutes after stimulation and last up to 5 minutes
Connectivity_stimulation
Brain connectivity (fMRI) analysis during stimulation
Measured: assesment will begin concurrent with stimulation and last up to 20 minutes
Fiber tractography between the cerebellum and the default mode/ mentalizing network
Fiber tractography (Diffusion weighted imaging) between the cerebellum and the default mode / mentalizing network, by extraction of white matter integrity parameters on each fiber tract
Measured: assessment will begin immediately after stimulation and last up to 10 minutes
ROI-based structural connectivity
Structural connectivity (DWI) between ROIs from the default mode/mentalizing network
Measured: assessment will begin immediately after stimulation and last up to 10 minutes
Whole brain structural network construction
Structural connectivity (DWI) within the whole brain using graph theory
Measured: assessment will begin immediately after stimulation and last up to 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start24 May 2022
- Primary completion1 Mar 2024 (estimated)
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beatriz Catoira
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Beatriz Catoira, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05781412
- Sponsor's protocol ID
- 22064MACA
- Acronym
- MACA
- Status last verified
- Apr 2023
- First submitted
- 6 Dec 2022
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Van Overwalle F, Baetens K, Marien P, Vandekerckhove M. Social cognition and the cerebellum: a meta-analysis of over 350 fMRI studies. Neuroimage. 2014 Feb 1;86:554-72. doi: 10.1016/j.neuroimage.2013.09.033. Epub 2013 Sep 27.
PubMed 24076206Buckner RL, Krienen FM, Castellanos A, Diaz JC, Yeo BT. The organization of the human cerebellum estimated by intrinsic functional connectivity. J Neurophysiol. 2011 Nov;106(5):2322-45. doi: 10.1152/jn.00339.2011. Epub 2011 Jul 27.
PubMed 21795627Murphy CM, Wilson CE, Robertson DM, Ecker C, Daly EM, Hammond N, Galanopoulos A, Dud I, Murphy DG, McAlonan GM. Autism spectrum disorder in adults: diagnosis, management, and health services development. Neuropsychiatr Dis Treat. 2016 Jul 7;12:1669-86. doi: 10.2147/NDT.S65455. eCollection 2016.
PubMed 27462160Murphy DG, Beecham J, Craig M, Ecker C. Autism in adults. New biologicial findings and their translational implications to the cost of clinical services. Brain Res. 2011 Mar 22;1380:22-33. doi: 10.1016/j.brainres.2010.10.042. Epub 2010 Oct 20.
PubMed 20969835D'Mello AM, Stoodley CJ. Cerebro-cerebellar circuits in autism spectrum disorder. Front Neurosci. 2015 Nov 5;9:408. doi: 10.3389/fnins.2015.00408. eCollection 2015.
PubMed 26594140Fatemi SH, Aldinger KA, Ashwood P, Bauman ML, Blaha CD, Blatt GJ, Chauhan A, Chauhan V, Dager SR, Dickson PE, Estes AM, Goldowitz D, Heck DH, Kemper TL, King BH, Martin LA, Millen KJ, Mittleman G, Mosconi MW, Persico AM, Sweeney JA, Webb SJ, Welsh JP. Consensus paper: pathological role of the cerebellum in autism. Cerebellum. 2012 Sep;11(3):777-807. doi: 10.1007/s12311-012-0355-9.
PubMed 22370873Sathyanesan A, Zhou J, Scafidi J, Heck DH, Sillitoe RV, Gallo V. Emerging connections between cerebellar development, behaviour and complex brain disorders. Nat Rev Neurosci. 2019 May;20(5):298-313. doi: 10.1038/s41583-019-0152-2.
PubMed 30923348Heleven E, van Dun K, Van Overwalle F. The posterior Cerebellum is involved in constructing Social Action Sequences: An fMRI Study. Sci Rep. 2019 Jul 31;9(1):11110. doi: 10.1038/s41598-019-46962-7.
PubMed 31366954Van Overwalle F, Van de Steen F, Marien P. Dynamic causal modeling of the effective connectivity between the cerebrum and cerebellum in social mentalizing across five studies. Cogn Affect Behav Neurosci. 2019 Feb;19(1):211-223. doi: 10.3758/s13415-018-00659-y.
PubMed 30361864Leggio M, Olivito G. Topography of the cerebellum in relation to social brain regions and emotions. Handb Clin Neurol. 2018;154:71-84. doi: 10.1016/B978-0-444-63956-1.00005-9.
PubMed 29903453Frith CD, Frith U. Interacting minds--a biological basis. Science. 1999 Nov 26;286(5445):1692-5. doi: 10.1126/science.286.5445.1692.
PubMed 10576727Mier D, Lis S, Neuthe K, Sauer C, Esslinger C, Gallhofer B, Kirsch P. The involvement of emotion recognition in affective theory of mind. Psychophysiology. 2010 Nov;47(6):1028-39. doi: 10.1111/j.1469-8986.2010.01031.x.
PubMed 20456660Baron-Cohen S, Leslie AM, Frith U. Does the autistic child have a "theory of mind"? Cognition. 1985 Oct;21(1):37-46. doi: 10.1016/0010-0277(85)90022-8. No abstract available.
PubMed 2934210Leggio MG, Tedesco AM, Chiricozzi FR, Clausi S, Orsini A, Molinari M. Cognitive sequencing impairment in patients with focal or atrophic cerebellar damage. Brain. 2008 May;131(Pt 5):1332-43. doi: 10.1093/brain/awn040. Epub 2008 Mar 11.
PubMed 18334535Izard C, Fine S, Schultz D, Mostow A, Ackerman B, Youngstrom E. Emotion knowledge as a predictor of social behavior and academic competence in children at risk. Psychol Sci. 2001 Jan;12(1):18-23. doi: 10.1111/1467-9280.00304.
PubMed 11294223
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of the Activity in the Cerebellum With Transcranial Direct Current Stimulation in Autistic Participants
- ClinicalTrials.gov ID
- NCT05781412
- Acronym / sponsor ID
- MACA / 22064MACA
- Conditions
- Autism Spectrum Disorder
- Keywords
- tDCS, Cerebellum, neuromodulation, autism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Beatriz CatoiraUniversity, hospital or other
- Collaborators
- Vrije Universiteit Brussel, University Ghent, Universitair Ziekenhuis Brussel
- Study start
- 24 May 2022 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 23 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
- 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).
| Arm | Type | Receives |
|---|---|---|
| ASD_anodalstimulation | Active comparator | Device: tDCSASD participant, anodal stimulation on the first session, sham stimulation on the second sesion |
| ASD_shamstimulation | Sham comparator | Device: tDCSASD participant, sham stimulation on the first session, anodal stimulation on the second sesion |
| NT_anodalstimulation | Active comparator | Device: tDCSNeurotypical participant, anodal stimulation on the first session, sham stimulation on the second sesion |
| NT_shamstimulation | Sham comparator | Device: tDCSNeurotypical participant, sham stimulation on the first session, anodal stimulation on the second sesion |
| H-AQ_anodalstimulation | Active comparator | Device: tDCSnon diagnosed autistic participant,anodal stimulation on the first session, sham stimulation on the second sesion |
| H-AQ_shamstimulation | Sham comparator | Device: tDCSnon diagnosed autistic participant, sham stimulation on the first session, anodal stimulation on the second sesion |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCSAnodal and Sham cerebellar tDCS will be used in each participant in a counterbalanced order | Device | ASD_anodalstimulation, ASD_shamstimulation, H-AQ_anodalstimulation, H-AQ_shamstimulation, NT_anodalstimulation, NT_shamstimulation |
Primary outcome
PS_RT
Time frame: assessment will begin 10 minutes after stimulation and last up to 15 minutes
Reaction Time in the pictorial sequencing time
PS_accuracy
Time frame: assessment will begin 10 minutes after stimulation and last up to 15 minutes
Accuracy in the pictorial sequencing task
ER_RT
Time frame: assessment will begin 20 minutes after stimulation and last up to 5 minutes
Reaction Times in the emotion recognition task
ER_accuracy
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
6 secondary outcomes
Connectivity_PStask
Time frame: assessment will begin 10 minutes after stimulation and last up to 15 minutes
Connectivity_ERtask
Time frame: assessment will begin 20 minutes after stimulation and last up to 5 minutes
Connectivity_stimulation
Time frame: assesment will begin concurrent with stimulation and last up to 20 minutes
Fiber tractography between the cerebellum and the default mode/ mentalizing network
Time frame: assessment will begin immediately after stimulation and last up to 10 minutes
ROI-based structural connectivity
Time frame: assessment will begin immediately after stimulation and last up to 10 minutes
Whole brain structural network construction
Time frame: assessment will begin immediately after stimulation and last up to 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Results publication: PubMed 24076206Van Overwalle F, Baetens K, Marien P, Vandekerckhove M. Social cognition and the cerebellum: a meta-analysis of over 350 fMRI studies. Neuroimage. 2014 Feb 1;86:554-72. doi: 10.1016/j.neuroimage.2013.09.033. Epub 2013 Sep 27.
- Results publication: PubMed 21795627Buckner RL, Krienen FM, Castellanos A, Diaz JC, Yeo BT. The organization of the human cerebellum estimated by intrinsic functional connectivity. J Neurophysiol. 2011 Nov;106(5):2322-45. doi: 10.1152/jn.00339.2011. Epub 2011 Jul 27.
- Results publication: PubMed 27462160Murphy CM, Wilson CE, Robertson DM, Ecker C, Daly EM, Hammond N, Galanopoulos A, Dud I, Murphy DG, McAlonan GM. Autism spectrum disorder in adults: diagnosis, management, and health services development. Neuropsychiatr Dis Treat. 2016 Jul 7;12:1669-86. doi: 10.2147/NDT.S65455. eCollection 2016.
- Results publication: PubMed 20969835Murphy DG, Beecham J, Craig M, Ecker C. Autism in adults. New biologicial findings and their translational implications to the cost of clinical services. Brain Res. 2011 Mar 22;1380:22-33. doi: 10.1016/j.brainres.2010.10.042. Epub 2010 Oct 20.
- Results publication: PubMed 26594140D'Mello AM, Stoodley CJ. Cerebro-cerebellar circuits in autism spectrum disorder. Front Neurosci. 2015 Nov 5;9:408. doi: 10.3389/fnins.2015.00408. eCollection 2015.
- Results publication: PubMed 22370873Fatemi SH, Aldinger KA, Ashwood P, Bauman ML, Blaha CD, Blatt GJ, Chauhan A, Chauhan V, Dager SR, Dickson PE, Estes AM, Goldowitz D, Heck DH, Kemper TL, King BH, Martin LA, Millen KJ, Mittleman G, Mosconi MW, Persico AM, Sweeney JA, Webb SJ, Welsh JP. Consensus paper: pathological role of the cerebellum in autism. Cerebellum. 2012 Sep;11(3):777-807. doi: 10.1007/s12311-012-0355-9.
- Results publication: PubMed 30923348Sathyanesan A, Zhou J, Scafidi J, Heck DH, Sillitoe RV, Gallo V. Emerging connections between cerebellar development, behaviour and complex brain disorders. Nat Rev Neurosci. 2019 May;20(5):298-313. doi: 10.1038/s41583-019-0152-2.
- Results publication: PubMed 31366954Heleven E, van Dun K, Van Overwalle F. The posterior Cerebellum is involved in constructing Social Action Sequences: An fMRI Study. Sci Rep. 2019 Jul 31;9(1):11110. doi: 10.1038/s41598-019-46962-7.
- Results publication: PubMed 30361864Van Overwalle F, Van de Steen F, Marien P. Dynamic causal modeling of the effective connectivity between the cerebrum and cerebellum in social mentalizing across five studies. Cogn Affect Behav Neurosci. 2019 Feb;19(1):211-223. doi: 10.3758/s13415-018-00659-y.
- Results publication: PubMed 29903453Leggio M, Olivito G. Topography of the cerebellum in relation to social brain regions and emotions. Handb Clin Neurol. 2018;154:71-84. doi: 10.1016/B978-0-444-63956-1.00005-9.
- Results publication: PubMed 10576727Frith CD, Frith U. Interacting minds--a biological basis. Science. 1999 Nov 26;286(5445):1692-5. doi: 10.1126/science.286.5445.1692.
- Results publication: PubMed 20456660Mier D, Lis S, Neuthe K, Sauer C, Esslinger C, Gallhofer B, Kirsch P. The involvement of emotion recognition in affective theory of mind. Psychophysiology. 2010 Nov;47(6):1028-39. doi: 10.1111/j.1469-8986.2010.01031.x.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS in people with Autism Spectrum Disorder, run by Beatriz Catoira at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Beatriz Catoira, Msc (+32456267472, Beatriz.catoira@vub.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PS_RT (time frame: assessment will begin 10 minutes after stimulation and last up to 15 minutes). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05781412, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2023.