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

NCT05781412 | Unknown

• 1 other identifier: 22064MACA
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Keywords

tDCS; Cerebellum; neuromodulation; autism

Outcome Measures

Primary Outcomes (8)

• PS_RT

  Reaction Time in the pictorial sequencing time

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

• PS_accuracy

  Accuracy in the pictorial sequencing task

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

• ER_RT

  Reaction Times in the emotion recognition task

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

• ER_accuracy

  Accuracy in the emotion recognition task

  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...)

  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...)

  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...)

  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

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

Secondary Outcomes (6)

• 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

Other Outcomes (2)

• Electrical Field Simulations

  First 10 minutes of assessment

• Correlations between DWI, behavioural data, simulation and functional data

  assessment will include data from the 60 minutes that are spent in the scanner in the session

Study Arms (6)

ASD_anodalstimulation

ACTIVE COMPARATOR

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

Device: tDCS

ASD_shamstimulation

SHAM COMPARATOR

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

Device: tDCS

NT_anodalstimulation

ACTIVE COMPARATOR

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

Device: tDCS

NT_shamstimulation

SHAM COMPARATOR

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

Device: tDCS

H-AQ_anodalstimulation

ACTIVE COMPARATOR

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

Device: tDCS

H-AQ_shamstimulation

SHAM COMPARATOR

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

Device: tDCS

Interventions

tDCS DEVICE

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

ASD_anodalstimulation; ASD_shamstimulation; H-AQ_anodalstimulation; H-AQ_shamstimulation; NT_anodalstimulation; NT_shamstimulation

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• Participants must be more than 18 years old
• normal eyesight and hearing;
• Dutch, French or English speaking;
• 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;
• Patients with a formal diagnosis of high-functioning ASD as determined by the clinical psychologist/psychiatrist.

Sponsors & Collaborators

• Beatriz Catoira: lead
• Vrije Universiteit Brussel: collaborator
• University Ghent: collaborator
• Universitair Ziekenhuis Brussel: collaborator

Study Sites (1)

UZ Brussel

Jette, Brussels Capital, 1090, Belgium

RECRUITING

Related Publications (26)

• 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.

  PMID: 24076206 RESULT

• Buckner 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.

  PMID: 21795627 RESULT

• Murphy 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.

  PMID: 27462160 RESULT

• Murphy 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.

  PMID: 20969835 RESULT

• D'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.

  PMID: 26594140 RESULT

• Fatemi 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.

  PMID: 22370873 RESULT

• Sathyanesan 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.

  PMID: 30923348 RESULT

• Heleven 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.

  PMID: 31366954 RESULT

• Van 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.

  PMID: 30361864 RESULT

• Leggio 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.

  PMID: 29903453 RESULT

• Frith CD, Frith U. Interacting minds--a biological basis. Science. 1999 Nov 26;286(5445):1692-5. doi: 10.1126/science.286.5445.1692.

  PMID: 10576727 RESULT

• Mier 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.

  PMID: 20456660 RESULT

• Baron-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.

  PMID: 2934210 RESULT

• Leggio 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.

  PMID: 18334535 RESULT

• Izard 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.

  PMID: 11294223 RESULT

• Uljarevic M, Hamilton A. Recognition of emotions in autism: a formal meta-analysis. J Autism Dev Disord. 2013 Jul;43(7):1517-26. doi: 10.1007/s10803-012-1695-5.

  PMID: 23114566 RESULT

• Kennedy DP, Adolphs R. The social brain in psychiatric and neurological disorders. Trends Cogn Sci. 2012 Nov;16(11):559-72. doi: 10.1016/j.tics.2012.09.006. Epub 2012 Oct 6.

  PMID: 23047070 RESULT

• Morya E, Monte-Silva K, Bikson M, Esmaeilpour Z, Biazoli CE Jr, Fonseca A, Bocci T, Farzan F, Chatterjee R, Hausdorff JM, da Silva Machado DG, Brunoni AR, Mezger E, Moscaleski LA, Pegado R, Sato JR, Caetano MS, Sa KN, Tanaka C, Li LM, Baptista AF, Okano AH. Beyond the target area: an integrative view of tDCS-induced motor cortex modulation in patients and athletes. J Neuroeng Rehabil. 2019 Nov 15;16(1):141. doi: 10.1186/s12984-019-0581-1.

  PMID: 31730494 RESULT

• Ferrucci R, Priori A. Transcranial cerebellar direct current stimulation (tcDCS): motor control, cognition, learning and emotions. Neuroimage. 2014 Jan 15;85 Pt 3:918-23. doi: 10.1016/j.neuroimage.2013.04.122. Epub 2013 May 9.

  PMID: 23664951 RESULT

• O'Reilly JX, Beckmann CF, Tomassini V, Ramnani N, Johansen-Berg H. Distinct and overlapping functional zones in the cerebellum defined by resting state functional connectivity. Cereb Cortex. 2010 Apr;20(4):953-65. doi: 10.1093/cercor/bhp157. Epub 2009 Aug 14.

  PMID: 19684249 RESULT

• van Dun K, Bodranghien FC, Marien P, Manto MU. tDCS of the Cerebellum: Where Do We Stand in 2016? Technical Issues and Critical Review of the Literature. Front Hum Neurosci. 2016 May 11;10:199. doi: 10.3389/fnhum.2016.00199. eCollection 2016.

  PMID: 27242469 RESULT

• Oldrati V, Schutter DJLG. Targeting the Human Cerebellum with Transcranial Direct Current Stimulation to Modulate Behavior: a Meta-Analysis. Cerebellum. 2018 Apr;17(2):228-236. doi: 10.1007/s12311-017-0877-2.

  PMID: 28786014 RESULT

• Santiesteban I, Banissy MJ, Catmur C, Bird G. Enhancing social ability by stimulating right temporoparietal junction. Curr Biol. 2012 Dec 4;22(23):2274-7. doi: 10.1016/j.cub.2012.10.018. Epub 2012 Nov 1.

  PMID: 23122848 RESULT

• Hogeveen J, Obhi SS, Banissy MJ, Santiesteban I, Press C, Catmur C, Bird G. Task-dependent and distinct roles of the temporoparietal junction and inferior frontal cortex in the control of imitation. Soc Cogn Affect Neurosci. 2015 Jul;10(7):1003-9. doi: 10.1093/scan/nsu148. Epub 2014 Dec 5.

  PMID: 25481003 RESULT

• Rogers TD, McKimm E, Dickson PE, Goldowitz D, Blaha CD, Mittleman G. Is autism a disease of the cerebellum? An integration of clinical and pre-clinical research. Front Syst Neurosci. 2013 May 10;7:15. doi: 10.3389/fnsys.2013.00015. eCollection 2013.

  PMID: 23717269 RESULT

• Yeung MK, Lee TL, Chan AS. Impaired Recognition of Negative Facial Expressions is Partly Related to Facial Perception Deficits in Adolescents with High-Functioning Autism Spectrum Disorder. J Autism Dev Disord. 2020 May;50(5):1596-1606. doi: 10.1007/s10803-019-03915-3.

  PMID: 30758693 RESULT

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Central Study Contacts

Beatriz Catoira, Msc

CONTACT

+32456267472; Beatriz.catoira@vub.be

Nathalie Vanderbruggen

CONTACT

02/ 4763599; Nathalie.Vanderbruggen@uzbrussel.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MsC, PhD student at the Vrije Universiteit Brussel

Model Details: 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).

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: March 23, 2023
• Study Start: May 24, 2022
• Primary Completion: March 1, 2024
• Study Completion: October 30, 2024
• Last Updated: April 7, 2023

Record last verified: 2023-04

Locations

BE (1)