Cerebellum and Autism: Regional Specialization for Social and Executive Functions
1 other identifier
interventional
80
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2022
CompletedFirst Submitted
Initial submission to the registry
May 25, 2022
CompletedFirst Posted
Study publicly available on registry
May 31, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedOctober 2, 2025
September 1, 2025
4 years
May 25, 2022
September 29, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
Reading the Mind in the Eyes Test Adult Version
Within 30min post-tDCS
Cyberball social ball-playing task
Within 30min post-tDCS
Flexible Item Selection Test
Within 30min post-tDCS
Functional MRI data
Functional MRI task data and resting state functional connectivity data
Within 45min post-tDCS
Study Arms (2)
Right cerebellum
EXPERIMENTALParticipants (neurotypical, autistic) in this arm will receive tDCS targeting the right posterolateral cerebellum (lobule VII). All participants will receive anodal, cathodal and sham tDCS.
Posterior vermis
EXPERIMENTALParticipants (neurotypical, autistic) in this arm will receive tDCS targeting the posterior cerebellar vermis. All participants will receive anodal, cathodal and sham tDCS.
Interventions
TDCS involves applying small (1-2 mA) electric currents to the scalp in order to transiently modify local neuronal electrical potentials in the brain.
Eligibility Criteria
You may qualify if:
- 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)
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- American Universitylead
- National Institutes of Health (NIH)collaborator
- National Institute of Mental Health (NIMH)collaborator
Study Sites (1)
American University
Washington D.C., District of Columbia, 20016, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kathleen Gunthert, Ph.D.
American University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
May 25, 2022
First Posted
May 31, 2022
Study Start
January 1, 2022
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
October 2, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Data uploaded to NDAR will be released following study completion
- Access Criteria
- * Access to NDAR * Individuals wishing to use these data must agree not to attempt to identify participants or redistribute the data, to destroy the data after analyses are completed, and to acknowledge the data resource in any presentations or publications.
De-identified data, including scores of behavioral tests and skull-stripped brain images, may be shared upon personal request after initial manuscripts based on this work have been published. Individuals wishing to use these data must agree not to attempt to identify participants or redistribute the data, to destroy the data after analyses are completed, and to acknowledge the data resource in any presentations or publications. For participants that consent to having their de-identified data shared with the National Database for Autism Research (NDAR), we will submit data to NDAR in accordance with the NIH guidelines (http://ndar.nih.gov/contribute.html).