Cerebellum and Autism: Regional Specialization for Social and Executive Functions

NCT ID: NCT05396352

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2025-12-31

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.

Detailed Description

Autism spectrum disorder is a prevalent neurodevelopmental condition characterized by deficits in social communication and the presence of repetitive and inflexible behaviors. There are currently few biologically-targeted treatment options for autism, in part because the underlying neurobiology is not well understood. One region of the brain that is consistently implicated in autism is the cerebellum. Specifically, two cerebellar subregions show structural and functional differences in autism: right cerebellar lobule VII (RVII) and the posterior cerebellar vermis. Based on the different anatomical connectivity of these regions, the investigators hypothesize that RVII and the posterior vermis regulate different core deficits in autism. In this study, the investigators combine cerebellar neuromodulation with functional neuroimaging to test the hypothesis that neuromodulation targeting RVII will selectively alter social learning and neural networks supporting social behavior, while neuromodulation targeting the posterior vermis will impact cognitive flexibility and neural networks involved in the allocation of attention. Neurotypical adults and adults with autism will complete social and cognitive flexibility tasks after excitatory, inhibitory, or sham neuromodulation in a within-subjects design. Some participants will receive neuromodulation targeting RVII and others will receive neuromodulation targeting the posterior vermis. The investigators will acquire functional brain imaging data during and after cerebellar neuromodulation, which will allow the team to better understand the mechanisms by which non-invasive neuromodulation might impact behavior in clinical disorders.

Conditions

Autism; Autism Spectrum Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Right cerebellum

Participants (neurotypical, autistic) in this arm will receive tDCS targeting the right posterolateral cerebellum (lobule VII). All participants will receive anodal, cathodal and sham tDCS.

Group Type: EXPERIMENTAL

Transcranial direct current stimulation

Intervention Type: DEVICE

TDCS involves applying small (1-2 mA) electric currents to the scalp in order to transiently modify local neuronal electrical potentials in the brain.

Posterior vermis

Participants (neurotypical, autistic) in this arm will receive tDCS targeting the posterior cerebellar vermis. All participants will receive anodal, cathodal and sham tDCS.

Group Type: EXPERIMENTAL

Transcranial direct current stimulation

Intervention Type: DEVICE

TDCS involves applying small (1-2 mA) electric currents to the scalp in order to transiently modify local neuronal electrical potentials in the brain.

Interventions

Transcranial direct current stimulation

TDCS involves applying small (1-2 mA) electric currents to the scalp in order to transiently modify local neuronal electrical potentials in the brain.

Intervention Type: DEVICE

Other Intervention Names

tDCS

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

American University

OTHER

Sponsor Role: lead

Responsible Party

Catherine Stoodley

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kathleen Gunthert, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

American University

Locations

American University

Washington D.C., District of Columbia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Catherine Stoodley, D.Phil.

Role: CONTACT

stoodley@american.edu

202-476-4799

Joe Dust, M.Sc.

Role: CONTACT

jd7958a@american.edu

Facility Contacts

Catherine Stoodley, D.Phil.

Role: primary

stoodley@american.edu

202-885-1785

Other Identifiers

R15MH126404

Identifier Type: NIH

Identifier Source: secondary_id

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R15MH126404

Identifier Type: NIH

Identifier Source: org_study_id

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