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NCT Number: NCT05396352

Cerebellum and Autism: Regional Specialization for Social and Executive Functions

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.

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

American University

Washington D.C., District of Columbia, 20016, United States

Location status: Recruiting

Location contact

Catherine Stoodley

PRINCIPAL_INVESTIGATOR

Catherine Stoodley, D.Phil.

CONTACT

[email protected]

202-885-1785

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Please note: This study takes place at American University and Georgetown University in Washington, DC. We do not have funds for travel and lodging available for this study, so participants should be local to the DC region.

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)

Additional INCLUSION criteria for adults with autism Either

  • 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

Treatment and study plan

Transcranial Direct Current Stimulation

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.

Other names: tDCS

Primary outcomes

  1. Reading the Mind in the Eyes Test Adult Version

    Time frame: Within 30min post-tDCS

  2. Cyberball social ball-playing task

    Time frame: Within 30min post-tDCS

  3. Flexible Item Selection Test

    Time frame: Within 30min post-tDCS

  4. Functional MRI data

    Time frame: Within 45min post-tDCS

    Functional MRI task data and resting state functional connectivity data

Study contacts

Contact information is provided by the study sponsor or research team.

Catherine Stoodley, D.Phil.

CONTACT

[email protected]

202-476-4799

Joe Dust, M.Sc.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

American University

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
May 31, 2022
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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