Recruiting

Neuromodulation

Sponsor:

American University

Code:

NCT05396352

Conditions

Autism

Autism Spectrum Disorder

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Accepted

Interventions

Transcranial direct current stimulation

Study Details

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.

Conditions

Autism

Autism Spectrum Disorder

Study ID

NCT05396352

Start date

Jan 1, 2022

Status verified date

Sep, 2025

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: 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.

experimental: 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.

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.

Primary outcome measure

  • Reading the Mind in the Eyes Test Adult Version [ Time Frame: Within 30min post-tDCS ]
  • Cyberball social ball-playing task [ Time Frame: Within 30min post-tDCS ]
  • Flexible Item Selection Test [ Time Frame: Within 30min post-tDCS ]
  • Functional MRI data [ Time Frame: Within 45min post-tDCS ]

Central Contacts and Locations

Central contacts

Catherine Stoodley, D.Phil.

202-476-4799stoodley@american.edu

Joe Dust, M.Sc.

jd7958a@american.edu

Locations

American University

Recruiting

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

Contacts

Catherine Stoodley, D.Phil.

202-885-1785stoodley@american.edu

Principal Investigator:

Catherine Stoodley

More Information

Sponsor

American University

Last update posted

Oct 2, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by American University on 2025-10-02.