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Cerebellum and Autism: Regional Specialization for Social and Executive Functions

Sponsor
American University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05396352
Collaborator
National Institutes of Health (NIH) (NIH), National Institute of Mental Health (NIMH) (NIH)
80
Enrollment
1
Location
2
Arms
36
Anticipated Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Transcranial direct current stimulation
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Within-subjects design (active, sham tDCS) with separate groups receiving tDCS targeting cerebellar right lobule VII and the posterior cerebellar vermis.Within-subjects design (active, sham tDCS) with separate groups receiving tDCS targeting cerebellar right lobule VII and the posterior cerebellar vermis.
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Cerebellum and Autism: Regional Specialization for Social and Executive Functions
Actual Study Start Date :
Jan 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
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.

Device: 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.
Other Names:
  • 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.

    Device: 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.
    Other Names:
  • tDCS

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Reading the Mind in the Eyes Test Adult Version [Within 30min post-tDCS]

    2. Cyberball social ball-playing task [Within 30min post-tDCS]

    3. Flexible Item Selection Test [Within 30min post-tDCS]

    4. Functional MRI data [Within 45min post-tDCS]

      Functional MRI task data and resting state functional connectivity data

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 35 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 American University Washington District of Columbia United States 20016

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Catherine Stoodley, D.Phil., American University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Catherine Stoodley, Associate Professor, American University
    ClinicalTrials.gov Identifier:
    NCT05396352
    Other Study ID Numbers:
    • R15MH126404
    • R15MH126404
    First Posted:
    May 31, 2022
    Last Update Posted:
    Jun 1, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Autistic Disorder
    Autism Spectrum Disorder

    Study Results

    No Results Posted as of Jun 1, 2022