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Clinical Trials/NCT05396352
NCT05396352
Recruiting
N/A

Cerebellum and Autism: Regional Specialization for Social and Executive Functions

American University1 site in 1 country80 target enrollmentJanuary 1, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Autism
Sponsor
American University
Enrollment
80
Locations
1
Primary Endpoint
Cyberball social ball-playing task
Status
Recruiting
Last Updated
7 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2022
End Date
December 31, 2025
Last Updated
7 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
American University
Responsible Party
Principal Investigator
Principal Investigator

Catherine Stoodley

Associate Professor

American University

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)
  • Additional INCLUSION criteria for adults with autism Either

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

Outcomes

Primary Outcomes

Cyberball social ball-playing task

Time Frame: Within 30min post-tDCS

Functional MRI data

Time Frame: Within 45min post-tDCS

Functional MRI task data and resting state functional connectivity data

Reading the Mind in the Eyes Test Adult Version

Time Frame: Within 30min post-tDCS

Flexible Item Selection Test

Time Frame: Within 30min post-tDCS

Study Sites (1)

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