Cerebellum and Autism: Regional Specialization for Social and Executive Functions

Autism Spectrum Disorder Clinical Trial

Official title:

Cerebellum and Autism: Regional Specialization for Social and Executive Functions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05396352
• Other study ID #: R15MH126404
• Secondary ID: R15MH126404
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: July 2023
• Source: American University
• Contact: Catherine Stoodley, D.Phil.
• Phone: 202-885-1785
• Email: stoodley[@]american.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism
• Autism Spectrum Disorder
• Autistic Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	American University	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
American University	National Institute of Mental Health (NIMH), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reading the Mind in the Eyes Test Adult Version		Within 30min post-tDCS
Primary	Cyberball social ball-playing task		Within 30min post-tDCS
Primary	Flexible Item Selection Test		Within 30min post-tDCS
Primary	Functional MRI data	Functional MRI task data and resting state functional connectivity data	Within 45min post-tDCS