Impact of cerebellum neuromodulation on social and executive functions in autism

Cerebellum and Autism: Regional Specialization for Social and Executive Functions

This study is testing how a brain stimulation technique affects social skills and thinking abilities in young adults with autism and those without it.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 35 Years
• Sex: All
• Sponsor: American University (Academic / other)
• Locations: 1 site (Washington D.C., District of Columbia)
• Trial ID: NCT05396352 on ClinicalTrials.gov

What this trial studies

This study aims to explore how neuromodulation of the cerebellum affects social and executive functions in both neurotypical young adults and those with autism. Researchers will utilize transcranial direct current stimulation to target specific cerebellar regions, hypothesizing that different areas influence distinct cognitive abilities. Participants will undergo various tasks assessing social learning and cognitive flexibility after receiving either excitatory, inhibitory, or sham stimulation. The study will also incorporate functional neuroimaging to observe changes in brain activity related to these functions.

Who should consider this trial

Good fit: Ideal candidates are young adults aged 18-35, both neurotypical and those diagnosed with autism spectrum disorder.

Not a fit: Patients outside the age range of 18-35 or those with cognitive function scores below the required threshold may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to targeted neuromodulation therapies that improve social and cognitive functions in individuals with autism.

How similar studies have performed: While the approach of targeting cerebellar regions is innovative, similar studies have shown promise in neuromodulation techniques for cognitive and social function improvements.

Eligibility criteria

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

Where this trial is running

Washington D.C., District of Columbia

• American University — Washington D.C., District of Columbia, United States (Recruiting)

Study contacts

• Principal investigator: Kathleen Gunthert, Ph.D. — American University
• Study coordinator: Catherine Stoodley, D.Phil.

Conditions Autism; Autism Spectrum Disorder