Cerebellum and Autism: Regional Specialization for Social and Executive Functions
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transcranial direct current stimulation.
- Who it may be relevant to
- Registry conditions: Autism, Autism Spectrum Disorder. Basic parameters: 18 years — 35 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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.
Primary outcome measures
- 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]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- American University — Washington D.C.
Identifiers
NCT: NCT05396352 · R15MH126404 · R15MH126404