[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05396352":3,"trial-entities:NCT05396352":107,"trial-summary:NCT05396352":110},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":38,"secondary_outcomes":50,"sex":51,"minimum_age":52,"maximum_age":53,"healthy_volunteers":54,"eligibility_criteria":55,"std_ages":76,"locations":78,"central_contacts":96,"overall_officials":102,"references":105,"see_also_links":106},"NCT05396352","R15MH126404","Cerebellum and Autism: Regional Specialization for Social and Executive Functions","RECRUITING","2025-12-31","2025-09","2025-10-02","2022-01-01","American University","OTHER",false,"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.","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.",[18,19],"Autism","Autism Spectrum Disorder",[],"INTERVENTIONAL","BASIC_SCIENCE",[24],"NA",{"count":26,"type":27},80,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":36},"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.",[34,35],"Posterior vermis","Right cerebellum",[37],"tDCS",[39,42,44,46],{"measure":40,"timeFrame":41},"Reading the Mind in the Eyes Test Adult Version","Within 30min post-tDCS",{"measure":43,"timeFrame":41},"Cyberball social ball-playing task",{"measure":45,"timeFrame":41},"Flexible Item Selection Test",{"measure":47,"description":48,"timeFrame":49},"Functional MRI data","Functional MRI task data and resting state functional connectivity data","Within 45min post-tDCS",[],"ALL","18 Years","35 Years",true,{"inclusion":56,"exclusion":67,"raw_text":75},[57,58,59,60,61,62,63,64,65,66],"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)","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",[68,69,70,71,72,73,68,74,69,70,73],"Age \\\u003C18 or \\>35","NIH Toolbox age-adjusted Cognitive Function Composite standard score \\\u003C 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","Participants with a legal authorized representative","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.\n\nInclusion Criteria:\n\nAll participants\n\n* Aged 18-35\n* Able to provide written, informed consent\n* NIH Toolbox age-adjusted Cognitive Function Composite standard score ≥ 85\n* Native English speaker\n* Right-handed\n* Not pregnant\n* Able to attend all study sessions\n* Pass safety screening for MRI and neuromodulation (e.g. no metal in body, implanted devices, history of seizure, claustrophobia)\n\nAdditional INCLUSION criteria for adults with autism Either\n\n* Prior research-reliable diagnosis of autism spectrum disorder (ASD) Or\n* Meet DSM-5 criteria for ASD confirmed with ADOS-2 via research-reliable clinical assessment\n\nExclusion Criteria:\n\nNeurotypical adults\n\n* Age \\\u003C18 or \\>35\n* NIH Toolbox age-adjusted Cognitive Function Composite standard score \\\u003C 85\n* Contraindications for MRI or neuromodulation with tDCS (e.g. metal in body, pacemaker or other implanted device, history of seizure, claustrophobia)\n* Current or prior history of neurological or neurodevelopmental condition or brain injury\n* Psychotropic medication\n* Pregnancy\n\nAdults with autism\n\n* Age \\\u003C18 or \\>35\n* Participants with a legal authorized representative\n* NIH Toolbox age-adjusted Cognitive Function Composite standard score \\\u003C 85\n* Contraindications for MRI or neuromodulation with tDCS (e.g. metal in body, pacemaker or other implanted device, history of seizure, claustrophobia)\n* Pregnancy",[77],"ADULT",[79],{"facility":12,"status":7,"city":80,"state":81,"zip":82,"country":83,"contacts":84,"geoPoint":93},"Washington D.C.","District of Columbia","20016","United States",[85,90],{"name":86,"role":87,"phone":88,"email":89},"Catherine Stoodley, D.Phil.","CONTACT","202-885-1785","stoodley@american.edu",{"name":91,"role":92},"Catherine Stoodley","PRINCIPAL_INVESTIGATOR",{"lat":94,"lon":95},38.89511,-77.03637,[97,99],{"name":86,"role":87,"phone":98,"email":89},"202-476-4799",{"name":100,"role":87,"email":101},"Joe Dust, M.Sc.","jd7958a@american.edu",[103],{"name":104,"affiliation":12,"role":92},"Kathleen Gunthert, Ph.D.",[],[],{"nct_id":4,"conditions":108,"biomarkers":109},[19],[],{"nct_id":4,"found":54,"summary":111,"prompt_version":120},{"design":112,"status":113,"heading":6,"summary":114,"follow_up":115,"word_count":116,"commitments":117,"compensation":118,"drugs_mentioned":119},"This interventional study plans to enroll 80 participants, including both neurotypical adults and adults with autism. Participants will receive different types of neuromodulation (excitatory, inhibitory, or sham) in a within-subjects design.","completed","This study is exploring how a brain stimulation technique called transcranial direct current stimulation (tDCS) affects social and thinking skills in young adults with and without autism. Researchers are applying small electrical currents to specific areas of the cerebellum, a part of the brain, to see if it changes how people perform on tasks related to social interaction and flexible thinking. They will measure your performance on tests like the Reading the Mind in the Eyes Test, a social ball-playing game called Cyberball, and a flexible thinking test after receiving tDCS. The study is looking for 80 participants, aged 18-35, who live in the Washington, DC area. The study's status is currently unclear.","Participants' responses to the interventions are measured within 30 minutes after receiving tDCS.",113,"Participants will complete social and cognitive flexibility tasks after receiving transcranial direct current stimulation (tDCS). The primary endpoints are measured within 30 minutes post-tDCS.","Not stated in the trial record.",[31],"v2"]