[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"asperger-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:asperger-syndrome":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,53,85,111,134],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":33,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100533589","alpha-auditory-entrainment-for-cognitive-enhancement-and-sensory-hypersensitivity-in-youth-with-developmental-disorders-100533589",false,"NCT06227780","Alpha Auditory Entrainment for Cognitive Enhancement and Sensory Hypersensitivity in Youth With Developmental Disorders","FX ENTRAIN: Perturbation of Neurodynamics Underlying Sensory Hyperarousal and Statistical Learning in Youth With FXS","ENTRAIN","Inclusion Criteria:\n\n* FXS Cohort: 1) Aged 5-10 years, inclusive; 2) Patient has full FMR1 mutation confirmed by genetic testing.\n* ASD Cohort: 1) Aged 5-10 years, inclusive; 2) Have no known genetic mutation; 3) Have documentation of ASD diagnosis; 4) Score ≤ 15 on SCQ screen; 5) Be in good health per investigator.\n* TDC Cohort: 1) Aged 5-10 years, inclusive; 2) Have no known genetic mutation; 3) Have documentation of ASD diagnosis; 4) Score ≤ 15 on SCQ screen; 5) Be in good health per investigator; 6) Patient has met normal developmental milestones; Patient has no family history of heritable neuropsychiatric disorders; 7) Patient has an IQ greater than 85 on the Stanford-Binet; 8) Score ≤8 on an SCQ screen.\n\nExclusion Criteria:\n\n* All subjects: 1) Patient has auditory or visual impairments that cannot be corrected; 2) History of substance abuse or dependence within the past 6 months",true,"ALL","5 Years","10 Years",{"count":22,"type":23},180,"ESTIMATED","INTERVENTIONAL",[26],"NA","Fragile X Syndrome (FXS) is a complex neurodevelopmental disorder caused by a mutation on the X chromosome. Scientists have investigated FXS extensively in both humans and animals. Thus far, phenotypic rescue in animal models has not resulted in treatment breakthroughs in humans, though some important discoveries have been made. Research has shown that individuals with FXS process sounds differently than those in the typical population, and they also show baseline differences in brain activity, including high gamma activity, increased theta activity, and decreased alpha activity. The investigators' central hypothesis is that these alterations in brain activity (specifically alpha and gamma activity) impair the brain's ability to process new information, thereby impeding cognitive functioning and increasing sensory sensitivity. The investigators propose that auditory entrainment, a technique that involves playing special sounds through headphones, will normalize brain activity in individuals with FXS and lead to increased cognitive function and decreased sensory hypersensitivity.",[29,30,31,32],"Fragile X Syndrome","Autism Spectrum Disorder","Autistic Disorder","Asperger Syndrome",[34,31,30,29,35,36,37,38,39],"Neurodevelopmental Disorders","Fragile X","FXS","ASD","Asperger","Autism","RECRUITING","2026-03-25",{"date":43,"type":44},"2026-03-30","ACTUAL",{"date":46,"type":44},"2023-05-24",{"date":48,"type":23},"2028-05-24",{"name":50,"class":51},"Children's Hospital Medical Center, Cincinnati","OTHER",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":18,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":4,"studyType":24,"phases":64,"briefSummary":65,"conditions":66,"keywords":72,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":52},"100452845","telehealth-parent-implemented-intervention-for-young-children-with-autism-spectrum-disorder-asd-100452845","NCT05176808","Telehealth Parent-Implemented Intervention for Young Children With Autism Spectrum Disorder (ASD)","Telehealth Parent-Implemented Intervention to Improve Social- Communication Outcomes in Young Children With ASD","Inclusion Criteria:\n\n* Meeting study criteria for ASD based on:\n\n  * Autism Diagnostic Observation Schedule(ADOS) criteria for mild-to- moderate concern or greater (for children between 18 and 30 months) or algorithm cut-offs for ASD or autism (31-33 months),\n  * Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5)( criteria for ASD)\n  * ASD diagnosis by clinician (clinical best estimate) by study team clinical research experts\n* Meeting study criteria for social communication delay based on:\n\n  * Scoring a T score of \\\u003C35 on Expressive Language and\u002For Receptive Language subscales, Nonverbal developmental quotient of \\> 50 (Visual Reception and Fine Motor subscales averaged) AND Visual reception \\> 12 months\n* Nonverbal developmental quotient (DQ) of \\> 63 based on the Visual Reception and Fine Motor subscales\n* Gestational age of 36-42 weeks;\n* Birth weight of \\> 2,500 grams;\n* Absence of identifiable neurological (e.g., epilepsy), genetic (e.g., Down syndrome, fragile X, tuberose sclerosis, neurofibromatosis) or severe sensory- motor (e.g., cerebral palsy) conditions.\n* Able to walk independently.\n* Children must produce at least three different types of intentional directed (with eye contact or pairing vocalization and gesture) nonverbal or verbal communicative acts per day, with clear and specific examples, per parent report in the Eligibility Interview.\n\nExclusion Criteria:\n\n* Having a primary language other than English\n* Family lives \\>40 miles from a Kennedy Krieger Institute-Center for Autism Services, Sciences, and Innovation (CASSI) site.\n* Child lives in foster care.","18 Months","42 Months",{"count":63,"type":23},188,[26],"The primary objective of this research study is to improve outcomes involving core social-communication symptoms for young children with ASD or social communication delays by increasing access to clinically validated early behavioral intervention through a telehealth parent coaching model. The investigators will test the hypothesis that telehealth-delivered Naturalistic Developmental Behavioral Intervention parent coaching (TC) is non-inferior to in-person coaching (IPC) for the treatment of core social-communication symptoms in toddlers with either a social communication delay or ASD.",[30,31,67,39,32,68,69,70,71],"Active Autistic Disorder","PDD-NOS","Social Communication Delay","Mixed Expressive Receptive Language Disorder","Other Symbolic Dysfunctions",[73,74,75],"Social Communication","Language","Engagement","2026-03-20",{"date":78,"type":44},"2026-03-24",{"date":80,"type":44},"2022-02-07",{"date":82,"type":23},"2026-12-01",{"name":84,"class":51},"Hugo W. Moser Research Institute at Kennedy Krieger, Inc.",{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":18,"minAge":92,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":24,"phases":95,"briefSummary":96,"conditions":97,"keywords":98,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":52},"100582177","randomized-clinical-trial-of-tune-in-30-a-socialemotional-program-for-adults-with-autism-spectrum-disorder-100582177","NCT06859918","Randomized Clinical Trial of TUNE In 3.0: A Social\u002FEmotional Program for Adults With Autism Spectrum Disorder","ASPE Subproject - Training to Understand and Navigate Emotions and Interactions (TUNE In)","Inclusion Criteria:\n\n* 18 years of age or older\n* Meet ASD diagnostic criteria supported by an outside diagnostic evaluation and\u002For by the clinical and developmental information gathered from a phone screen\n* Be willing to complete screening surveys (outcome measures)\n* Social Responsiveness Score, Second Edition, self-report SRS survey score of greater than or equal to 60\n\nExclusion Criteria:\n\n* Severe self-injurious or aggressive behaviors; or with suicidal or homicidal ideation or behaviors (e.g. suicide attempt) within the last 6 months\n* Major mood episode (major depressive episode, manic episode), psychotic symptoms, or a psychiatric hospitalization within the last 6 months\n* A history of intellectual disability or low Shipley-2 score","18 Years",{"count":94,"type":23},40,[26],"The purpose of this study is to test a novel, cognitive behavioral treatment strategy to improve social functioning in adults with autism spectrum disorder.\n\nThe treatment, named TUNE In (Training to Understand and Navigate Emotions and Interactions), includes components to address the many behavioral domains involved in social functioning, including social motivation, social anxiety, social cognition, social skills, and generalization of the skills to community settings.\n\nThe Investigators will test the efficacy of TUNE In to improve social functioning in adults with autism spectrum disorder (ASD), using a randomized controlled trial using the SRS-2 as the primary outcome measure.",[30,39,31,32],[99,100,101],"Social Skills","Emotion Regulation","Autistic Adults","2026-03-11",{"date":104,"type":44},"2026-03-13",{"date":106,"type":44},"2025-03-24",{"date":108,"type":23},"2027-12",{"name":110,"class":51},"University of Pennsylvania",{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":18,"minAge":118,"maxAge":119,"enrollmentInfo":120,"targetDuration":4,"studyType":24,"phases":122,"briefSummary":123,"conditions":124,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":52},"100403371","transcranial-magnetic-stimulation-for-restricted-and-repetitive-behavior-in-asd-100403371","NCT04532424","Transcranial Magnetic Stimulation for Restricted and Repetitive Behavior in ASD","TMS for ASD","Inclusion criteria.\n\n1. Diagnosis of Autism Spectrum Disorder (ASD)\n2. Meet criteria for Autism Spectrum Disorder (ASD) on clinical assessments (ADOS-2 or CARS if conducted remotely \\& ADI-R)\n3. Aged between 12-45 years old\n4. Have a reliable informant who can complete relevant questionnaires\n5. Have DARB scores which indicate high levels (50% or above) of RRB on one of the following domains: Insistence on Sameness, Obsessive Compulsive Behaviors, and Unusual Interests\n\nExclusion criteria.\n\n1. Any contraindications for TMS e.g. history of seizures other than clear substance-induced\u002Ffever-induced seizures with neurologist note or normal clean EEG and no seizure in at least 12 months prior to enrollment.\n2. Pregnancy.\n3. Any current or past history of any physical condition which in the investigator's opinion might put the subject at risk or interfere with study results interpretation.\n4. Active substance use (\\\u003C1 week) or intoxication verified by toxicology screen--of cocaine, amphetamines, benzodiazepines.\n5. Showing symptoms of withdrawal from alcohol or benzodiazepines.\n6. DSM-5 diagnosis of bipolar disorder or a psychotic disorder e.g. schizophrenia.\n7. Significant sensory impairments such as blindness or deafness.\n8. Current severe insomnia (must sleep a minimum of 4 hours the night before stimulation).\n9. Not willing to cooperate with the TMS procedures.\n10. Currently taking Clozapine or another medication that the PI determines increases the risk of TMS or may disrupt the efficacy.\n11. A motor threshold that is too high to allow safe\u002Ftolerable treatment.\n12. Conditions that increase the risk for COVID-19 (in accordance with university guidelines).","12 Years","45 Years",{"count":121,"type":23},67,[26],"Investigating the efficacy of a form of TMS called theta-burst stimulation for restricted and repetitive behavior in ASD.",[30,39,32],"2025-08-16",{"date":127,"type":44},"2025-08-19",{"date":129,"type":44},"2021-01-04",{"date":131,"type":23},"2029-12-01",{"name":133,"class":51},"Stanford University",{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":140,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":18,"minAge":92,"maxAge":142,"enrollmentInfo":143,"targetDuration":4,"studyType":24,"phases":145,"briefSummary":146,"conditions":147,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":52},"100530462","the-supplementation-therapy-in-autism-and-response-to-treatment-study-100530462","NCT06187090","The Supplementation Therapy in Autism and Response to Treatment Study","The Supplementation Therapy in Autism and Response to Treatment (START) Study","START","Inclusion Criteria:\n\n* Individuals diagnosed with Level 1 ASD, as defined using Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5);\n* Aged 18-35 years;\n* To be able to understand and communicate in Italian;\n* To be able to give informed consent.\n\nExclusion Criteria:\n\n* Level 2 or Level 3 ASD, as defined using Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5) \\[47\\];\n* Current diagnosis of a co-occurring major psychiatric disorder (e.g., major depressive disorder, bipolar affective disorder, psychotic disorders);\n* Active suicidal ideation indicating significant current risk or history of serious suicide attempt in the opinion of the PI, as evaluated at the screening stage;\n* Lifetime neurological disorders (e.g., epilepsy, except febrile convulsions) or severe intercurrent physical illness;\n* Current treatment with psychotropic medication, with the exception of Selective Serotonin Reuptake Inhibitor (SSRI) stable monotherapy (at least 8 months);\n* IQ \\\u003C 70;\n* Female patients who are pregnant, lactating or not using an acceptable effective form contraception if they are at risk of falling pregnant;\n* Taking part in another pharmacological trial.","35 Years",{"count":144,"type":23},20,[26],"In addition to the \"core\" symptoms of ASD (i.e., impaired communication, impaired reciprocal social interaction and restricted, repetitive and stereotyped patterns of behaviors or interests), it is estimated that up to 70% of autistic people present at least one comorbid psychiatric disorder, leading to a deterioration in quality of life, a greater demand for support and worse prognosis and outcome. Anxiety and depressive symptoms would seem to be more present in individuals with Level 1 ASD, requiring their prioritisation against core symptoms. To date, the first-line treatment for autistic patients with comorbid depressive and\u002For anxiety symptoms is still debated and it is not always clear whether they may or may not benefit from psychotherapeutic and conventional psychopharmacological approaches. As such, growing evidence strengthens the therapeutic potential of the endocannabinoid (eCB) system modulation and of eCB-like compounds.\n\nThe aim of this study is to provide a response to an unmet clinical need in this framework of psychic vulnerability by initiating oral therapy with palmitoylethanolamide (PEA), a nutraceutical\u002Ffood supplement with proven anti-inflammatory and neuroprotective properties.\n\nIndeed, many conditions of psychological distress are thought to be underpinned by systemic inflammatory and\u002For neuroinflammatory processes, on which PEA has shown remarkable efficacy, including through modulation of the immune response and the interaction between the endocannabinoid system and the gut-microbiota-brain axis.\n\nThe trial we are proposing is a 12-week open-label phase 2 study involving the daily intake of PEA 600 mg, at a dosage of 1 tablet\u002Fday.\n\nThis study will be conducted at the Unit of Psychiatry of Santa Maria della Misericordia Udine University Hospital.\n\nThrough this study, we wish to evaluate: the ability of PEA to alleviate symptoms of psychic distress (i.e., anxiety and\u002For depression) in Level 1 autistic adults; the safety and tolerability of sustained intake of PEA in Level 1 autistic adults; and the biological basis of PEA functioning.\n\nThe study involves taking PEA orally once daily (600 mg daily) at the same time as a meal during the initial 12-week phase. Upon completion of the initial phase, subjects will be offered to enter an extension phase of the trial of an additional 24 weeks to assess treatment stability, with the possibility of titration of PEA to 1200 mg daily based on observed clinical compensation. Each participant will be on PEA treatment for up to 36 weeks.\n\nDuring the course of the study, periodic clinical re-evaluations will be conducted at our Day-Hospital setting.\n\nThe trial will unfold through one screening visit, one baseline visit, and two follow-up visits (FUP, 4 weeks and 12 weeks apart). The patient will be administered standardized interviews by a qualified investigating physician; clinical objective examination, collection of blood and urine samples for standard hematochemical investigations, collection of blood and stool samples for analysis of some biological markers of interest, monitoring of adherence to therapy intake, side effects, and adverse effects will also be performed during the follow-up visits. The nutraceutical PEA will be dispensed by the clinical investigators at each follow-up visit.",[39,30,148,32,149,150],"Autism Spectrum Disorder High-Functioning","Depressive Symptoms","Anxiety State","2023-12-15",{"date":153,"type":44},"2024-01-02",{"date":155,"type":44},"2023-09-01",{"date":157,"type":23},"2026-11",{"name":159,"class":51},"University of Udine"]