[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"autism-spectrum-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:autism-spectrum-disorder":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,308,0,25,[9,51,87,116,142,162,182,209,237,255,275,313,337,357,386,408,432,460,496,518,546,571,593,615,640],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100594578","dbt-skill-training-for-autistic-adults-with-difficulties-in-emotion-regulation-100594578",false,"NCT07021274","DBT Skill Training for Autistic Adults With Difficulties in Emotion Regulation.","DBT Skill Training for Autistic Adults With Difficulties in Emotion Regulation: a Feasibility Study.","Inclusion Criteria:\n\n* Fit general inclusion criteria for the out- patient treatment at the clinic.\n* Have diagnosed autism, and pervasive difficulties in emotion regulation.\n* Speak Scandinavian (Norwegian, Danish and\u002For Swedish).\n* Manage to commit to participating in the DBT- skills training.\n* Be willing to sign the written informed consent.\n\nExclusion Criteria:\n\n* Have a clinically significant low linguistic functioning that hinders the patient in understanding and answering the questions on the self-report instruments.\n* Being actively psychotic.\n* Have a Body Mass Index (BMI) under 17.\n* Cognitive disability Intelliganve quotient (IQ) \\\u003C85","ALL","18 Years",{"count":20,"type":21},15,"ESTIMATED","INTERVENTIONAL",[24],"NA","One in 44 has autism, 70% of them have additional mental health challenges. Currently, this patient population does not have access to effective treatment within specialist healthcare services and has struggled to benefit from standard treatments. The goal of this project is to increase access to treatment tailored to their challenges. We will investigate whether a treatment program with an adapted version of Dialectical Behavior Therapy (DBT) is feasible, accepted, and perceived as useful for people with autism. The purpose of the treatment is to improve emotion regulation, function better in relationships, and avoid crises, thereby enhancing their ability to achieve personal goals, reduce suffering, and increase quality of life. Autism is a lifelong neurodevelopmental disorder, presenting with great variation and more widespread than previously thought. Difficulties with emotion regulation are a central challenge for many with autism. These difficulties often manifest as an inability to recognize, understand, and manage emotional responses, leading to destructive strategies, behaviors, and suffering. DBT is developed with a focus on emotion regulation and has shown good effects in other patient populations. The project can increase access to treatment for a patient population that currently stands without.",[27,28,29],"Difficulties of Emotion Regulation","Self-harm Behavior","Autism Spectrum Disorder",[31,32,33,34,35,36,37],"Autisim","emotion regulation","DBT skills training","adults","ASD","Feasibility","Autism spectrum disorder","RECRUITING","2026-06-26",{"date":41,"type":42},"2026-06-29","ACTUAL",{"date":44,"type":42},"2025-08-15",{"date":46,"type":21},"2027-02-28",{"name":48,"class":49},"Helse Møre og Romsdal HF","OTHER_GOV",1,{"id":52,"slug":53,"hasResults":12,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":12,"sex":17,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":62,"phases":4,"briefSummary":63,"conditions":64,"keywords":69,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":50},"100410940","developing-brain-impulsivity-and-compulsivity-100410940","NCT04631042","Developing Brain, Impulsivity and Compulsivity","An Observational Study of the Developing Brain, Impulsivity and Compulsivity","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Stated willingness to comply with all study procedures and availability for the duration of the study.\n2. Must be between 6 and 80 years of age.\n3. Ability of participant to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Cognitively not capable of performing study procedures or lack of capacity to provide informed consent. Indications of a lack of cognitive capacity could include a known full-scale IQ under 70, or a history from the screening interview that implies global intellectual disabilities (e.g., placement in a school for children with intellectual disability etc.)\n2. Very premature birth (i.e., birth before 32 weeks of gestational age).\n3. Any known brain abnormalities (e.g., tumor, periventricular leukomalacia, microcephaly) or history of medical conditions known to affect cerebral anatomy (e.g., epilepsy, history of stroke, head injury with a loss of consciousness of one hour or more).\n4. Psychotic disorders (including schizophrenia, psychosis not otherwise specified).\n5. Dementia, or other conditions that, in the opinion of the investigators, would impede compliance or possibly hinder completion of the study.\n6. Pregnant women.\n7. Any other medical or psychiatric condition that in the opinion of the PI may confound study data\u002Fassessments.\n\nAdditional exclusion criteria for optional MRI procedure:\n\n1\\. Individuals who are not able to receive an MRI (e.g., metal bioimplants, claustrophobia, inability to lie flat on their backs, pregnant women, and any other contraindications for MRI scanning according to the NMR Center MRI safety guidelines).","6 Years","80 Years",{"count":61,"type":21},1100,"OBSERVATIONAL","Background:\n\nImpulsivity is acting 'without thinking.' Compulsivity is being overly inflexible. People vary in how impulsive or compulsive they are. Extreme versions of these behaviors play a role in mental disorders. Researchers want to study changes in the brain to learn more about these behaviors. Differences in genes may also play a role.\n\nObjective:\n\nTo learn about genetic \\& brain features that explain why levels of impulsivity and compulsivity vary across people.\n\nEligibility:\n\nPeople ages 6 - 80\n\nDesign:\n\nParticipants will be screened with a medical history and medical record review.\n\nParticipants will talk about their mental and behavioral development. They may discuss topics like drug use and sexual activity. They will complete surveys about their compulsivity and impulsivity. Parents of child participants may also complete these surveys.\n\nParticipants may take memory, attention, and thinking tests. They may give blood or saliva samples for gene studies and they may give blood to make induced pluripotent stem cells. Participants may have their face and irises photographs taken.\n\nParticipants may have a magnetic resonance imaging scan. It will take pictures of their brain. The scanner is shaped like a cylinder. Participants will lie on a table that slides in and out of the scanner. A coil will be placed over their head. They will lie still, watch a movie, and play a game.\n\nParticipants may ask family members to join the study. Researchers are particularly interested in recruiting twin pairs to the study.\n\nParticipants under age 25 may repeat these tests every 1-2 years until they turn 25 or until the study ends. For those over age 25, participation will last less than 1 month.",[65,66,67,68,29],"Typical Development","Obsessive Compulsive Disorder","Conduct Disorder","Attention Deficit Hyperactivity Disorder",[70,71,72,73,74,75,76],"Neurodevelopmental disorder","Twin","Natural History","Heritability","Glutamate","developmental trajectory","Brain Connectivity","2026-06-24",{"date":79,"type":42},"2026-06-25",{"date":81,"type":42},"2022-09-30",{"date":83,"type":21},"2031-12-31",{"name":85,"class":86},"National Institute of Mental Health (NIMH)","NIH",{"id":88,"slug":89,"hasResults":12,"nctId":90,"briefTitle":91,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":94,"sex":17,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":4,"studyType":22,"phases":99,"briefSummary":100,"conditions":101,"keywords":104,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":50},"100543965","modified-pivotal-response-treatment-for-insistence-on-sameness-in-autistic-youth-100543965","NCT06362733","Modified Pivotal Response Treatment for Insistence on Sameness in Autistic Youth","M-PRT-IS","Participants will include children with:\n\n1. parent\u002Fguardian aged 18 years or older with a child aged between 4.0 to 17.11 years old at the time of parental consent;\n2. diagnosed with ASD (based on history, review of available medical records including diagnostic testing, e.g., ADOS) or suspicion of ASD diagnosis and confirmed with Autism Diagnostic Interview-Revised (ADI-R);\n3. parent-reported clinically significant concerns regarding insistence on sameness and behavioral inflexibility;\n4. stable behavioral and pharmacological treatment for at least two weeks with no anticipated changes;\n5. English-speaking parent and youth able to consistently participate in study procedures;\n6. family resides in United States.",true,"4 Years","17 Years",{"count":98,"type":21},44,[24],"The purpose of this open label trial is to examine the preliminary feasibility, acceptability, and effectiveness of a 12-week behavioral intervention program (1 hour\u002Fweek) to treat insistence on sameness (e.g., difficulty tolerating changes in routine) in youth with autism spectrum disorder (ASD). Treatment will be delivered via secure telemedicine platform and consist of a combination of parent-training and parent-mediated intervention with the child.",[29,102,103],"Restricted Behavior","Autism",[105,106],"Intervention","Pivotal Response Treatment","2026-06-22",{"date":79,"type":42},{"date":110,"type":42},"2024-07-11",{"date":112,"type":21},"2028-07-01",{"name":114,"class":115},"Stanford University","OTHER",{"id":117,"slug":118,"hasResults":12,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":12,"sex":17,"minAge":124,"maxAge":125,"enrollmentInfo":126,"targetDuration":4,"studyType":22,"phases":128,"briefSummary":129,"conditions":130,"keywords":131,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":136,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":50},"100431550","trial-of-center-based-vs-in-home-pivotal-response-treatment-prt-in-autism-100431550","NCT04899544","Trial of Center-Based vs. In-Home Pivotal Response Treatment (PRT) in Autism","Randomized Controlled Trial of Center-Based vs. In-Home Pivotal Response Treatment (PRT) in Autism","PRT-HvC","Inclusion Criteria:\n\n* Diagnosis of Autism Spectrum Disorder (ASD) based on Autism Diagnostic Interview Revised (ADI-R), Autism Diagnostic Observation Schedule, Second Edition (ADOS-2) or Childhood Autism Rating Scale, Second Edition (CARS-2), Diagnostic and Statistical Manual 5th Edition (DSM-5), and expert clinical opinion;\n* Boys and girls between 2.0 and 5.11 years;\n* Ability to participate in the testing procedures to the extent that valid standard scores can be obtained;\n* Language delay as measured by the Preschool Language Scale, 5th Edition (PLS-5): Standard score at least 1 standard deviation below average for expressive language ability for 2 and 3 year olds; 2 standard deviations for 4 year olds, and 3 standard deviations for 5 year olds;\n* Stable treatment (e.g., Applied Behavior Analysis - ABA), speech therapy, school placement, psychotropic medication(s) or biomedical intervention(s) for at least 1 month prior to baseline measurements;\n* No anticipated changes on treatment during study participation for Center-Based Pivotal Response Treatment (PRT-C) and In-Home Pivotal Response Treatment (PRT-H);\n* No more than 60 minutes of individual 1:1 speech therapy per week;\n* Availability of at least one parent or primary caregiver who can consistently participate in parent training and research measures.\n\nExclusion Criteria:\n\n* Current or lifetime diagnosis of severe psychiatric disorder (e.g., bipolar disorder, etc.);\n* Receiving ABA of 15 hours or more;\n* Presence of active medical problem (e.g., unstable seizure disorder or heart disease);\n* Previous adequate Pivotal Response Treatment (PRT) trial;\n* Participants living more than 30 miles from Stanford University;\n* Child's primary language other than English.","2 Years","5 Years",{"count":127,"type":21},120,[24],"The aim of this clinical trial is to compare the efficacy of a 16-week center-based Pivotal Response Treatment (PRT-C) versus home-based Pivotal Response Treatment (PRT-H) in targeting social communication deficits in young children with autism spectrum disorder (ASD) with significant language delay. The two groups will also be compared to a control group that consists of children who are receiving treatment as usual (TAU).",[103,29,35],[132,133,134,135],"pivotal response treatment","PRT","center based","social and communication",{"date":77,"type":42},{"date":138,"type":42},"2022-10-18",{"date":140,"type":21},"2028-09-15",{"name":114,"class":115},{"id":143,"slug":144,"hasResults":12,"nctId":145,"briefTitle":146,"officialTitle":146,"acronym":4,"eligibilityCriteria":147,"healthyVolunteers":12,"sex":17,"minAge":124,"maxAge":125,"enrollmentInfo":148,"targetDuration":4,"studyType":22,"phases":150,"briefSummary":151,"conditions":152,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":156,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":50},"100364526","a-center-based-early-intervention-program-for-preschoolers-with-developmental-disorders-100364526","NCT04026386","A Center Based Early Intervention Program For Preschoolers With Developmental Disorders","Inclusion Criteria:\n\n* Diagnosis of Developmental Disorder, such as Autism Spectrum Disorder, neurogenetic disorder, or intellectual disability, based on clinical interview;\n* Boys and girls between 2.0 years and 5.11 years at time of enrollment;\n* Ability to participate in the testing procedures to the extent that valid standard scores can be obtained.\n\nExclusion Criteria:\n\n* Current or lifetime diagnosis of severe psychiatric disorder (e.g., bipolar disorder, etc.);\n* Lack of availability during program hours.",{"count":149,"type":21},75,[24],"The purpose of this study is to examine the effectiveness of a 12-week early intervention program that will include 12 weekly hours in an intensive center-based preschool environment or in the home to treat social communication deficits in children with developmental disorders. The study will include children with developmental disorders, such as Autism Spectrum Disorder, neurogenetic disorders, or intellectual disability.",[153,154,155,29],"Development Disorder, Child","Developmental Disability","Development Delay",{"date":79,"type":42},{"date":158,"type":42},"2019-10-19",{"date":160,"type":21},"2034-12-30",{"name":114,"class":115},{"id":163,"slug":164,"hasResults":12,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":4,"eligibilityCriteria":168,"healthyVolunteers":12,"sex":17,"minAge":124,"maxAge":58,"enrollmentInfo":169,"targetDuration":4,"studyType":22,"phases":170,"briefSummary":172,"conditions":173,"keywords":174,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":176,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":50},"100352269","phase-2-a-study-of-esomeprazole-in-children-with-autism-100352269","NCT03866668","A Study of Esomeprazole in Children With Autism","An Open-Label Pilot Study of Esomeprazole in Children With Autism","Inclusion Criteria:\n\n* outpatients 2 to 6 years of age;\n* males and females who are physically healthy;\n* diagnosis of autism spectrum disorder based on clinical evaluation and DSM-5 criteria, and confirmed using the Autism Diagnostic Interview-Revised, and the Autism Diagnostic Observation Schedule or Childhood Autism Rating Scale second edition (CARS-2)\n* care provider who could reliably bring subject to clinic visits, could provide trustworthy ratings, and interacted with subject on a regular basis;\n* ability of subject to swallow the compound;\n* stable concomitant medications for at least 2 weeks (4 weeks if patient took fluoxetine);\n* no planned changes in psychosocial interventions during the open-label trial.\n\nExclusion Criteria:\n\n* DSM-5 diagnosis of schizophrenia, schizoaffective disorder, or psychotic disorder not otherwise specified;\n* prior adequate trial of Esomeprazole;\n* active medical problems such as unstable seizures, or significant physical illness (e.g., serious liver or renal pathology).",{"count":7,"type":21},[171],"PHASE2","Autism is a pervasive developmental disorder characterized by core deficits in social behavior and communication and the presence of repetitive\u002Fstereotyped behaviors. The objective of the study is to evaluate the efficacy of Esomeprazole as a treatment for social communication deficits in children with Autism Spectrum Disorder (ASD). This prospective 12 week open-label study will invite 25 children with ASD between the ages of 2 and 6 years of age to participate.",[103,29],[175],"Esomeprazole",{"date":79,"type":42},{"date":178,"type":42},"2019-05-29",{"date":180,"type":21},"2028-12",{"name":114,"class":115},{"id":183,"slug":184,"hasResults":12,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":188,"eligibilityCriteria":189,"healthyVolunteers":94,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":190,"targetDuration":4,"studyType":62,"phases":4,"briefSummary":192,"conditions":193,"keywords":195,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":50},"100491653","platform-for-the-prospective-mother-child-study-of-the-determinants-of-neurodevelopmental-disorders-100491653","NCT05681923","Platform for the Prospective Mother-child Study of the Determinants of Neurodevelopmental Disorders","Platform for the Prospective Mother-child Study of the Determinants of Autism Spectrum Disorder and Neurodevelopmental Disorders Neurodevelopmental Disorders","MARIANNE","INCLUSION CRITERIA:\n\nGeneral inclusion criteria (High risk and Low risk cohorts)\n\nMother:\n\n* Be pregnant (single or multiple pregnancy), at least 16 weeks of amenorrhea,\n* Have at least one biological child of 24 months or older,\n* At least 18 years of age\n\nFather:\n\n* Be the biological father of the unborn child,\n* At least 18 years of age\n\nUnborn Child:\n\n\\- Have a woman study participant as mother.\n\nSpecific inclusion criteria for the High risk cohort:\n\n* Autistic sibling: refers to the biological child(ren) of the mother and\u002For father participating in the study and being the parent(s) of the unborn child\n* Be at least 24 months old and less than 18 years old,\n* Have a confirmed diagnosis of Autism Spectrum Disorder based on medical records. If in doubt, the SRS-2 (Social Responsiveness Scale for Adults) and PEDS-DM (Parents' Evaluation of developmental status) questionnaires will be completed. Only children with positive scores on one of these questionnaires will be included after validation of the diagnosis by an expert committee,\n* In case of several children with Autism Spectrum Disorder based in the siblings, only the last born will be included.\n\nRemarks:\n\n* Autism Spectrum Disorder siblings resulting from a medically assisted procreation are eligible provided that part of the genetic heritage is common to that of the mother or father of the unborn child participating in the study.\n* If the father does not live with the mother of the unborn child, his participation is not required and does not preclude the participation of other family members.\n\nEXCLUSION CRITERIA:\n\nGeneral non-inclusion criteria (High risk and Low risk cohorts):\n\nFather and mother:\n\n* Unable to understand French or the study questionnaires\n* Participant on protective measures (guardianship or curatorship) or deprived of liberty by judicial or administrative decision, or subject to a legal protection measure\n* Not affiliated to a social security system\n* Refusal to participate. In the case of consent given for the born and unborn child, the consent must be given by the person(s) with parental authority.\n* Live at a distance from the recruitment center incompatible with follow-up.\n\nSpecific non-inclusion criteria for the Low risk cohort:\n\nMother and\u002For father of unborn child:\n\n\\- Have a biological child with a diagnosis of Autism Spectrum Disorder or other neuro developmental disorder",{"count":191,"type":21},7320,"Neurodevelopmental disorders such as attention deficit disorder with or without hyperactivity, autism spectrum disorder, language and social communication disorder, motor coordination disorder, learning disorder (dyslexia, dyscalculia, dysorthography), intellectual development disorder are frequent and long-lasting developmental difficulties that can be observed in children in various domains. They are often associated and have a significant impact on daily functioning at school and at home.\n\nThe rate of people affected by neurodevelopmental disorders including autism spectrum disorder have increased significantly over the past 20 years. Improved screening only partly explains this evolution.\n\nA genetic predisposition plays an important role in the occurrence of these disorders, however, current scientific data suggest a multifactorial origin. Exposures such as those related to the use of pesticides, air pollution or the presence of endocrine disruptors in our diet could be involved in the genesis of neurodevelopmental disorders, particularly during intrauterine life, a period of great vulnerability.\n\nThe current diagnostic pathways for autism rarely enable the early identification of babies at risk. Without early detection and timely targeted intervention, these children have a poor health outcome and do not reach their full potential.\n\nThe general objective of the MARIANNE cohort is to constitute a French research infrastructure dedicated to research on the biological and environmental determinants of neurodevelopmental disorders including autism.\n\nThis cohort is based on the follow-up of 1200 families with already a child affected by an autism spectrum disorder, which implies a high risk of neurodevelopmental disorders including autism spectrum disorder for the siblings, and of 500 families from the general population with no excess risk of neurodevelopmental disorders. The total number of subjects to be included (mother, father, unborn child and ASD sibling for the HR group) is thus 6300.\n\nThe inclusion of these families will be at the beginning of a new pregnancy and the follow-up will be carried out from the second trimester of pregnancy until the children are 6 years old, the age at which the diagnosis of neurodevelopmental disorders is possible.\n\nBiological, clinical, social and environmental data will be collected at different stages of the follow-up and will be included into a large database.",[29,194],"Neurodevelopmental Disorders",[196,197,198,199,200],"exposome","child development","genome","risk factors","prenatal cohort","2026-06-18",{"date":107,"type":42},{"date":204,"type":42},"2023-04-19",{"date":206,"type":21},"2034-03",{"name":208,"class":115},"University Hospital, Montpellier",{"id":210,"slug":211,"hasResults":12,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":215,"eligibilityCriteria":216,"healthyVolunteers":12,"sex":17,"minAge":217,"maxAge":58,"enrollmentInfo":218,"targetDuration":4,"studyType":22,"phases":220,"briefSummary":221,"conditions":222,"keywords":223,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":50},"100641213","phase-2-a-placebo-controlled-trial-of-folinic-acid-in-children-with-asd-100641213","NCT07642661","A Placebo-controlled Trial of Folinic Acid in Children With ASD","A Placebo-Controlled, Randomized, Double-Blind Study to Assess the Safety, Tolerability and Efficacy of Folinic Acid Administered to Pediatric Subjects With Autism Spectrum Disorder (ASD)","AFAT","Inclusion Criteria:\n\n* Children aged 3 to 6 years.\n* Diagnosis of autism spectrum disorder (ASD) according to DSM-5 criteria.\n* ASD diagnosis confirmed by Autism Diagnostic Observation Schedule, Second Edition (ADOS-2).\n* ASD diagnosis made at least 6 months before screening.\n* Non-syndromic ASD, defined as ASD occurring in the absence of a known genetic syndrome, chromosomal abnormality, major congenital anomaly, or identifiable metabolic or neurological disorder.\n* CGI-S score ≥ 4.\n* ABC-I score ≥ 12.\n* SRS-2 total T-score ≥ 66.\n* Body weight between 11.45 kg and \\\u003C27 kg.\n\nExclusion Criteria:\n\n* A seizure or a change in antiepileptic medication within 8 weeks prior to randomization.\n* Clinically significant abnormalities on physical examination or laboratory testing, including significant impairment of cardiac, hepatic, or renal function.\n* Treatment with folinic acid within 3 months prior to randomization.\n* Any change in pharmacological treatment, behavioral treatment, home environment, or school setting (other than school holidays) within 4 weeks prior to randomization, or planned changes during study participation.\n* Predicted inability or unwillingness to comply with study procedures.\n* Use of antifolate medications or other agents known to interfere with folate metabolism (e.g., methotrexate, trimethoprim).","3 Years",{"count":219,"type":21},150,[171],"Autism spectrum disorder (ASD) is a neurodevelopmental condition characterized by difficulties in social communication and the presence of restricted or repetitive behaviors. Although behavioral and educational interventions can be helpful, there is currently no established medication for the core symptoms of ASD. Medications approved for associated irritability may be effective in some children but are often associated with significant adverse effects.\n\nFolinic acid (also known as leucovorin) is a reduced form of folate that plays an important role in brain development, neurotransmitter production, DNA methylation, and cellular metabolism. Previous clinical studies have suggested that folinic acid may improve communication, social functioning, and behavioral symptoms in some children with ASD. However, existing studies have generally been small and have used different outcome measures, and the current evidence is insufficient to establish the efficacy and optimal dosing of folinic acid in ASD.\n\nThis multicenter, randomized, double-blind, placebo-controlled clinical trial is designed to evaluate the safety, tolerability, and efficacy of folinic acid in children with ASD. A total of 150 children aged 3 to 6 years with ASD and clinically significant behavioral symptoms will be enrolled at multiple sites in Israel. Participants will be randomly assigned in a 1:1 ratio to receive either folinic acid or matching placebo for 9 weeks in addition to their existing treatments.\n\nThe primary objective of the study is to determine whether folinic acid improves behavioral symptoms compared with placebo, as measured by the Aberrant Behavior Checklist Irritability Subscale (ABC-I). Secondary objectives include evaluating the effects of folinic acid on communication, socialization, adaptive functioning, autism symptoms, emotional regulation, disruptive behavior, sleep, gastrointestinal symptoms, caregiver quality of life, and overall clinical improvement.\n\nFollowing completion of the initial 9-week placebo-controlled phase, participants will enter a second 8-week double-blind treatment phase in which they will be randomly assigned to receive one of two folinic acid dose regimens. This phase is intended to explore whether different maintenance doses are associated with differences in clinical outcomes.\n\nThe study will also investigate potential biological markers associated with treatment response. Blood and stool samples will be collected to assess folate-related biomarkers, folate receptor alpha autoantibodies, oxidative stress markers, transcriptomic profiles, proteomic signatures, and gut microbiota composition. The study will also examine whether these biological measures are associated with symptom severity or response to treatment.\n\nThe results of this study are expected to provide important information regarding the efficacy, safety, and optimal use of folinic acid in children with ASD and may help identify biological factors associated with treatment response.",[29],[35,103,224,225,226,227,228],"Folinic Acid","Leucovorin","Calcium Folinate","placebo","Folate Receptor Alpha Autoantibodies","2026-06-17",{"date":107,"type":42},{"date":232,"type":21},"2026-06-23",{"date":234,"type":21},"2027-12-31",{"name":236,"class":115},"Prof. Adi Aran",{"id":238,"slug":239,"hasResults":12,"nctId":240,"briefTitle":241,"officialTitle":242,"acronym":243,"eligibilityCriteria":244,"healthyVolunteers":12,"sex":17,"minAge":124,"maxAge":125,"enrollmentInfo":245,"targetDuration":4,"studyType":22,"phases":247,"briefSummary":248,"conditions":249,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":250,"startDateStruct":251,"completionDateStruct":252,"leadSponsor":254,"locationsCount":50},"100569131","trial-of-an-online-spanish-pivotal-response-treatment-training-in-autism-spectrum-disorder-100569131","NCT06690255","Trial of an Online Spanish Pivotal Response Treatment Training in Autism Spectrum Disorder","Trial of an Online Spanish Pivotal Response Treatment Training in Autism Spectrum Disorder (PRT-OS)","PRT-OS","Inclusion Criteria:\n\n* Children aged 2 to 5 years, 11 months at the time of consent\n* Diagnosis of Autism Spectrum Disorder (ASD), confirmed through medical records and\u002For parent questionnaire\n* Significant language delay, indicated by scores 2 standard deviations (SD) below the average for ages 2 and 3, or 3 SD below the average for ages 4 and 5 on the Vineland-3 Communication subscale or Expressive V-scale\n* A Spanish-speaking parent or primary caregiver available to consistently participate in study activities and implement PRT in Spanish\n* Stable on any psychotropic medications or biomedical interventions for at least 1 month before baseline, with no anticipated changes during the study\n* Consistent treatment or intervention services (such as ABA, Floortime, or speech therapy) and stable school placement for at least 1 month before baseline, with no expected changes\n* Limited to no more than 60 minutes of one-on-one speech therapy per week\n\nExclusion Criteria:\n\n* Primary language of the child or parent is not Spanish\n* Either the child or parent has a severe psychiatric disorder or an unstable medical condition\n* Prior exposure to or adequate trial of Pivotal Response Treatment, resulting in the parent achieving fidelity in PRT implementation at baseline\n* The child is currently receiving more than 15 hours of one-on-one Applied Behavior Analysis (ABA) therapy per week",{"count":246,"type":21},40,[24],"The goal of this clinical trial is to understand if an online course in Spanish can help Spanish-speaking parents use Pivotal Response Treatment (PRT) to support language and social skills in young children with Autism Spectrum Disorder (ASD). This study aims to reach families who may have trouble accessing autism services due to language, location, or cost barriers. The main questions it hopes to answer are:\n\n* Can Spanish-speaking parents learn to effectively use PRT techniques to support their child's communication?\n* Does this training improve children's language and social interactions?\n\nResearchers will evaluate the effectiveness of the online course for parents who participate in regular virtual check-ins and submit videos showing their practice with PRT.\n\nParticipants in the study will:\n\n* Complete online lessons over 12 weeks that teach PRT methods, specifically designed for Spanish-speaking parents\n* Meet with a research team member every few weeks by phone or video to ask questions and receive feedback\n* Provide video recordings of interactions with their child to track progress\n* Complete brief surveys about their experience and child's communication abilities\n\nBy focusing on Spanish-speaking families, this study aims to increase access to effective autism support and reduce gaps in care. Researchers hope the findings will help develop better resources for families facing similar barriers and improve language and social outcomes for children with autism.",[29],{"date":107,"type":42},{"date":229,"type":42},{"date":253,"type":21},"2030-12-15",{"name":114,"class":115},{"id":256,"slug":257,"hasResults":12,"nctId":258,"briefTitle":259,"officialTitle":260,"acronym":4,"eligibilityCriteria":261,"healthyVolunteers":12,"sex":17,"minAge":95,"maxAge":262,"enrollmentInfo":263,"targetDuration":4,"studyType":22,"phases":265,"briefSummary":266,"conditions":267,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":268,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":50},"100531756","autism-research-project-with-non-invasive-near-infrared-light-stimulation-100531756","NCT06203938","Autism Research Project With Non-Invasive Near-Infrared Light Stimulation","Social and Behavioral Associations With Prefrontal Photobiomodulation in Autism Spectrum","Inclusion Criteria:\n\n* Age between 4-60 years\n\nExclusion Criteria:\n\n* Current pregnancy","60 Years",{"count":264,"type":21},280,[24],"The investigators have previously shown that the administration of low-level infrared light is a safe and non-invasive procedure which improves cognition and emotion, as well as enhances brain metabolic activity. Based on previous studies, the investigators hypothesize that this methodology, called low-level light therapy or photobiomodulation, could be used to improve behavioral symptoms in individuals with autism spectrum disorder (ASD).",[29],{"date":107,"type":42},{"date":270,"type":42},"2025-01-13",{"date":272,"type":21},"2027-12",{"name":274,"class":115},"Francisco Gonzalez-Lima, PhD",{"id":276,"slug":277,"hasResults":12,"nctId":278,"briefTitle":279,"officialTitle":279,"acronym":4,"eligibilityCriteria":280,"healthyVolunteers":12,"sex":17,"minAge":217,"maxAge":281,"enrollmentInfo":282,"targetDuration":4,"studyType":22,"phases":284,"briefSummary":286,"conditions":287,"keywords":289,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":306,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":311,"locationsCount":50},"100616348","phase-1-adia-med-of-winter-park-llc-autism-spectrum-disorder-research-study-100616348","NCT07304440","Adia MED of Winter Park LLC Autism Spectrum Disorder Research Study","Inclusion Criteria:\n\n* Age 3-12 years\n* Confirmed ASD diagnosis (DSM-5 criteria, supported by ADOS-2)\n* Parent\u002Fguardian willingness to consider experimental treatments and comply with study requirements\n* Ability to attend all scheduled visits\n* Able to meet study cost requirements ($12,000 study fee plus bloodwork costs, if applicable) as described in the informed consent\n\nExclusion Criteria:\n\n* Severe allergies to study products\n* Significant uncontrolled medical conditions\n* Pregnancy or breastfeeding (if applicable)\n* Participation in another interventional trial within 30 days\n* Prior stem cell or glutathione therapy: History of stem cell therapy (including umbilical cord blood-derived stem cells or exosomes) or glutathione therapy (intravenous or topical) at any time prior to screening","12 Years",{"count":283,"type":21},100,[285,171],"PHASE1","This 24-month study is testing whether adding AdiaVita, an umbilical cord blood-derived stem cell and exosome product, to glutathione therapy helps improve autism symptoms in children ages 3-12 more than glutathione alone. Children will be randomly placed into one of two groups for the first three months: one group receives glutathione only, and the other receives glutathione plus monthly intravenous AdiaVita infusions. Both groups also use topical glutathione cream twice daily at home. Autism symptoms will be tracked over two years using the Autism Treatment Evaluation Checklist (ATEC) filled out by parents and by therapists or teachers. Safety, side effects, quality of life, and overall well-being will be closely monitored through regular clinic visits, physical exams, blood tests, and adverse event reporting. After the initial three-month phase, children who received glutathione alone may cross over to receive AdiaVita infusions at no additional cost if safety checks at month 6 are satisfactory. Approximately 100 children with a confirmed autism diagnosis from the Central Florida area will take part. Participation is completely voluntary, and families may withdraw at any time.",[29,103,35,288],"Autism Spectrum Disorder (ASD)",[290,291,292,293,294,295,296,103,29,35,297,298,299,300,301,302,303,304],"Glutathione","Intravenous glutathione","Glutathione therapy","Antioxidant therapy","Oxidative stress","Immune modulation","Anti-inflammatory therapy","Autism symptoms","Stem cell therapy","MSCs","Mesenchymal stem cells","Regenerative medicine","Cellular therapy","Hematopoietic stem cells (HSCs)","Allogeneic stem cells","2026-06-16",{"date":229,"type":42},{"date":308,"type":42},"2026-05-01",{"date":310,"type":21},"2028-06-15",{"name":312,"class":115},"Adia Med of Winter Park LLC",{"id":314,"slug":315,"hasResults":12,"nctId":316,"briefTitle":317,"officialTitle":317,"acronym":318,"eligibilityCriteria":319,"healthyVolunteers":12,"sex":17,"minAge":95,"maxAge":281,"enrollmentInfo":320,"targetDuration":4,"studyType":22,"phases":322,"briefSummary":323,"conditions":324,"keywords":325,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":330,"startDateStruct":331,"completionDateStruct":333,"leadSponsor":335,"locationsCount":50},"100607863","effectiveness--implementation-trial-of-the-function-based-elopement-treatment-100607863","NCT07194083","Effectiveness- Implementation Trial of the Function-Based Elopement Treatment","(FBET)","Inclusion Criteria:\n\nChild participant:\n\n* Boys and girls ages \\> 4 to \\\u003C 12 years\n* Autism Spectrum Disorder (ASD) diagnosis by history\n* Presence of elopement as an important caregiver concern - elopement occurring regularly for at least 3 months.\n* At least one primary caregiver can speak and understand English.\n\nExclusion Criteria:\n\n• Non-English speaking participants",{"count":321,"type":21},50,[24],"The goal of this clinical trial is to test whether the Function-Based Elopement Treatment (FBET) can reduce elopement in children aged 4-12 with autism spectrum disorder (ASD), and to assess its feasibility in community-based Applied Behavior Analysis (ABA) clinics. Researchers will evaluate FBET in a single-arm open-label trial in one clinic, followed by a comparison of FBET to treatment as usual (TAU) across at least six ABA clinics to evaluate effectiveness and implementation.\n\nThe main questions it aims to answer are:\n\n* Is it feasible to use FBET in community-based ABA clinics?\n* Does FBET reduce elopement?\n* Does FBET lead to greater clinical improvement?\n\nParticipants will:\n\n* Receive 12 sessions of FBET over 20 weeks with trained BCBAs or receive treatment as usual\n* Complete caregiver assessments at baseline and endpoint\n* Engage in caregiver training and practice treatment between appointments",[29],[326,29,327,328,329],"Function Based Elopement Treatment","Applied Behavior Analysis","Elopement","Functional Analysis",{"date":201,"type":42},{"date":332,"type":42},"2026-03-30",{"date":334,"type":21},"2028-10",{"name":336,"class":115},"Emory University",{"id":338,"slug":339,"hasResults":12,"nctId":340,"briefTitle":341,"officialTitle":342,"acronym":4,"eligibilityCriteria":343,"healthyVolunteers":12,"sex":17,"minAge":95,"maxAge":344,"enrollmentInfo":345,"targetDuration":4,"studyType":22,"phases":347,"briefSummary":348,"conditions":349,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":350,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":355,"locationsCount":50},"100568178","exploring-the-gut-brain-behavior-axis-with-biomarkers-probiotic-efficacy-and-artificial-intelligence-algorithms-100568178","NCT06677840","Exploring the Gut-Brain-Behavior Axis With Biomarkers, Probiotic Efficacy, and Artificial Intelligence Algorithms","Precision Health in Autism: Exploring the Gut-Brain-Behavior Axis With Biomarkers, Probiotic Efficacy, and Artificial Intelligence Algorithms","Inclusion Criteria:\n\n* Children and adolescents aged 4 to 15 who are clinically diagnosed with ASD according to DSM-5 criteria and confirmed by the ADI-R\u002FADOS.\n* Caregivers cooperate with all the assessments and stool and blood collection.\n\nExclusion Criteria:\n\n* A history of major psychiatric disorders (e.g., schizophrenia, bipolar disorder, major depression), neurological disorders, and substances use disorders.\n* Difficulty following instructions.\n* Consumption of antibiotics and yogurt or probiotic products two weeks prior to enrollment.","15 Years",{"count":346,"type":21},110,[24],"This groundbreaking human study on the ASD microbiome includes probiotic clinical trials, investigation of treatment biomarkers, machine learning\u002Fdeep learning platform development for ASD classification and prediction, and identification of diagnostic biomarkers. Upon completion, the investigators anticipate publishing at least 12 SCI papers and\u002For patents and establishing an auxiliary diagnosis platform for both clinical and academic purposes. The findings will offer new insights into the pathogenetic mechanisms, improving early detection, diagnosis, and treatment, ultimately advancing precision medicine for ASD.",[29],{"date":201,"type":42},{"date":352,"type":42},"2024-05-01",{"date":354,"type":21},"2028-04-30",{"name":356,"class":115},"National Taiwan University Hospital",{"id":358,"slug":359,"hasResults":12,"nctId":360,"briefTitle":361,"officialTitle":362,"acronym":4,"eligibilityCriteria":363,"healthyVolunteers":12,"sex":17,"minAge":58,"maxAge":364,"enrollmentInfo":365,"targetDuration":4,"studyType":22,"phases":367,"briefSummary":368,"conditions":369,"keywords":371,"overallStatus":377,"whyStopped":4,"lastUpdateSubmitDate":378,"lastUpdatePostDateStruct":379,"startDateStruct":380,"completionDateStruct":382,"leadSponsor":384,"locationsCount":50},"100641619","using-apollo-neuro-in-autistic-children-with-self-injurious-behavior-100641619","NCT07648420","Using Apollo Neuro in Autistic Children With Self-Injurious Behavior","Feasibility and Usability of the Apollo Neuro, a Wearable Sensory Device, in Autistic Children With Self-Injurious Behavior","Inclusion Criteria for child:\n\n* Diagnosis of autism spectrum disorder (ASD), as reported by caregiver\n* Presence of self-injurious behavior, as reported by caregiver\n* Demonstrates sensory over and\u002For under- responsivity\n* Aged 6 years to 14 years, 11 months (179 months) at the time of enrollment\n* Has a caregiver willing and able to provide consent and participate in study procedures\n\nExclusion Criteria for child:\n\n* Has medical condition that may increase risk with use of a wearable nibrotactile device, including:\n\n  * implanted medical or neurological devices (e.g., pacemaker)\n  * significant cardiac conditions or arrhythmias\n  * history of syncope (fainting)\n* Known seizure disorder without physician clearance\n* Regular use of nibrotactile or autonomic- modulating wearable devices within the past 90 days\n* Any condition that, in the judgment of the investigator, would interfere with safe participation or interpretation of study procedures\n\nInclusion Criteria for Caregiver:\n\n* Parent or legal guardian of the enrolled child participant\n* Able to provide informed consent in English\n* Able and willing to support device use according to study protocol and complete study-related data collection\n* Has access to a smartphone or compatible device capable of operating the Apollo Neuro application for the duration of study period\n\nExclusion Criteria for Caregiver:\n\n• Unable to provide informed consent in English","179 Months",{"count":366,"type":21},18,[24],"This study will evaluate the feasibility and acceptability of the Apollo Neuro, a wearable vibrotactile sensory device, in autistic children who engage in self-injurious behavior (SIB).\n\nParticipants will wear the device for at least 3 hours per day over a 30-35 day period with caregiver support. Outcomes will include adherence to device use, caregiver-reported feasibility and acceptability, and descriptive characterization of caregiver-reported self- injurious and repetitive behaviors during the study period. This preliminary, single-group study is not designed to evaluate efficacy and will inform the design of future controlled trials.",[370,29],"Self-Injurious Behavior",[372,373,374,375,376],"Apollo Neuro Device","Sensory Responsivity","Autonomic Regulation","Wearable Device","Vibrotactile Stimulation","NOT_YET_RECRUITING","2026-06-15",{"date":229,"type":42},{"date":381,"type":21},"2026-07",{"date":383,"type":21},"2026-11",{"name":385,"class":115},"Virginia Commonwealth University",{"id":387,"slug":388,"hasResults":12,"nctId":389,"briefTitle":390,"officialTitle":391,"acronym":392,"eligibilityCriteria":393,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":394,"enrollmentInfo":395,"targetDuration":4,"studyType":22,"phases":397,"briefSummary":398,"conditions":399,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":400,"lastUpdatePostDateStruct":401,"startDateStruct":402,"completionDateStruct":403,"leadSponsor":405,"locationsCount":50},"100642915","investigating-autimia-a-digital-intervention-for-patients-with-autism-spectrum-disorder-100642915","NCT07638657","Investigating Autimia, a Digital Intervention for Patients With Autism Spectrum Disorder","Investigating Autimia, a Digital Intervention for Patients With Autism Spectrum Disorder: Randomized Controlled Trial (Alnico Trial)","alnico","Inclusion Criteria:\n\n* prior suspected diagnosis of ASD by a healthcare professional\n* diagnosis of ASD (ICD-10 codes: F84.5, F84.0, F84.1) confirmed in a semi-structured diagnostic interview conducted as a telemedical consultation\n* IQ ≥ 80\n* increased levels of psychological distress (DASS-21 total score ≥ 21)\n* stable treatment (medication, psychotherapy, no treatment, …) for at least 30 days at the time of inclusion\n* sufficient knowledge of the German language\n* basic IT skills required for independent use of a digital intervention\n* consent to participation\n\nExclusion Criteria:\n\n* plans to change treatment (medication, psychotherapy, …) in the upcoming 3 months after inclusion\n* diagnosis of another severe psychiatric disorder (acute severe affective disorder, acute psychotic disorder, acute substance use disorder, borderline personality disorder, antisocial personality disorder)\n* acute suicidality\n* currently being under legal guardianship for healthcare decisions","65 Years",{"count":396,"type":21},236,[24],"The goal of this clinical trial is to find out if autimia, a digital health intervention, can help adults with ASD (Autism Spectrum Disorder) manage their daily lives and improve their well-being.\n\nThe main questions it aims to answer are:\n\n* Does autimia, together with regular treatment, improve health outcomes after three months better than regular treatment alone?\n* Are the positive effects of autimia still noticeable after six months?\n\nResearchers will compare two groups:\n\n* Intervention group: Participants use the autimia intervention and continue their usual treatment.\n* Control group: Participants continue with their usual treatment only.\n\nParticipants will:\n\n* Participate in a video call with a specialist to confirm a diagnosis of ASD\n* Fill out questionnaires online at the start of the study, after 3 months, and after 6 months\n* Continue with their usual treatment (both groups) and use autimia, a digital health intervention, for six months (intervention group only)",[29],"2026-06-12",{"date":305,"type":42},{"date":400,"type":42},{"date":404,"type":21},"2027-06",{"name":406,"class":407},"Gaia AG","INDUSTRY",{"id":409,"slug":410,"hasResults":12,"nctId":411,"briefTitle":412,"officialTitle":413,"acronym":414,"eligibilityCriteria":415,"healthyVolunteers":12,"sex":17,"minAge":217,"maxAge":281,"enrollmentInfo":416,"targetDuration":4,"studyType":62,"phases":4,"briefSummary":418,"conditions":419,"keywords":420,"overallStatus":377,"whyStopped":4,"lastUpdateSubmitDate":400,"lastUpdatePostDateStruct":425,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":430,"locationsCount":50},"100641728","gut-microbiome-characteristics-and-neurodevelopmental-functioning-in-children-with-autism-spectrum-disorder-100641728","NCT07646808","Gut Microbiome Characteristics and Neurodevelopmental Functioning in Children With Autism Spectrum Disorder","Association Between Gut Microbiome Characteristics and Neurodevelopmental Functioning in Children With Autism Spectrum Disorder: A Multidomain Investigation of the Gut-Motor Axis","GAIN-ASD","Inclusion Criteria:\n\n* Children aged 3 to 12 years\n* Clinical diagnosis of Autism Spectrum Disorder (ASD) according to DSM-5\u002FICD criteria and confirmed from medical records or specialist assessment\n* Stable clinical status at the time of enrollment\n* Parent\u002Flegal guardian willing to provide written informed consent\n* Child able to undergo stool sample collection and neurodevelopmental assessments\n* Parent\u002Fcaregiver able to complete questionnaires and provide dietary and medical history\n\nExclusion Criteria:\n\n* Use of systemic antibiotics, probiotics, prebiotics, synbiotics, or bowel-cleansing agents within the previous 4-12 weeks before stool collection\n* Presence of acute gastrointestinal infection or acute febrile illness at the time of assessment\n* Known chronic gastrointestinal disorders that may independently alter the gut microbiome, such as inflammatory bowel disease, celiac disease, short bowel syndrome, or chronic intestinal malabsorption\n* Major neurological, genetic, or metabolic disorders other than ASD that may independently affect neurodevelopment\n* Current use of medications known to significantly affect gut microbiota or bowel motility, if clinically relevant to your protocol\n* Inability to provide stool sample or complete the required assessments\n* Refusal of consent by parent\u002Flegal guardian",{"count":417,"type":21},600,"Autism Spectrum Disorder (ASD) is a neurodevelopmental condition that affects communication, behavior, sensory processing, and daily functioning. Recent research suggests that the gut microbiome, the community of microorganisms living in the gastrointestinal tract, may influence brain development and function through the gut-brain and gut-motor axes. Alterations in gut microbiome characteristics have been reported in children with ASD and may be associated with differences in neurodevelopmental outcomes.\n\nThis observational study aims to investigate the association between gut microbiome characteristics and neurodevelopmental functioning in children with ASD. The study will evaluate multiple domains of functioning, including motor performance, sensory processing, behavior, cognition, sleep, and participation in daily activities. Gut microbiome characteristics will be assessed using stool sample analysis, and neurodevelopmental outcomes will be measured using standardized assessments and validated questionnaires.\n\nThe findings of this study may improve understanding of the relationship between the gut microbiome and neurodevelopmental functioning in children with ASD and provide insights into the role of the gut-motor axis in shaping functional outcomes. This knowledge may support future research and contribute to the development of more personalized approaches to assessment and rehabilitation in ASD.",[29],[29,421,422,423,424],"Gut Microbiome","Gut-Brain Axis","Gut-Motor Axis","Motor Performance",{"date":305,"type":42},{"date":427,"type":21},"2026-07-01",{"date":429,"type":21},"2026-12-31",{"name":431,"class":115},"Saveetha University",{"id":433,"slug":434,"hasResults":12,"nctId":435,"briefTitle":436,"officialTitle":437,"acronym":438,"eligibilityCriteria":439,"healthyVolunteers":94,"sex":17,"minAge":18,"maxAge":440,"enrollmentInfo":441,"targetDuration":4,"studyType":22,"phases":442,"briefSummary":443,"conditions":444,"keywords":446,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":452,"lastUpdatePostDateStruct":453,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":458,"locationsCount":50},"100554348","rtms-to-improve-motor-function-in-autism-100554348","NCT06497920","rTMS to Improve Motor Function in Autism","Modulating Plasticity in the Motor Cortex Using Repetitive Transcranial Magnetic Stimulation to Improve Motor Function in Autism Spectrum Disorder","(AMBLE Autism)","Inclusion Criteria:\n\nASD or control participants must meet all of the inclusion criteria to eligible for this study:\n\n1. Aged between 18 and 40 years old. 40 years is chosen as the cut-off because of the report of high rates of Parkinsonism in autistic adults \\> 39years;\n2. Have IQ\\>70;\n3. Are able to read, write and communicate effectively in English;\n4. Are able to provide informed consent. We will recruit only intellectually-able autistic adults. The intellectual ability will be determined using WASI-II. The ability to provide consent will be determined using clinical assessment.\n5. Have no prior history of seizure;\n6. Must sign and date the informed consent form;\n7. Stated willingness to comply with all study procedures;\n8. Agreement to adhere to Lifestyle Considerations, that is: refrain from consumption of alcohol, tobacco, marijuana, or caffeine on the day of study visits.\n\nAll ASD participants:\n\n1. Will have DSM-5 diagnosis of ASD without intellectual disability, confirmed by clinical assessment and the Autism Diagnostic Observation Schedule - 2 (ADOS-2);\n2. Will have significant motor function difficulties defined as a standard composite score \\\u003C40 (i.e., \\>1 standard deviation below the mean) on either fine or gross motor composite scores of the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition or BOT-2;\n3. Are clinically stable as determined by clinical assessment, with no medication changes over the past 4 weeks. Given the high variability of handedness in ASD, we will include participants with left, right or mixed handedness.\n\nExclusion Criteria:\n\nASD or control participants will be excluded if they experience\u002Fhave:\n\n1. Current pregnancy;\n2. Current or past history of co-morbid medical condition that may require urgent medical intervention;\n3. DSM-5 substance use disorder (other than tobacco) within the past 6 months; however, all participants will be asked to refrain from smoking or taking caffeine four hours prior to the iTBS session;\n4. Significant hearing or visual impairment interfering with the ability to read or hear instructions;\n5. Significantly debilitating medical or neurologic illness (e.g., encephalitis, aneurysms, tumors, central nervous system infections), or acute or unstable medical illnesses as determined by project physician (e.g., uncontrolled diabetes);\n6. Metal implants or a pace-maker;\n7. Prior rTMS treatment;\n\nIn addition, ASD participants will be excluded if they report taking benzodiazepines or anticonvulsants currently.\n\nNT controls will be excluded if they have:\n\n1. Presence of psychopathology other than specific phobia, as screened by Personality Assessment Inventory and;\n2. A known diagnosis of Pervasive Developmental Disorder or ASD among any biologically related family members.","40 Years",{"count":219,"type":21},[24],"In the current project, investigators have two main goals: i) Testing whether an excessive plasticity, i.e. hyperplasticity in the motor cortex underlies motor function difficulties in autistic adults, and ii) Using repetitive Transcranial Magnetic Stimulation (rTMS) with autistic adults to examine whether resulting reduced hyperplasticity in the motor cortex will be associated with clinical improvements in the motor function.",[29,445],"Motor Activity",[103,447,448,449,450,451],"Motor Function","Repetitive Transcranial Magnetic Stimulation","Transcranial Magnetic Stimulation","Motor Cortex","Electroencephalography","2026-06-11",{"date":378,"type":42},{"date":455,"type":42},"2024-04-24",{"date":457,"type":21},"2029-06-30",{"name":459,"class":115},"Centre for Addiction and Mental Health",{"id":461,"slug":462,"hasResults":12,"nctId":463,"briefTitle":464,"officialTitle":465,"acronym":466,"eligibilityCriteria":467,"healthyVolunteers":12,"sex":17,"minAge":468,"maxAge":95,"enrollmentInfo":469,"targetDuration":4,"studyType":22,"phases":471,"briefSummary":472,"conditions":473,"keywords":474,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":452,"lastUpdatePostDateStruct":489,"startDateStruct":490,"completionDateStruct":492,"leadSponsor":494,"locationsCount":50},"100493651","how-simplified-language-affects-comprehension-and-learning-in-young-autistic-children-100493651","NCT05707923","How Simplified Language Affects Comprehension and Learning in Young Autistic Children","How Single-Word and Telegraphic Simplification Affects Language Processing and Word Learning in Young Children With Autism Spectrum Disorder","PALS","Inclusion Criteria:\n\n* Existing or suspected autism spectrum disorder, confirmed through ADOS-2\n* English as primary language\n* 1-4 years old\n\nExclusion Criteria:\n\n* Known genetic condition (e.g., Down syndrome, fragile X)\n* Cerebral palsy\n* Acquired brain injury\n* Uncorrected vision or hearing impairment","1 Year",{"count":470,"type":21},104,[24],"The long-term study goal is to experimentally evaluate the components (and likely active ingredients) of early language interventions for young children with ASD. The overall objective is to determine how single-word and telegraphic simplification affects real-time language processing and word learning in young children with ASD (relative to full, grammatical utterances). The proposed project will investigate three specific aims: 1) Determine how single-word and telegraphic simplification affects language processing. 2) Determine how single-word and telegraphic simplification affects word learning. 3) Evaluate child characteristics that may moderate the effects of linguistic simplification on language processing and word learning. Aim 1 will test the hypothesis that children with ASD will process full, grammatical utterances faster and more accurately than single-word or telegraphic utterances. Aim 2 will test the hypothesis that full, grammatical utterances will support word learning better than telegraphic or single-word utterances. Aim 3 will test the hypothesis that language and cognitive skills significantly moderate the effects of linguistic simplification on language processing and word learning in young children with ASD.",[29],[475,476,477,478,479,480,481,482,483,484,485,486,487,488],"language","autism","intervention","processing","learning","early childhood","treatment","early intervention","telegraphic","language input","looking-while-listening","eye tracking","comprehension","neurodevelopmental disorders",{"date":378,"type":42},{"date":491,"type":42},"2023-06-01",{"date":493,"type":21},"2027-05-31",{"name":495,"class":115},"Michigan State University",{"id":497,"slug":498,"hasResults":12,"nctId":499,"briefTitle":500,"officialTitle":500,"acronym":501,"eligibilityCriteria":502,"healthyVolunteers":12,"sex":17,"minAge":503,"maxAge":504,"enrollmentInfo":505,"targetDuration":4,"studyType":22,"phases":506,"briefSummary":507,"conditions":508,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":509,"lastUpdatePostDateStruct":510,"startDateStruct":511,"completionDateStruct":513,"leadSponsor":515,"locationsCount":517},"100452418","use-of-immersive-virtual-reality-to-train-the-multisensory-processing-capacities-of-children-aged-8-to-16-years-old-with-an-autism-spectrum-disorder-single-center-randomized-pilot-study-in-parallel-groups---sevire-sensory-virtual-reality-100452418","NCT05171244","Use of Immersive Virtual Reality to Train the Multisensory Processing Capacities of Children Aged 8 to 16 Years-old With an Autism Spectrum Disorder: Single-center Randomized Pilot Study in Parallel Groups - SEVIRE. (Sensory Virtual Reality)","SEVIRE","Inclusion Criteria:\n\n* Child \u002F adolescent aged 8 to 16 years, diagnosed with ASD (DSM-5, ADOS, ADI-R criteria).\n* Without intellectual delay (QNV\\> 70, WISC-IV or V, WAIS-III or IV).\n* Benefiting from a treatment program at the University Center for Child Psychiatry (CHRU Bretonneau-Tours).\n* Schooled in the ordinary school context (primary school, middle school, high school, ULIS).\n* Having expressed their agreement to participate in the study.\n\n  * Whose parents or legal representatives have signed written consent.\n  * Whose parents or legal representatives are affiliated or beneficiaries of a social security scheme.\n\nExclusion Criteria:\n\n* Neuromotor disorders.\n* Uncorrected visual disorders.\n* Hearing impairment.\n* Known epilepsy.\n* Anxiety syndromes identified.\n* Hyper ADD \u002F H type activity.\n* Treatment with methylphenidate. - Rare genetic syndrome.","8 Years","16 Years",{"count":321,"type":21},[24],"Autism Spectrum Disorder (ASD) is defined as a neurodevelopmental disorder that affects the functioning and development of social communication (DSM5 - 2013). ASD causes particularities in sensory treatments (auditory, visual), qualified as uni-modal. Added to this, there is difficulties to deal with prevailing stimuli of the environment (pluri-modal) ; parents report the discomfort of their child in this situation with \"noisy\" behavioral manifestations. Therapeutic social skills programs most often address the subject's lack of adjustment to their environment through understanding social rules and codes and cognitive treatment of situations.\n\nThus, in order to relieve the sensory modulation disorders which can be the cause of social adjustment difficulties, it's propose to exercise the sensory habituation of children with ASD thanks to virtual reality scenarios restored in 3D immersion booth (the CAVE). The child will be exposed to multimodal stimulation during immersion sessions reproducing the conditions of an ecological environment. A therapist will accompany the child in the CAVE throughout the session.\n\nThe investigators hypothesize that regular and repeated exposure to a simulated environment in the CAVE can improve multisensory treatment capacities and have a beneficial effect on the autonomy of children and adolescents with ASD in everyday situations.",[29],"2026-06-10",{"date":452,"type":42},{"date":512,"type":42},"2022-03-03",{"date":514,"type":21},"2028-08",{"name":516,"class":115},"University Hospital, Tours",2,{"id":519,"slug":520,"hasResults":12,"nctId":521,"briefTitle":522,"officialTitle":523,"acronym":4,"eligibilityCriteria":524,"healthyVolunteers":12,"sex":17,"minAge":95,"maxAge":58,"enrollmentInfo":525,"targetDuration":4,"studyType":22,"phases":527,"briefSummary":528,"conditions":529,"keywords":530,"overallStatus":377,"whyStopped":4,"lastUpdateSubmitDate":538,"lastUpdatePostDateStruct":539,"startDateStruct":540,"completionDateStruct":542,"leadSponsor":544,"locationsCount":50},"100642616","cognitive-training-in-virtual-reality-for-autism-100642616","NCT07643649","Cognitive Training in Virtual Reality for Autism","Mind in Motion: Assessing the Efficacy of Virtual Reality Cognitive Training in Neurodivergent Children With Autism","Inclusion Criteria:\n\n* Diagnosis of Autism\n* QI \\> 70\n\nExclusion Criteria:\n\n* Severe neurological or sensory comorbidities",{"count":526,"type":21},30,[24],"The Virtual Reality Rehabilitation System (VRRS) is an innovative tool for motor and cognitive rehabilitation that has shown promising results in developmental populations, with evidence of feasibility, safety, acceptability, and positive effects on attention, executive functions, and learning-related processes. Its playful and motivating features, together with the possibility of tailoring task difficulty and delivering intensive training in a controlled environment, make VRRS a promising intervention for children with autism spectrum disorder (ASD), who frequently present weaknesses in visual attention, executive functioning, and visuospatial memory.\n\nThis randomized controlled trial aims to evaluate the efficacy of a VRRS-based cognitive training program in improving visual attention, executive functions, and visuospatial memory in children with ASD, compared with an active control intervention based on conventional cognitive training. Children aged 4 to 6 years 11 months with ASD, non-verbal IQ \\>70, and no severe neurological or sensory comorbidities will be enrolled and randomly assigned to the experimental or control group. The intervention will consist of two 45-minute sessions per week for 12 weeks. VRRS training will include individualized tasks targeting the selected cognitive domains, with adjustable difficulty, execution time, and repetitions. Assessments will be conducted at baseline (T0) and post-intervention (T1). At baseline, non-verbal cognitive functioning will be assessed using Leiter International Performance Scale, Third Edition (LEITER-3), while attention, executive functions, and visuospatial memory will be measured using Preschool Executive Functions Assessment Battery (FE-PS), LEITER-3 attention and memory tasks, Developmental Neuropsychological Assessment - Second Edition (NEPSY-II) (Memory for Designs), and Behavior rating inventory of executive function-preschool version (BRIEF-P). The same battery will be repeated after training to compare pre- and post-intervention scores and estimate the relative efficacy of the two approaches.\n\nIt is hypothesized that children receiving VRRS-based training will show greater improvements in the targeted cognitive functions than those receiving conventional training, supporting the clinical utility of virtual reality as an effective and engaging rehabilitation approach for children with ASD.",[103,29],[476,531,532,533,534,535,536,29,537],"children","Virtual Reality Rehabilitation System","Cognitive Training","Executive Functions","Visual Attention","Visuo-Spatial Memory","Autism Spectrum Condition","2026-06-09",{"date":452,"type":42},{"date":541,"type":21},"2026-09-01",{"date":543,"type":21},"2027-03-31",{"name":545,"class":115},"Istituto per la Ricerca e l'Innovazione Biomedica",{"id":547,"slug":548,"hasResults":12,"nctId":549,"briefTitle":550,"officialTitle":551,"acronym":4,"eligibilityCriteria":552,"healthyVolunteers":12,"sex":17,"minAge":553,"maxAge":554,"enrollmentInfo":555,"targetDuration":4,"studyType":22,"phases":557,"briefSummary":558,"conditions":559,"keywords":560,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":564,"lastUpdatePostDateStruct":565,"startDateStruct":566,"completionDateStruct":568,"leadSponsor":570,"locationsCount":50},"100471516","early-diagnostic-response-model-edrm-100471516","NCT05419895","Early Diagnostic Response Model (EDRM)","Early Diagnostic Response Model (EDRM): Evaluating an Early Screening to Evaluation Pilot Protocol for Children Identified as High Risk for Autism in Early Intervention Health Districts","Inclusion Criteria:\n\n* All families of children between the ages of 16-30 months of age who scored ≥8 on the MCHAT-R and whose BCW provider refers the child to our clinic by 33 months of age will be a possible participant. Evaluations will be done by 36 months of age.\n* Referring BCW provider must be one of the participating BCW health districts in this pilot study.\n* Parent\u002FGuardian needs to have basic English proficiency\n* Parent\u002FGuardian needs to have internet access\n* Child must have exposure to English either at home or in out-of-home care (e.g., childcare setting).\n* Documentation of M-CHAT-R High-Risk failed score (≥ 8) must be documented in referral.\n\nExclusion Criteria:\n\n* Families making self-referrals to the EAC or referrals outside of the targeted BCW districts will be excluded from recruitment for this study.\n* Children above the age of 33 months at the time of the referral will be excluded as the current EDRM protocol has not been developed in this phase of piloting for individuals over this age.\n* Non-English speakers will be excluded from participation due to the current protocol not being applicable to their needs as well as a high correlation between verbal language abilities and social communication and social interaction (SCI) abilities as part of the DSM-5-TR autism criteria.","16 Months","36 Months",{"count":556,"type":21},300,[24],"Babies Can't Wait (BCW) in Georgia will be referring families with children seeking an autism spectrum disorder (autism) diagnosis at the Emory Autism Center's (EAC) Child Screening and Assessment Clinic.The objective of this study is to develop, pilot, and evaluate a diagnostic protocol for children identified at high risk for autism in the BCW early intervention program screening (part of a public health service). This program evaluation will be using pre- and post-data and data collected through the process to evaluate the effectiveness of the EDRM pilot.",[29,103],[103,561,562,563],"Early Intervention","Telehealth","Assessment","2026-06-08",{"date":509,"type":42},{"date":567,"type":42},"2022-06-16",{"date":569,"type":21},"2028-07",{"name":336,"class":115},{"id":572,"slug":573,"hasResults":12,"nctId":574,"briefTitle":575,"officialTitle":576,"acronym":4,"eligibilityCriteria":577,"healthyVolunteers":12,"sex":17,"minAge":217,"maxAge":504,"enrollmentInfo":578,"targetDuration":4,"studyType":22,"phases":579,"briefSummary":580,"conditions":581,"keywords":582,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":585,"lastUpdatePostDateStruct":586,"startDateStruct":587,"completionDateStruct":589,"leadSponsor":591,"locationsCount":50},"100622265","fecal-microbiota-transplantation-in-children-with-asd-100622265","NCT07381374","Fecal Microbiota Transplantation in Children With ASD","Study Protocol for a Randomized Controlled of Fecal Microbiota Transplantation Via Different Routes in Children With Moderate-to-Severe Autism Spectrum Disorder","Inclusion Criteria:\n\n* Aged 3-16 years.\n* Diagnosed with ASD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), with a Childhood Autism Rating Scale (CARS) total score ≥36 (moderate-to-severe autism).\n* Legal guardians fully comprehend the trial's informed consent and voluntarily provide written consent.\n* Compliance with follow-up visits, examinations, and specimen collection.\n* No probiotic supplements consumed within the preceding 3 months.\n\nExclusion Criteria:\n\n* Use of probiotics or prebiotics within 3 months prior to enrollment.\n* Antibiotic usage within 1 month prior to enrollment.\n* Presence of fever (axillary temperature ≥37.5°C).\n* Dependency on tube feeding.\n* Severe gastrointestinal conditions requiring immediate intervention (e.g., life-threatening intestinal obstruction, perforation, hemorrhage, ulcerative colitis, Crohn's disease, celiac disease, or eosinophilic esophagitis).\n* Diagnosis of severe malnutrition, underweight status (BMI-for-age \\\u003C3rd percentile), or severe immunodeficiency disorders.\n* History of severe allergic reactions (e.g., anaphylaxis).\n* Monogenic disorders (e.g., Fragile X syndrome, Rett syndrome).\n* Comorbid psychiatric diagnoses, including depression, developmental speech\u002Flanguage disorders, intellectual disability, attention-deficit\u002Fhyperactivity disorder (ADHD), selective mutism, reactive attachment disorder, or childhood schizophrenia.",{"count":50,"type":21},[24],"This is a single-center, randomized, double-dummy, triple-blind, placebo-controlled, three-arm parallel-group superiority trial. The study aims to compare the efficacy and safety of Fecal Microbiota Transplantation (FMT) administered via two different invasive routes-nasojejunal tube (NJT) and colonoscopy-versus a placebo control in children aged 3-16 years with moderate-to-severe Autism Spectrum Disorder (ASD). A total of 75 participants will be randomized in a 1:1:1 ratio to receive either active FMT via NJT with sham colonoscopy, active FMT via colonoscopy with sham NJT, or placebo via both routes. All participants will continue their stable behavioral interventions throughout the study. The primary outcome is the change from baseline to Week 24 in the total score of the Childhood Autism Rating Scale (CARS). Secondary outcomes include changes in other behavioral and gastrointestinal symptom scores, gut microbiota profiling, and safety assessments over 48 weeks.",[29],[29,583,584,531],"Fecal Microbiota Transplantation","Microbiome","2026-06-06",{"date":538,"type":42},{"date":588,"type":42},"2026-03-21",{"date":590,"type":21},"2027-04-12",{"name":592,"class":49},"Shenzhen Children's Hospital",{"id":594,"slug":595,"hasResults":12,"nctId":596,"briefTitle":597,"officialTitle":597,"acronym":598,"eligibilityCriteria":599,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":600,"enrollmentInfo":601,"targetDuration":4,"studyType":22,"phases":603,"briefSummary":604,"conditions":605,"keywords":4,"overallStatus":377,"whyStopped":4,"lastUpdateSubmitDate":607,"lastUpdatePostDateStruct":608,"startDateStruct":609,"completionDateStruct":611,"leadSponsor":613,"locationsCount":517},"100617212","understanding-and-treating-severe-and-resistant-pathological-aggression-using-deep-brain-stimulation-to-treat-resistant-aggression-100617212","NCT07315685","Understanding and Treating Severe and Resistant Pathological Aggression: Using Deep Brain Stimulation to Treat Resistant Aggression","STAR","Inclusion Criteria:\n\n* Aged between 18 and 70 inclusive\n* Patients who have been in isolation in a secure psychiatric unit for at least 50% of the time over a period of more than 6 months prior to inclusion\n* A GAF score \\\u003C21\n* An ICAP score \\\u003C40\n* Other stable medical conditions\n* No contraindications to brain imaging (MRI and CT)\n* No contraindications to taking medication for travel (loxapine and diazepam)\n* No contraindications to surgery\n* Adult who has read and understood the information letter and signed the consent form. A psychiatrist, independent of the study and treatment, will examine the patient and determine their ability to read and understand the consent form before signing. If this is not the case, authorisation may be given by the guardianship judge in accordance with Article L. 1111-6.\n* An adult assisted by their guardian or by the judge who has read and understood the information letter and signed the consent form (if the patient is under guardianship). If the guardian does not wish to give an opinion or make a decision for the patient, the guardianship judge may be consulted in accordance with Article L1223-1.\n* Patients covered by social health insurance (except AME)\n* Women of childbearing age (a woman is considered to be of childbearing age, i.e. fertile, after menarche and until she reaches menopause, unless she is permanently infertile) using at least minimally effective contraception (i.e. at least: oral progestogen-only contraception, where inhibition of ovulation is not the primary mode of action, male or female condoms with or without spermicide, diaphragm, diaphragm or sponge with spermicide) for at least 1 month and throughout the study, as well as a negative urinary pregnancy test for β-HCG at inclusion.\n* Surgically sterile women (hysterectomy, bilateral salpingectomy and bilateral oophorectomy)\n* Menopausal women: Post-menopausal status is defined as the absence of menstruation for 12 months without any other medical cause. Elevated follicle-stimulating hormone (FSH) levels in the post-menopausal interval may be used to confirm post-menopausal status in women who are not using hormonal contraception or hormone replacement therapy. However, in the absence of 12 months of amenorrhoea, a single FSH measurement is insufficient.\n\nFor schizophrenic patients\n\n* All previous treatments have failed, including the combination of clozapine (for at least 6 months with clozapine levels \\> 350 ng\u002FmL) + ECT (minimum 20 sessions)\n* Have had at least two clozapine potentiations among the following: lithium, valproic acid, beta-blockers, other antipsychotics.\n\nFor ASD patients with or without intellectual disability\n\n\\- All recommended psychoeducational measures must have been attempted with failure of the following treatments: risperidone, aripiprazole, clozapine, naltrexone, beta-blockers given for at least three months at the maximum tolerated dose.\n\nExclusion Criteria:\n\n* Minors\n* Contraindications to surgery and anaesthesia\n* Contraindications to the use of the Medical Device (diathermy, certain magnetic resonance imaging procedures, transcranial magnetic stimulation (TMS), (see section 'Contraindications' in the 'Information for Prescribers' manual for the implanted neurostimulator)\n* Contraindications to MRI and CT scans (cardiac or neural pacemakers, ferromagnetic surgical clips, implants and metallic objects, intraocular foreign bodies, pregnancy, claustrophobia, cardiac or neural pacemakers, ferromagnetic surgical clips, implants and metallic objects, intraocular foreign bodies, etc.)\n* Other medical problems interfering with the protocol and surgery\n* Pregnant women","70 Years",{"count":602,"type":21},6,[24],"Physical aggression can be defined as the use of force with the intention of causing physical injury, psychological damage or death. Pathological aggression may be associated with various psychiatric disorders. This symptom can often be improved by prescribing medication, implementing psychoeducational strategies or even electroconvulsive therapy. However, some patients exhibit such severe pathological aggression that they must be institutionalised because they pose a danger to themselves or others. These patients are then hospitalised in a unit for difficult patients (UMD) for enhanced therapeutic care. Despite this maximum level of care, the pathological aggression of a minority of patients persists, leading to a therapeutic impasse, confining the patient to the UMD for many years with social isolation, a collapsed quality of life, and major repercussions for the family. The aim of this project is to use deep brain stimulation, a controlled, reversible, adaptable and low-morbidity neurosurgical method, in six patients with pathological aggression suffering from either schizophrenia (n=3) or autism spectrum disorders (n=3). We hypothesise that the effects of deep brain stimulation (DBS) of the Sano triangle will significantly control the pathological aggression of these six patients.\n\nThis is a pilot study with randomised, crossover, double-blind evaluation. It will also provide answers regarding the safety of using SCP for this indication.",[29,606],"Schizophrenia Disorder","2026-06-05",{"date":564,"type":42},{"date":610,"type":21},"2026-07-13",{"date":612,"type":21},"2029-05-08",{"name":614,"class":115},"University Hospital, Rouen",{"id":616,"slug":617,"hasResults":12,"nctId":618,"briefTitle":619,"officialTitle":620,"acronym":4,"eligibilityCriteria":621,"healthyVolunteers":12,"sex":17,"minAge":95,"maxAge":622,"enrollmentInfo":623,"targetDuration":4,"studyType":22,"phases":625,"briefSummary":626,"conditions":627,"keywords":628,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":632,"lastUpdatePostDateStruct":633,"startDateStruct":634,"completionDateStruct":636,"leadSponsor":638,"locationsCount":50},"100551960","retrieval-based-word-learning-in-autistic-children-100551960","NCT06466876","Retrieval-Based Word Learning in Autistic Children","Retrieval-Based Word Learning in Autism Spectrum Disorder","Inclusion Criteria:\n\n* Children with autism spectrum disorder (ASD) will participate in this study. The study will be 4- to 10-years-old and will already have a community diagnosis of autism spectrum disorder. The diagnosis will be confirmed confirmed using the Autism Diagnostic Observation Schedule - 2nd edition (ADOS-2; Lord et al., 2012).\n* Because the children will be completing an experimental word learning study that requires the child to verbally produce the newly taught words, children must have verbal communication skills (i.e., be able to speak in at least simple sentences spontaneously), which will be determined in initial correspondence with the child's parent or guardian.\n* Children's primary language spoken must be English.\n* All children will pass a hearing screening.\n* Additionally, all children will score above 75 on the Leiter-3 (Roid, Miller, \\& Pomplun, 2013), a nonverbal cognitive assessment.\n\nExclusion Criteria:\n\n* Because the word learning study involves the child needing to produce the taught words non-speaking autistic children and minimally speaking autistic children (i.e., is not able to produce at least simple sentences in spontaneous speech) will be excluded from the proposed studies.\n* If the child has a history of a neurological disorder such as cerebral palsy or a known genetic disorder that causes developmental delays\u002Fdisorders\n* If the child has an un-corrected hearing loss.","10 Years",{"count":624,"type":21},64,[24],"Children on the autism spectrum sometimes have difficulty learning new words and using the newly taught information in different situations. In this study, the investigators are testing whether strategies that have been found to improve word learning in non-autistic children will also help autistic children. Specifically, the investigators aim to test whether autistic children learn words more successfully if novel words are taught by repeating the words to the child (re-study) or if the novel words are taught first with labeling each word and then quizzing the child (repeated quizzing).\n\nThe main questions it aims to answer are:\n\n* When teaching nouns (names of exotic animals), is learning stronger if autistic children re-study or engage in repeated quizzing of the newly taught words?\n* When teaching adjectives (visible features of objects, like a bumpy chair), is learning stronger if autistic children re-study or engage in repeated quizzing of the newly taught adjectives?\n* Does the word learning condition (re-study vs. repeated quizzing) impact whether autistic children are more successful in demonstrating their knowledge of the newly taught words in different contexts?\n* Are autistic features related to patterns of word learning?\n\nParticipants will:\n\n* Learn new words with half of the words being taught in one way (re-study) and the other half of the words being taught in the other way (repeated quizzing).\n* Participate in 5-minute and 1-week tests of the newly taught words to measure child learning.\n* Complete other language, thinking, and autism clinical assessments.",[29],[476,629,630,631],"word learning","retrieval practice","test effect","2026-06-04",{"date":564,"type":42},{"date":635,"type":42},"2023-07-28",{"date":637,"type":21},"2026-09-30",{"name":639,"class":115},"Louisiana State University and A&M College",{"id":641,"slug":642,"hasResults":12,"nctId":643,"briefTitle":644,"officialTitle":645,"acronym":4,"eligibilityCriteria":646,"healthyVolunteers":12,"sex":17,"minAge":125,"maxAge":96,"enrollmentInfo":647,"targetDuration":4,"studyType":22,"phases":649,"briefSummary":650,"conditions":651,"keywords":654,"overallStatus":377,"whyStopped":4,"lastUpdateSubmitDate":662,"lastUpdatePostDateStruct":663,"startDateStruct":664,"completionDateStruct":666,"leadSponsor":668,"locationsCount":50},"100643483","phase-2-clinical-trial-evaluating-the-effects-of-ganaxolone-in-children-with-autism-100643483","NCT07635862","Clinical Trial Evaluating the Effects of Ganaxolone in Children With Autism","A Randomized Controlled Trial of Ganaxolone for Children With Autism Spectrum Disorder","Inclusion Criteria:\n\n1. children between the ages of 5 years and 17 years old at enrollment\n2. diagnosis of autism spectrum disorder based on DSM-5 criteria and confirmed with the Autism Diagnostic Inventory - Revised (ADI-R) and Autism Diagnostic Observation Schedule 2nd edition (ADOS-2), or Childhood Autism Rating Scales (CARS)\n3. medical stability based on clinical interview\n4. stable medication regimens (2 weeks, with the exception of fluoxetine for 4 weeks)\n5. stable psychosocial therapies (4 weeks) prior to randomization and no plans to change treatments or intensity during the trial\n6. high rates of irritability defined as the Aberrant Behavior Checklist irritability subscale score \\> 18\n7. for participants who are sexually active, use of an effective contraceptive (e.g., birth control medications for female participants and condoms for male participants) and no plans for pregnancy throughout the trial\n8. for females, negative urine pregnancy test at baseline\n9. no planned changes in school placement\n10. for participants living within 150 miles of Stanford University, have the ability to attend site visits and attempt EEG and MRI procedures before and after the trial\n11. availability of a reliable informant who interacts with the participant regularly and can reliably complete assessments in English regarding their behaviors throughout the trial\n12. ability to participate in the testing administered in English to the extent that valid standard scores and biological samples can be obtained.\n\nExclusion Criteria:\n\n1. any unstable medical condition, such as unstable seizure disorder or heart disease\n2. any lifetime diagnosis of severe psychiatric (e.g., schizophrenia) or neurodegenerative conditions\n3. concomitant use of any neuroactive steroids or corticosteroids.\n4. history of substance abuse or active\u002Fplanned use of alcohol, opioids, or cannabinoids\n5. recent history or current suicidal ideation assessed with the Columbia-Suicide Severity Rating Scale (C-SSRS) and by clinical interview with the study physician\n6. pregnancy and mothers who are breastfeeding\n7. prior participation in any clinical trial in the 30 days prior to study entry\n8. known intolerance or hypersensitivity to ganaxolone or similar analogs\n9. Concomitant use of medications that are inducers of CYP450 3A4\u002F5, such as rifampin, carbamazepine, phenytoin, phenobarbital, and St. John's wort",{"count":648,"type":21},66,[171],"The goal of this study is to conduct a randomized, placebo-controlled trial (RCT) of ganaxolone, a neuroactive steroid (NAS), in autistic children and adolescents aged 5 to 17 years old. Ganaxolone is approved and effective for treating seizures in children as young as 2 years old who have CDKL5 deficiency disorder (CDD), a neurogenetic condition associated with developmental delays, seizure disorder, hypotonia, visual impairments, and autistic features. The primary outcome of interest for this trial is irritability on the Aberrant Behavior Checklist (ABC) because it is a common symptom of emotion dysregulation in ASD that impacts quality of life, including mental health, independence, educational opportunities, and integration into the community. The secondary domains of interest for this trial are restricted and repetitive behaviors (RRB), specifically insistence on sameness (IS), a subdomain of RRB characterized by inflexibility and a strong preference for predictable routines and familiar environments. Secondary outcome measures include the IS subscale from the Dimensional Assessment of Repetitive Behaviors (DARB) and subscales of the Clinical Global Impressions Scale for irritability (CGI-IR) and IS (CGI-IS). For participants living within 150 miles of Stanford University, we require participants to attend site visits and attempt EEG and MRI procedures before and after the trial, though we are recruiting nationally and the study can be completed without site vists.",[652,653,29],"Autism in Children","Autistic Disorder in Children and Adolescents",[103,655,656,657,658,659,660,661],"Ganaxolone","Autism disorder in children and adolescents","Ztalmy","GABA","Insistance on Sameness","Emotional Regulation Difficulties","Irritability","2026-06-03",{"date":538,"type":42},{"date":665,"type":21},"2027-01-01",{"date":667,"type":21},"2030-01-01",{"name":114,"class":115}]