[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neurodevelopmental-disorder-diagnosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neurodevelopmental-disorder-diagnosis":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,48,76,102,132,155,191],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100638936","safe-early-intervention-for-at-risk-infants-100638936",false,"NCT07596147","SAFE Early Intervention for At-Risk Infants","Investigation of the Effectiveness of the SAFE Early Intervention Approach on Upper Extremity Function, Fine Motor Skills, and Quality of Life in High-Risk Infants","SAFE-EFFECT","Inclusion Criteria:\n\n* Infants aged between 3 and 12 months corrected age Presence of neurodevelopmental risk factors including perinatal stroke, perinatal asphyxia, hypoxic-ischemic encephalopathy, germinal matrix hemorrhage, intraventricular hemorrhage, periventricular leukomalacia, or prematurity at or below 37 weeks of gestation Admission to the Developmental Pediatrics and Pediatric Physiotherapy and Rehabilitation Unit of Gazi University Faculty of Health Sciences Parent or legal guardian willing to participate and provide written informed consent\n\nExclusion Criteria:\n\n* Presence of any congenital anomaly Diagnosis of a genetic disorder Any orthopedic problem affecting upper extremity function Families unable to communicate in Turki","ALL","3 Months","12 Months",{"count":21,"type":22},34,"ESTIMATED","INTERVENTIONAL",[25],"NA","This randomized controlled study aims to investigate the effects of the SAFE early intervention approach on upper extremity function, fine motor skills, and developmental outcomes in high-risk infants aged 3-12 months. Thirty high-risk infants admitted to the Developmental Physiotherapy and Pediatric Rehabilitation Unit of Gazi University Faculty of Health Sciences will be randomly assigned to either the SAFE early intervention group or the Neurodevelopmental Treatment (NDT) group.\n\nInfants in the intervention group will receive the SAFE early intervention program for 8 weeks under the supervision of an experienced pediatric physiotherapist. The SAFE approach includes age-appropriate activities focusing on environmental enrichment, promotion of voluntary and goal-directed movements, sensory stimulation, fine motor skill development, postural control, transitional movements, and enhancement of infant-parent interaction through daily routines and home-based activities.\n\nInfants in the control group will receive conventional Neurodevelopmental Treatment (NDT) for 8 weeks. The NDT program includes age-specific activities targeting postural control, muscle tone regulation, facilitation of motor development, hand function, balance, weight transfer, and fine motor skills.\n\nFamilies will receive education regarding home-based activities and facilitation techniques specific to their infant's developmental needs. Follow-up will include home visits and weekly telephone monitoring to ensure adherence to the intervention program. Assessments will be performed before the intervention and after the 8-week intervention period by a physiotherapist blinded to group allocation.",[28,29,30],"High Risk Infant","Neurodevelopmental Disorder (Diagnosis)","Preterm",[32,33,34],"early intervention","high risk infant","upper limb function","RECRUITING","2026-05-13",{"date":38,"type":39},"2026-05-19","ACTUAL",{"date":41,"type":39},"2026-02-16",{"date":43,"type":22},"2026-07-16",{"name":45,"class":46},"Gazi University","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":60,"studyType":61,"phases":4,"briefSummary":62,"conditions":63,"keywords":64,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":4},"100634785","transdiagnostic-dimensional-profiling-of-neurodevelopmental-disorders-100634785","NCT07544199","Transdiagnostic Dimensional Profiling of Neurodevelopmental Disorders","Transdiagnostic Dimensional Profiling of Neurodevelopmental Disorders: Using a Digital Platform to Assess Domain-General and Domain Specific Cognitive Functions","RDoC-CRAB","Inclusion Criteria:\n\n* Age between 3 and 11 years;\n* First access to the NPIA service at IRCCS Eugenio Medea (Bosisio Parini);\n* Suspected neurodevelopmental or psychopathological disorder;\n* Completion of the standard clinical diagnostic pathway;\n* Availability of a compatible device (tablet or computer) for remote administration, if applicable.\n\nExclusion Criteria:\n\n* Age outside the specified range;\n* Failure to complete the diagnostic pathway;\n* Lack of access to a compatible device (for remote administration);\n* Severe sensory impairments (uncorrected blindness or deafness);\n* Motor impairments preventing use of digital devices;\n* Significant lack of understanding of the Italian language affecting task comprehension.","3 Years","11 Years",{"count":59,"type":22},300,"6 Months","OBSERVATIONAL","In recent years, the growing awareness of the multifactorial nature of neurodevelopmental disorders has stimulated interest in transdiagnostic approaches aimed at investigating underlying etiological mechanisms beyond traditional diagnostic categories. In this context, the present study seeks to provide a transdiagnostic profiling of both domain-general cognitive functions (attention, working memory, executive control) and domain-specific functions (phonological awareness, rapid naming, vocabulary, reading) underlying the main neurodevelopmental disorders in a large sample of preschool and school-age children (3-11 years), through the use of CRAB (Computerized Reading-related Assessment Battery). CRAB is a digital platform specifically developed by SUPSI and the Université de Genève to integrate, within a single testing environment, the assessment of the main domain-general and domain-specific cognitive functions underlying neurodevelopmental disorders. In particular, participating families will receive an email containing a link to access the CRAB platform, which will not include their personal data but rather a code provided by the staff of IRCCS Medea. A screen will open displaying several game-like tasks designed to measure both domain-general and domain-specific cognitive functions, which must be completed by the participating subject. The main objective is to obtain a fine-grained and multidimensional mapping of cognitive profiles prior to the standard diagnostic process, in order to identify early patterns of (a)typical or at-risk functioning.",[29],[65],"NDD, CRAB, transdiagnostical profiles, prospective study","NOT_YET_RECRUITING","2026-04-15",{"date":69,"type":39},"2026-04-22",{"date":71,"type":22},"2026-05-01",{"date":73,"type":22},"2030-01-30",{"name":75,"class":46},"IRCCS Eugenio Medea",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":17,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":23,"phases":88,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":47},"100626133","feeding-disorders-in-children-100626133","NCT07431671","Feeding Disorders in Children","Feeding Disorders in Pediatric Age: Effects of an Interdisciplinary Intervention","FEEDING","Inclusion Criteria:\n\n* Age between 2 and 7 years.\n* Diagnosis of a neurodevelopmental disorder according to DSM-5 criteria.\n* Presence of a feeding disorder.\n\nExclusion Criteria:\n\n* Presence of respiratory, cardiovascular, gastrointestinal, or neurological conditions preventing oral feeding.\n* Insufficient caregiver proficiency in the Italian language, such as to compromise completion of the questionnaires.\n* Children who are undergoing a different feeding intervention at the time of screening.","2 Years","7 Years",{"count":87,"type":22},24,[25],"Pediatric Feeding Disorders (PFDs) are conditions characterized by persistent difficulties in food intake, commonly manifesting as food selectivity, food refusal, and dysfunctional mealtime behaviors. Their prevalence in the general pediatric population ranges from 3% to 10%, with substantially higher rates reported among children with neurodevelopmental disorders. The impact of PFDs extends beyond growth and nutritional status, affecting cognitive and emotional development as well as the well-being of the entire family system. Although several treatment models have been proposed, scientific evidence supporting outpatient interventions remains limited and Italy-specific studies are lacking. Moreover, despite the availability of standardized assessment tools, feeding-related outcomes are not yet systematically addressed within outpatient clinical practice for children with neurodevelopmental disorders.\n\nThe present study aims to evaluate whether an interdisciplinary intervention protocol involving a psychologist, a speech and language therapist (SLP), and a Neuro and Psychomotor Therapist of Developmental Age (TNPEE) can improve food variety and reduce dysfunctional mealtime behaviors in this population. The study is designed as a pilot randomized controlled trial developed across five sequential phases: participant enrollment and screening using the Montreal Children's Hospital Feeding Scale (MCH-FS); baseline standardized assessment (T0) using the Pediatric Eating Assessment Tool (PediEAT) and the Short Sensory Profile (SSP); random allocation of participants to an experimental group or a control group; delivery of the interdisciplinary intervention exclusively to the experimental group; and a final standardized assessment conducted six weeks later (T1) to evaluate changes over time and between groups.\n\nThis pilot study primarily aims to assess feasibility and to estimate the variability of outcome measures; therefore, no formal sample size or power calculation was performed. The planned enrollment of 12 participants per group was determined based on feasibility considerations and in line with CONSORT recommendations for pilot trials. The proposed protocol seeks to address current gaps in the literature by systematically targeting feeding-related outcomes through an explicitly interdisciplinary approach that integrates psychological, speech and language, and neuropsychomotor perspectives in the management of PFD.",[29,91,92],"Feeding Disorder","ARFID","2026-02-25",{"date":95,"type":39},"2026-02-27",{"date":97,"type":39},"2026-01-01",{"date":99,"type":22},"2026-02-28",{"name":101,"class":46},"IRCCS San Raffaele Roma",{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":17,"minAge":84,"maxAge":109,"enrollmentInfo":110,"targetDuration":4,"studyType":23,"phases":112,"briefSummary":114,"conditions":115,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":131},"100621931","phase-3-tap-grin-interventional-study-on-patients-with-grin-related-neurodevelopmental-disorders-100621931","NCT07377032","TAP-GRIN: Interventional Study on Patients With GRIN-related Neurodevelopmental Disorders","L-serine Supplementation in Patients With GRIN-related Neurodevelopmental Disorders: Multicentre Protocol for an Aggregated Series of Randomised, Placebo-controlled N-of-1 Trials","Inclusion Criteria:\n\n* Clinical diagnosis of a GRIN-related neurodevelopmental disorder (GRIN-NDD)\n* Presence of a pathogenic or likely pathogenic loss-of-function (LoF) variant in GRIN1, GRIN2A, GRIN2B, or GRIN2D\n* Parent(s), caregiver(s), or legally authorised representative(s) have been informed of the nature of the study and have provided written informed consent.\n* Participants who are able to do so have provided written informed consent or assent, according to local regulations and cognitive capacity.\n* Parent(s)\u002Fcaregiver(s) are willing and able to comply with study procedures and visits, in the opinion of the investigator.\n* Participants who have previously received L-serine supplementation are willing to discontinue L-serine for at least one week prior to the baseline observation period.\n\nExclusion Criteria:\n\n* Age younger than 2 years at screening.\n* Known hypersensitivity or intolerance to L-serine, placebo, or any excipients used in the study formulations.\n* Presence of a clinically significant unstable medical condition (other than epilepsy) that, in the investigator's judgement, may place the participant at increased risk or interfere with study participation.\n* Any other significant disease or disorder that may compromise participant safety, affect study outcomes, or impair the participant's ability to complete the study procedures.\n* Inadequate supervision by parent(s) or caregiver(s), as judged by the investigator.\n* Participation in another clinical trial involving an investigational medicinal product within the previous 6 months.\n* Female participants who are pregnant or breastfeeding.\n* Presence of a GRIN1, GRIN2A, GRIN2B, or GRIN2D variant for which a clear loss-of-function effect cannot be demonstrated.","30 Years",{"count":111,"type":22},40,[113],"PHASE3","The goal of this clinical study is to find out whether L-serine dietary supplementation helps improve overall clinical functioning in children and young adults (2-30 years) with GRIN-related neurodevelopmental disorders (GRIN-NDD) caused by loss-of-function (LoF) variants in GRIN1, GRIN2A, GRIN2B, or GRIN2D. It will also assess the safety and tolerability of L-serine.\n\nThe main questions it aims to answer are:\n\nDoes L-serine improve overall clinical status, measured mainly by the Clinical Global Impression-Severity (CGI-S) score?\n\nDoes L-serine improve behaviour, cognition, adaptive functioning, motor skills, sleep, and (in those with epilepsy) seizure frequency and EEG findings?\n\nWhat side effects or medical problems occur during L-serine compared with placebo?\n\nDo neurophysiological measures (including TMS-EMG\u002FTMS-EEG) change with treatment and potentially act as biomarkers of response?\n\nResearchers will compare L-serine to a placebo (maltodextrin powder with similar appearance\u002Ftexture) using a randomised, double-blind, placebo-controlled \"n-of-1\" approach, where each participant receives both treatments in alternating periods. Results from multiple single-patient trials will then be combined (aggregated) to estimate the overall treatment effect across the study population.\n\nParticipants will:\n\nComplete a 4-week baseline period with assessments (and seizure diary use where applicable)\n\nReceive L-serine and placebo in alternating 3-month periods within each cycle (minimum 2 cycles, up to 4 cycles; each cycle lasts 6 months)\n\nTake the assigned study product by mouth 3 times per day at 500 mg\u002Fkg\u002Fday (maximum 30 g\u002Fday for participants ≥60 kg)\n\nHave the first 7 days of each 3-month period treated as washout, with data from that week not analysed\n\nAttend regular clinic visits for clinical exams, safety labs, and standardized assessments of global status, behaviour\u002Fcognition, motor function, and sleep\n\nIf they have epilepsy: keep a seizure diary and undergo EEG assessments after each treatment period\n\nIn some sites (Italy and France): undergo TMS-based neurophysiology testing\n\nOptionally, a subset may join a cellular biomarker substudy (blood collection to generate iPSC-derived neuronal models and organoids) to explore treatment effects in variant-specific lab models.",[116,117,118,119,120,121,29],"GRIN-related Disorders","GRIN1","GRIN2A","GRIN2B","GRIN2D","Epilepsy","2026-01-26",{"date":124,"type":39},"2026-01-29",{"date":126,"type":39},"2025-08-29",{"date":128,"type":22},"2028-06",{"name":130,"class":46},"Meyer Children's Hospital IRCCS",3,{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":17,"minAge":84,"maxAge":4,"enrollmentInfo":140,"targetDuration":4,"studyType":23,"phases":142,"briefSummary":143,"conditions":144,"keywords":145,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":47},"100581520","expanding-ngs-data-with-optical-genome-mapping-ogm-100581520","NCT06851377","Expanding NGS Data with Optical Genome Mapping (OGM)","Expanding NGS Data with Optical Genome Mapping (OGM): More Comprehensive Variant Detection in Children with Unexplained Rare Genetic Disorders","OGM","Inclusion Criteria:\n\n* individuals without a molecular diagnosis (negative to ES\u002FCMA analyses);\n* individuals with genetic diagnoses that explain only one component of their primary phenotype;\n* individuals carrying one or more variants of uncertain clinical significance\n* individuals with a phenotype highly reminiscent of clinically and molecularly well-defined syndromes (i.e., Marfan Syndrome) but negative to routine molecular analysis.\n\nExclusion Criteria:\n\n* individuals who have not undergone initial diagnostic genetic tests (ES\u002FCMA)",{"count":141,"type":22},60,[25],"Over 50% of pediatric neurological and neurodevelopmental disorders lack a molecular diagnosis after standard DNA sequencing and molecular karyotyping. This is due to technical limitations, incomplete variant interpretation, and inadequate genotype-phenotype correlations. New sequencing technologies are crucial for clinical decision-making, offering complete profiles of variants in a patient's DNA to personalize treatment. Optical Genome Mapping (OGM) can detect nearly all structural variants in one experiment. This project aims to use OGM alongside NGS to improve diagnostic yield in 60 children with severe disorders who tested negative for NGS\u002FCMA.",[29],[146],"Optical Genome Mapping, neurodevelopmental disorders, genome sequencing","2025-02-24",{"date":149,"type":39},"2025-02-28",{"date":151,"type":39},"2024-05-23",{"date":153,"type":22},"2026-12",{"name":75,"class":46},{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":162,"sex":17,"minAge":163,"maxAge":4,"enrollmentInfo":164,"targetDuration":4,"studyType":23,"phases":166,"briefSummary":167,"conditions":168,"keywords":172,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":187,"leadSponsor":189,"locationsCount":4},"100578227","paiact-ai-driven-act-chatbot-for-mental-health-triage-and-service-evaluation-100578227","NCT06808555","Pai.ACT: AI-Driven ACT Chatbot for Mental Health Triage and Service Evaluation","Pai.ACT: An Artificial Intelligence-Driven Chatbot-Assisted ACT Mobile Platform With Mental Health Triage - A Randomized Controlled Trial and Regional Service Evaluation","Inclusion Criteria:\n\nThe participants of the study are primary caregivers, specifically parents, must be Cantonese-speaking residents of Hong Kong.\n\nEligible parents are required to cohabitate with a child aged 2 to 9 years who has either a confirmed or suspected diagnosis of a neurodevelopmental condition, including Autism Spectrum Disorder (ASD), Attention-Deficit\u002FHyperactivity Disorder (ADHD), or Developmental Delay (DD). These conditions must be recognised by the Child Assessment Service of the Department of Health and meet the diagnostic criteria specified in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). The diagnosis or suspected diagnosis must be formally documented in the child's case profile maintained at the collaborating non-governmental organisations.\n\nExclusion Criteria:\n\n* Parents diagnosed with severe mental illnesses.\n* Pregnant parents or those less than six months postpartum.\n* Parents with a developmental disability that impairs their ability to understand the program's content.\n* Parents with cognitive, language, communication, visual, or hearing impairments that could hinder their comprehension of the intervention content.\n* Parents actively participating in other psychosocial, psychoeducational, or parenting interventions.",true,"19 Years",{"count":165,"type":22},340,[25],"Parents of children with special needs in Hong Kong often face limited psychological support, which can negatively impact the child rehabilitation process and the well-being of parent-child relationships. To address this gap, we have developed Pai.ACT, the first deep learning-based mental health advisory system for parents.\n\nPai.ACT features an AI chatbot that integrates the counselling principles of Acceptance and Commitment Therapy (ACT) through natural language processing, providing parents with a human-like voice-to-text experience. Using data from chatbot interactions, the Pai.ACT platform offers assessments regarding the individual's psychological inflexibility status and delivers stratified mental health interventions by:\n\n* Low-risk: Users access self-help ACT digital modules tailored to their specific psychological inflexibility processes.\n* Moderate-risk: In addition to the self-help modules, users receive 4-6 sessions of video-conferencing-based ACT interventions (45-60 minutes per session) conducted by our trained counseling team.\n* High-risk: Users are directed to specialized mental health services provided by collaborating units.\n\nThe study includes a regional randomised controlled trial (RCT) in Hong Kong's Sha Tin District, in collaboration with the Shatin District Office. The goal of this regional study is to evaluate the feasibility, acceptability, and potential efficacy of combining AI-driven mental health support across all of Hong Kong. Focus group interviews will also explore parents' perceptions of Pai.ACT and help identify the most effective service model for scaling its use.\n\nPai.ACT provides accessible and comprehensive mental health services to Chinese-speaking parents, helping to alleviate the psychological burden of caregiving. By integrating mental health support with child rehabilitation services and non-governmental organisations, Pai.ACT has the potential to enhance family caregivers' well-being, reduce stigma associated with special needs children, and promote more significant mental health awareness in Chinese-speaking communities.",[169,170,29,171],"Autism Spectrum Disorder","Attention Deficit Disorder With Hyperactivity (ADHD)","Dyslexia",[173,174,175,176,177,178,179,180,181,182],"Smartphone-delivered Therapy","Deep learning","Acceptance and Commitment Therapy","Parents","Children with Special Needs","Parental Support","Artificial Intelligence in Healthcare","Psychological Interventions","Parenting Stress","Regional Randomized Controlled Trial","2025-02-10",{"date":185,"type":39},"2025-02-12",{"date":183,"type":22},{"date":188,"type":22},"2027-02-28",{"name":190,"class":46},"Chinese University of Hong Kong",{"id":192,"slug":193,"hasResults":11,"nctId":194,"briefTitle":195,"officialTitle":195,"acronym":196,"eligibilityCriteria":197,"healthyVolunteers":162,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":198,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":200,"conditions":201,"keywords":202,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":217},"100571943","neonatal-multiexposure-to-medical-devices-plasticizers-endocrine-disruption-mixture-effects-and-neurodevelopmental-disorders-100571943","NCT06726824","NEOnatal Multiexposure to Medical Devices Plasticizers: Endocrine Disruption MIXture Effects and Neurodevelopmental Disorders","NEOMIX WP3","Inclusion Criteria:\n\n* Live patient who participated in the ARMED NEO study, included at the Clermont-Ferrand or Lille hospitals\n* Patient whose holders of parental authority have expressed their non-opposition to their participation in the study\n\nExclusion Criteria:\n\n* Patient whose guardians have expressed opposition to their participation in the study\n* Patient with no French speaking parent\n* patient",{"count":199,"type":22},97,"The goal of this observational study is to evaluate the neurodevelopment of children from the ARMED NEO cohort through the ASQ3 score.\n\nDose the multiexposure to medical devices plasticizers during the neonatal intensive care unit stay increases the risk of developing neurodevelopmental disorders ? Patients (their parents) will complète several questionnaires (ASQ3, environnemental survey, EPICES score) during a planned teleconsultation with the research team",[29],[203,204,205,206,207],"Neurodevelopmental disorder","Multiexposure","Medical devices","Plasticizers","Cocktail effects","2024-12-06",{"date":210,"type":39},"2024-12-10",{"date":212,"type":22},"2024-12",{"date":214,"type":22},"2025-12",{"name":216,"class":46},"University Hospital, Clermont-Ferrand",2]