[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Istituto per la Ricerca e l'Innovazione Biomedica\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":432},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,16,0,[8,51,83,109,137,160,186,217,244,268,292,316,339,364,387,408],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100642616","cognitive-training-in-virtual-reality-for-autism-100642616",false,"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","ALL","4 Years","6 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"NA","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.",[27,28],"Autism","Autism Spectrum Disorder",[30,31,32,33,34,35,36,28,37],"autism","children","Virtual Reality Rehabilitation System","Cognitive Training","Executive Functions","Visual Attention","Visuo-Spatial Memory","Autism Spectrum Condition","NOT_YET_RECRUITING","2026-06-09",{"date":41,"type":42},"2026-06-11","ACTUAL",{"date":44,"type":21},"2026-09-01",{"date":46,"type":21},"2027-03-31",{"name":48,"class":49},"Istituto per la Ricerca e l'Innovazione Biomedica","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":58,"sex":16,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":50},"100643723","assessment-of-motor-reserve-in-the-preclinical-stages-of-dementia-100643723","NCT07634055","Assessment of Motor Reserve in the Preclinical Stages of Dementia","Assessment of Motor Reserve in the Preclinical Stages of Dementia.","Inclusion Criteria:\n\n* Patients with Mild Cognitive Impairment (MCI) group\n\n  * Diagnosis of MCI according to the international criteria of the National Institute on Aging-Alzheimer's Association (NIA-AA) (Albert et al., 2011; McKhann et al., 2011).\n  * Age between 40 and 85 years.\n  * Native Italian speaker or sufficient Italian language proficiency to understand the tests.\n  * Signed informed consent provided by the participant or by a legal representative.\n* Healthy subjects group\n\n  * Normal performance on the neuropsychological screening assessment. Age between 40 and 85 years.\n  * Native Italian speaker or sufficient Italian language proficiency to understand the tests.\n  * Signed informed consent.\n\nExclusion Criteria:\n\n* Patients with Mild Cognitive Impairment (MCI) group\n\n  -History of psychiatric or neurological disorders not attributable to MCI. Use of psychotropic medications.\n* Healthy subjects group\n\n  * History of psychiatric or neurological disorders.\n  * Use of psychotropic medications.\n  * Disabling medical comorbidities or medical conditions interfering with motor function.",true,"18 Years","85 Years",{"count":62,"type":21},200,"OBSERVATIONAL","Mild Cognitive Impairment (MCI) is a clinical condition associated with an increased risk of progression to dementia. Although cognitive alterations have traditionally been the main focus of investigation, growing evidence suggests that motor changes may also emerge during the early stages of cognitive decline and may represent potential preclinical indicators of disease.\n\nIn this context, the concept of motor reserve has emerged as a construct of increasing interest, although it remains insufficiently defined. Understanding how motor characteristics may contribute to an individual's ability to compensate for or modulate the effects of cognitive decline could provide new insights into the mechanisms involved in the early stages of dementia.\n\nTherefore, the present monocentric observational study aims to further investigate the concept of motor reserve in healthy individuals and in patients with Mild Cognitive Impairment (MCI) through a multidimensional approach based on clinical, neuropsychological, behavioral, and kinematic assessments. In particular, standardized motor tasks and quantitative movement analyses using a sensor-based medical device will be employed to objectively characterize motor performance.The study plans to recruit approximately 200 participants, including healthy individuals and patients with MCI, enrolled at the Neuropsychology Outpatient Clinic of the Neurology Unit of the University Hospital \"Renato Dulbecco\" in Catanzaro. In the healthy group, the relationship between motor reserve and motor performance will be investigated, while in patients with MCI the relationship between cognitive reserve, motor reserve, clinical and neuropsychological status, and motor performance will be explored.\n\nThe findings of this study may contribute to a broader and more operational definition of motor reserve and support the identification of potential motor biomarkers associated with early cognitive decline. These findings may ultimately contribute to the development of innovative strategies for the early detection and monitoring of conditions at risk of progression to dementia.",[66],"Mild Cognitive Impairment (MCI)",[68,69,70,71,72,73],"mci","mild cognitive impairment","Healthy populations","motor reserve","Motor biomarkers","Kinematic assessment","RECRUITING","2026-06-03",{"date":77,"type":42},"2026-06-08",{"date":79,"type":21},"2026-07",{"date":81,"type":21},"2027-07",{"name":48,"class":49},{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":58,"sex":16,"minAge":59,"maxAge":90,"enrollmentInfo":91,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":50},"100638752","the-neuroanatomical-and-psychological-correlates-of-suggestibility-in-patients-with-non-responsive-chronic-migraine-100638752","NCT07617441","The Neuroanatomical and Psychological Correlates of Suggestibility in Patients With Non-Responsive Chronic Migraine","SIGMA","Inclusion Criteria for Non-Responsive Chronic Migraine subjects:\n\n* adults aged ≥ 18 years and ≤ 75 years;\n* diagnosis of non-responsive chronic migraine (NRCM) according to ICHD-3 beta criteria;\n* presence of at least 8 migraine days per month associated with disability (MIDAS ≥ 11), and insufficient response after 6 weeks or inability to tolerate at least three previously prescribed migraine preventive agents, i.e., resistance to standard therapy for at least 6 weeks;\n* signed informed consent.\n\nInclusion Criteria for healthy subjects are:\n\n* adults aged ≥ 18 years and not older than 75 years;\n* absence of a diagnosis of NRCM according to ICHD3beta or other relevant -neurological disorders as assessed during the medical history taken at the headache center;\n* signed informed consent.\n\nExclusion Criteria:\n\n* older than 75 years;\n* children\n* pregnant or breastfeeding women;\n* history of alcohol or substance abuse;\n* affected by concomitant neurological, cardiovascular, or cerebrovascular diseases;\n* liver disease or kidney disease;\n* psychiatric disorders (psychosis, major depression, bipolar disorder).\n* diagnosis or history of migraine (for healthy subjects).","75 Years",{"count":62,"type":21},"Chronic migraine is a disabling neurovascular disorder and one of the leading causes of years lived with disability worldwide. Population-based studies report a worrying level of resistance to currently available treatments in clinical practice. For this reason, the clinical and scientific community is increasingly investigating new therapeutic approaches aimed at reducing the burden of symptoms and improving patients' quality of life.\n\nAmong the alternative therapeutic approaches explored in migraine research, the placebo effect has emerged as a potentially important mechanism. However, the duration and intensity of its beneficial effects on migraine symptoms are still poorly understood. In particular, there is a need to identify biological and clinical markers that may predict which patients are more likely to benefit from placebo-related mechanisms.\n\nOne of the most promising factors is suggestibility, namely the tendency of an individual to respond to suggestions, expectations, or contextual influences. It is possible that patients with non-responsive chronic migraine may show different levels of suggestibility, which could influence the effectiveness of placebo-related responses.\n\nTo investigate this hypothesis, it is first necessary to better understand the psychobiological characteristics of patients with non-responsive chronic migraine (NRCM). Therefore, the primary aim of this monocentric observational study is to characterize the neurobiological and psychological profile of individuals affected by NRCM through advanced magnetic resonance imaging techniques (connectomics) and a comprehensive battery of psychodiagnostic assessments, including the evaluation of suggestibility.\n\nThe study plans to recruit at least 100 patients with NRCM and 100 healthy control subjects matched for age and sex. By comparing participants with high and low levels of suggestibility, the study aims to identify new neurobiological profiles (bio-phenotypes) associated with these characteristics. These findings may contribute to future research on the placebo effect and help develop more personalized treatment strategies for patients with chronic migraine who do not respond to conventional therapies.",[94],"Chronic Migraine Headache",[96,97,98,99,100],"Chronic migraine","Suggestibility","Placebo effect","Connectomics","Biomarkers","2026-05-28",{"date":103,"type":42},"2026-06-01",{"date":105,"type":21},"2026-07-01",{"date":107,"type":21},"2029-05",{"name":48,"class":49},{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":58,"sex":16,"minAge":59,"maxAge":117,"enrollmentInfo":118,"targetDuration":4,"studyType":22,"phases":119,"briefSummary":120,"conditions":121,"keywords":125,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":50},"100639143","digital-engagement-for-lifelong-health-100639143","NCT07612852","Digital Engagement for Lifelong Health","Digital Engagement for Lifelong Prevention and Health Improvement","DELPHI","Inclusion Criteria:\n\n* Apparent good general health status, confirmed by medical history and initial self-assessment.\n* Ability to understand the study information and provide informed consent.\n* Availability and motivation to participate for the entire duration of the study (12 months).\n* Access to a smartphone compatible with the DELPHI application.\n* Willingness to wear the wearable devices for continuous monitoring of physiological parameters.\n* Basic familiarity with mobile applications or willingness to receive training on their use.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Presence of severe chronic diseases in active phase (e.g., oncological, cardiovascular, or neurological diseases).\n* Acute or unstable conditions that could compromise participation in the protocol.\n* Current pregnancy.\n* Diagnosed major cognitive or psychiatric disorders that hinder understanding of or adherence to the protocol.\n* Current use of medications that significantly affect the parameters being monitored (e.g., psychotropic drugs, beta-blockers).\n* Simultaneous participation in other clinical studies.\n* Logistical difficulties that prevent frequent interaction with the platform (e.g., lack of connection, unwillingness to attend periodic follow-ups).","65 Years",{"count":62,"type":21},[24],"The DELPHI project (Digital Engagement for Lifelong Prevention and Health Improvement) aims to develop, implement, and validate an advanced digital platform for promoting well-being and personalized prevention of chronic non-communicable diseases in healthy adults. By integrating wearable sensors, artificial intelligence, federated learning, and the Human Digital Twin (HDT) paradigm, the DELPHI platform is designed to collect, analyze, and interpret multidimensional data in order to deliver dynamic and personalized recommendations for healthy lifestyles.\n\nThe study adopts a multicenter, randomized controlled pilot design, with a maximum duration of 12 months per participant. A total of 200 healthy adults aged 18-65 will be recruited in Southern Italy (Sicily, Campania, and Basilicata) and randomly assigned to either: (1) an experimental group using the full DELPHI platform, including personalized recommendations, adaptive content, and continuous feedback; or (2) a control group using a basic version limited to passive monitoring.\n\nAs a non-clinical primary prevention pilot study, DELPHI aims to assess the operational feasibility, usability, and acceptability of the platform in real-world settings, while also exploring preliminary signals of impact on health and lifestyle domains without confirmatory purposes. Secondary objectives include monitoring physiological indicators, adherence to the app and wearable devices, and evaluating the feasibility of implementing the platform in workplace environments.\n\nData collection will rely on wearable devices, digital questionnaires, and behavioral analysis, with strong safeguards for personal data protection in compliance with GDPR and advanced security approaches such as federated learning and encryption.\n\nSpecific subgroups, including workers from the Fondazione Don Carlo Gnocchi (FDG) as well as university staff and students, will be involved in targeted assessments related to mental well-being and distress. In addition, workers from the FDG will test a virtual reality module designed to evaluate biomechanical overload risks during manual handling activities in simulated environments. These additional physiological and virtual reality components are exploratory and non-diagnostic.\n\nOverall, DELPHI seeks to provide a solid foundation for the adoption of predictive and personalized models in digital health, contributing to the development of a sustainable and accessible prevention ecosystem, particularly in Southern Italy.",[122,123,124],"Life Style, Healthy","Risk Reduction","Health Promotion",[126,127,128],"health","digitalization","prevention","2026-05-25",{"date":131,"type":42},"2026-05-29",{"date":133,"type":42},"2026-05-04",{"date":135,"type":21},"2027-03-30",{"name":48,"class":49},{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":16,"minAge":18,"maxAge":144,"enrollmentInfo":145,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":147,"conditions":148,"keywords":149,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":50},"100623958","static-balance-assessment-in-children-with-asd-using-vrrs-100623958","NCT07403396","Static Balance Assessment in Children With ASD Using VRRS","Quantitative Assessment of Static Balance in Children With Autism Spectrum Disorder Using VRRS","Inclusion Criteria:\n\n* Diagnosis of Autism;\n* QI ≥ 60\n\nExclusion Criteria:\n\n* Motor deficits due to another clinical condition","13 Years",{"count":146,"type":21},50,"Children with autism spectrum disorder (ASD) often exhibit postural and balance difficulties, which can impact daily functioning and motor development. Quantitative assessment using Virtual Reality Rehabilitation System (VRRS) provides precise measurements to better understand these deficits and their potential relationship with cognitive functioning. This observational trial aims to evaluate static balance in children with ASD aged 6-10 years. A total of 50 participants were enrolled, with 10 children in each age group. Static balance was assessed using the VRRS and a specific balance task, measuring 13 quantitative parameters including Mean Distance Centre of Pressure (MD\\_COP), Root Mean Square of Distance (RMS), Total Excursion (ESC), Velocity (VEL) , and Sway area (SWAY). Cognitive functioning was also recorded using standardized IQ assessments to explore correlations between balance performance and cognitive abilities. All data were stored in a dedicated database for analysis.\n\nParticipant recruitment: Children diagnosed with ASD will be recruited from the clinical facilities of the Institute for Biomedical Research and Innovation of the National Research Council of Italy (IRIB-CNR) in Messina as part of an ongoing research program.\n\nWithdrawn criteria: Participants will be considered withdrawn if any of the following occurs: (1) participant chooses to withdraw from the study at any time, (2) intolerable adverse effects, (3) major violation of the study protocol, and (4) other circumstances that would endanger the health of the subject if he\u002Fshe would to continue his\u002Fher participation in the trial.\n\nVirtual Reality Rehabilitation system: The VRRS, a sophisticated technological innovation, aims to generate immersive and interactive settings intended for therapeutic and evaluative objectives. Through the utilization of virtual reality (VR) technology, it constructs diverse scenarios, tasks, and activities in a controlled digital environment, fostering engagement. Primarily crafted for rehabilitation purposes, the VRRS features adaptable programs addressing various therapeutic requirements, encompassing motor skill enhancement, cognitive challenges, and assessments related to balance.",[27,28],[27,150,32,151],"Virtual Reality","Postural control","2026-02-04",{"date":154,"type":42},"2026-02-11",{"date":156,"type":42},"2026-01-02",{"date":158,"type":21},"2026-04-30",{"name":48,"class":49},{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":4,"eligibilityCriteria":166,"healthyVolunteers":11,"sex":16,"minAge":167,"maxAge":168,"enrollmentInfo":169,"targetDuration":4,"studyType":22,"phases":170,"briefSummary":171,"conditions":172,"keywords":174,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":50},"100621179","using-virtual-reality-to-improve-emotion-understanding-in-children-with-autism-100621179","NCT07367256","Using Virtual Reality to Improve Emotion Understanding in Children With Autism","Efficacy of a Virtual Reality-Mediated Intervention on Emotion Recognition and Understanding in Children With Autism Spectrum Disorder","Inclusion Criteria:\n\n* Language in sentences\n* Ability to narrate events not present\n* QS\u002FQI\\>80\n\nExclusion Criteria:\n\n* presence of other medical disorders","7 Years","10 Years",{"count":20,"type":21},[24],"Autism Spectrum Disorders (ASD) are neurodevelopmental conditions characterized by difficulties in social interaction, communication, and in understanding one's own and others' mental and emotional states. In particular, skills related to the recognition, understanding, and regulation of emotions represent a significant area of vulnerability in children with high-functioning ASD, with important consequences for social and relational functioning.\n\nThe present study aims to evaluate the effectiveness of an intervention protocol designed to enhance socio-emotional understanding, with a specific focus on the recognition of basic and complex emotions, the expansion of emotional vocabulary, the association between situations, thoughts, and emotions, and the differentiation between thoughts and emotions. Furthermore, the study seeks to investigate the role of immersive technology (Oculus) as a potential facilitator of emotional learning compared to a traditional intervention approach. The sample will consist of children with a diagnosis of high-functioning ASD, aged between 7 and 10 years, with sentence-level language abilities, the capacity to narrate non-present events, and an intellectual quotient above 80 (assessed using the Griffiths Scales or the WISC-IV). Participants will be divided into two groups: an experimental group (OCULUS), which will receive the intervention mediated by the use of Oculus technology, and a control group which will undergo the same protocol without technological support.",[27,173],"Autism Disorder",[30,31,175,176,177],"emotional skills","virtual reality","emotional recognition","2026-01-16",{"date":180,"type":42},"2026-01-26",{"date":182,"type":21},"2026-02-02",{"date":184,"type":21},"2026-07-31",{"name":48,"class":49},{"id":187,"slug":188,"hasResults":11,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":192,"eligibilityCriteria":193,"healthyVolunteers":58,"sex":16,"minAge":194,"maxAge":195,"enrollmentInfo":196,"targetDuration":4,"studyType":22,"phases":198,"briefSummary":199,"conditions":200,"keywords":204,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":50},"100577566","ai-and-vr-devices-for-eating-behavior-rehabilitation-100577566","NCT06799962","AI and VR Devices for Eating Behavior Rehabilitation","Assistance and Rehabilitation of Eating Behavior Through Devices Based on Artificial Intelligence and Virtual Reality","ARCADIA-VR","Inclusion Criteria:\n\n* Clinical diagnosis of Anorexia Nervosa or Bulimia Nervosa according to DSM-5-TR (APA, 2013) and ICD-11, confirmed by a public hospital setting\n* Body Mass Index (BMI) between 16 and 32\n* Disorder present for at least 6 months\n* No other concurrent psychotherapeutic interventions during the study\n* All participants with a previous diagnosis will be re-evaluated and confirmed through assessment and consent by expert professionals in the research team (i.e., a neuropsychiatrist and a clinical psychologist)","15 Years","40 Years",{"count":197,"type":21},80,[24],"Eating disorders (ED) affect the relationship with food and body image. Virtual reality (VR), combined with artificial intelligence (AI), offers new clinical solutions, overcoming traditional cognitive behavioral therapy (CBT). The ARCADIA VR project aims to develop devices to treat ED through personalized VR systems (e.g. Enhanced Body-Swap for anorexia, Emotional Rescripting for bulimia) and AI predictive algorithms to monitor severity, risk and efficacy of treatments. These approaches promise better and faster results, improving diagnosis and treatment.",[201,202,203],"Eating Disorders","Anorexia Nervosa","Bulimia Nervosa",[201,202,203,150,205,206,207,208],"Artificial Intelligence","Body Perception","Emotional Regulation","Cognitive Behavioral Therapy","2025-04-29",{"date":211,"type":42},"2025-04-30",{"date":213,"type":42},"2025-01-30",{"date":215,"type":21},"2026-01-31",{"name":48,"class":49},{"id":218,"slug":219,"hasResults":11,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":223,"eligibilityCriteria":224,"healthyVolunteers":58,"sex":16,"minAge":225,"maxAge":4,"enrollmentInfo":226,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":228,"conditions":229,"keywords":232,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":50},"100553799","cyber-human-systems-for-personalized-well-being-and-health-100553799","NCT06490783","Cyber-Human Systems for Personalized Well-being and Health","CybeR-human systEms for perSonalIzed mentaL and physIcal wEll-beiNg and Health","RESILIENT","Inclusion Criteria:\n\n* healthy male and female aged 60 years and older\n* signing of informed consent\n\nExclusion Criteria:\n\n* chronic diseases\n* cardiovascular disease\n* presence of dementia and\u002For depression\n* presence of confirmed paranoid or psychotic symptoms","60 Years",{"count":227,"type":21},10,"The purpose of the present study is to evaluate the effectiveness of using multi-parameter monitoring devices in the elderly to improve their quality of life not already understood as the absence of disease but in a logic that is intrinsically linked to the body-mind relationship, which is increasingly significant as biological age advances. The study will be conducted on a sample of volunteer elderly subjects who will wear devices capable of constantly monitoring vital parameters such as heart rate, physical activity, sleep quality, stress levels and higher level activities, linked sensory and cognitive aspects ecologically integrated with the elderly person's living environment, in the sense of an evaluative and qualitative focus on relationships within the person's area of action\u002Finteraction, possibly supported and stimulated by individualized and easily usable activities. The signals interpreted and returned by the technology to the elderly person who uses it can also act as a reassuring self-assessment of even normal body states, sometimes experienced as threatening and anxiogenic, thus stressful. The collection and management of these data may serve as a reference to the recognition of distress signals and complex experiences (e.g., depressive) that normally have significant effects on mental health, understood as intrinsically linked to the health of the body.",[230,231],"Geriatric Health Services","Health Services for the Elderly",[233,234,205,235,236],"elderly","wellbeing","quality of life","AI",{"date":238,"type":42},"2025-05-01",{"date":240,"type":42},"2024-07-01",{"date":242,"type":21},"2026-05-31",{"name":48,"class":49},{"id":245,"slug":246,"hasResults":11,"nctId":247,"briefTitle":248,"officialTitle":249,"acronym":250,"eligibilityCriteria":251,"healthyVolunteers":58,"sex":16,"minAge":59,"maxAge":252,"enrollmentInfo":253,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":254,"conditions":255,"keywords":258,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":262,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":50},"100551634","contact-relationship-in-neonatal-intensive-care-unit-100551634","NCT06462638","COntact RElationship in Neonatal Intensive Care Unit","Study on the Developmental Value of the Physical and Vocal Contact Relationship Between Preterm Infant in the NICU and Caregivers (Mother, Father, Nurse)","CORE in NICU","Inclusion Criteria:\n\n* For infants: Infants with gestational age between 33 and 36 weeks, weighing around 2kg (LBW - low birth weight), in whom life-threatening conditions have been averted and in stable medical condition will be included in the study.\n* For parents: Male and female adults aged between 18 and 50 years.\n\nExclusion Criteria:\n\n* For infants: Presence of congenital anomalies, neurological disorders, genetic syndromes, and any other condition of developmental atypicality.\n* For parents: Parents under 18 years of age; Parents with diagnosed psychiatric disorders and\u002For sensory disabilities; single parents.","50 Years",{"count":197,"type":21},"The present research project aims to explore the value that contact relationships between caregivers and the preterm infant may have in terms of promoting developmental and maturational processes,by attending to the neurobehavioral states of the infant in response to maternal and paternal voice.\n\nThe study is aimed at furthering the still underdeveloped knowledge regarding the possible effects of the paternal voice on the neurobehavioral states of the preterm infant in the crib, comparing them with the effects of exposure to the maternal voice and the voice of a familiar but non-parental figure, such as the NICU nurse.\n\nThese behavioral states will also be observed as a function of the psychological condition of the parents, investigating the presence of a possible postpartum depressive condition and\u002For anxiety of the mother and symptomatology attributable to perinatal affective disorders in the fathers, which are often overlooked; and again, the neurobehavioral responses of the infants will be correlated with the neurophysiological responses of the parents\u002Fnurses who interact with them through voice and touch.\n\nThe research aims to have a direct impact on both parents and health care personnel: in addition to questionnaires dedicated to screening parents for perinatal psychological disorders, artificial intelligence systems will be used to intercept possible postpartum depression early by recording the maternal voice, enabling the activation of a psychological support intervention and reducing the negative impact that a postpartum depression has on the early mother-child relationship. In addition, information on parent-child interactive modalities will be able to further guide the intake of assignment and particularly the accompaniment of parents during the time of hospitalization.",[256,257],"Preterm Birth","Postpartum Depression",[259,260,261],"preterm birth","contact relationship","postpartum depression",{"date":238,"type":42},{"date":264,"type":42},"2024-11-01",{"date":266,"type":21},"2026-10-31",{"name":48,"class":49},{"id":269,"slug":270,"hasResults":11,"nctId":271,"briefTitle":272,"officialTitle":273,"acronym":4,"eligibilityCriteria":274,"healthyVolunteers":11,"sex":16,"minAge":275,"maxAge":276,"enrollmentInfo":277,"targetDuration":4,"studyType":22,"phases":279,"briefSummary":280,"conditions":281,"keywords":282,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":286,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":291,"locationsCount":50},"100554093","early-neurodivergent-developmental-trajectories-in-autism-and-in-response-to-the-esdm-intervention-100554093","NCT06494605","Early Neurodivergent Developmental Trajectories in Autism and in Response to the ESDM Intervention","Early Neurodivergent Developmental Trajectories in Toddlers and Young Children on the Autism Spectrum and Effectiveness of the Early Start Denver Model in Community Settings","Inclusion Criteria:\n\n* unimpaired hand use\n* parent agreement to have a caregiver present during all home sessions\n* attendance at all intake sessions\n* permission to videotape evaluations and ESDM treatment\n* Italian as one primary language of the parent\n* unimpaired hearing and vision\n* developmental quotient of 35 or higher on the Griffith Scale\n* meets all of these autism spectrum disorder diagnostic criteria through the Autism Diagnostic Observation Schedule (ADOS; cutoff score of 12 if child produces no words or 10 if child produces some words)\n\nExclusion Criteria:\n\n* serious parental substance abuse\n* parental self-report of bipolar disorder or psychosis\n* known genetic syndromes\n* serious medical conditions (e.g., encephalitis, concussion, seizure disorder)\n* significant sensory impairment\n* birth weight \\\u003C1600 grams and\u002For gestational age \\\u003C 34 weeks\n* history of intraventricular hemorrhage\n* known exposure to neurotoxins (including alcohol, drugs)\n* non-Italian-speaking parents","18 Months","36 Months",{"count":278,"type":21},33,[24],"Early support is thought to be key to ensure a better quality of life for young children on the autism spectrum. Among early support, different evidence-based approaches have combined the principles of developmental and behavioral science within a naturalistic and interactive frame and grouped under the umbrella of Naturalistic Developmental Behavioral Interventions (NDBI). In the context of NDBIs, the Early Start Denver Model is a manualized support that has reported evidence of efficacy for therapist-, group- and caregiver-implemented support, in multiple research as well as community based settings, different countries and languages (Rogers \\& Dawson, 2010). Understanding the effects of support characteristics and intensity on individual learning has a major impact on the delivery systems organization and policies, sustainability in low resources community settings and to provide the necessary support to the family. However, a direct comparison among different types and intensity of early support in community setting and relatively low access to standardized and intensive programs, have not been adequately explored. For this reason, the aim of this study is to investigate, in a community setting in the Italian context, the impact of ESDM and support intensity on individual developmental trajectories.",[28],[30,283,31,284,285],"early support","ESDM","individual trajectories",{"date":238,"type":42},{"date":288,"type":42},"2021-11-01",{"date":290,"type":21},"2025-05-31",{"name":48,"class":49},{"id":293,"slug":294,"hasResults":11,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":298,"eligibilityCriteria":299,"healthyVolunteers":58,"sex":16,"minAge":300,"maxAge":225,"enrollmentInfo":301,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":302,"conditions":303,"keywords":305,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":310,"startDateStruct":311,"completionDateStruct":313,"leadSponsor":315,"locationsCount":50},"100551735","synchrony-and-reciprocity-of-body-movements-and-prosody-between-psychotherapist-and-patient-100551735","NCT06463951","Synchrony and Reciprocity of Body Movements and Prosody Between Psychotherapist and Patient","Study on the Synchrony and Reciprocity of Bodily Movements and Prosody Between Psychotherapist and Patient During Psychotherapy","RECiPROsody","Inclusion Criteria:\n\n* Male and female adults between the ages of 20 and 60 years old who are referred to the HCC Italy Clinical and Psychotherapy Research Center\n\nExclusion Criteria:\n\n* Patients under 20 years of age\n* Presence of paranoid or psychotic symptoms\n* Admissions to psychiatric Operative Units that have occurred within the last year since the start of psychotherapy at the HCC Italy Clinical and Psychotherapy Research Center","20 Years",{"count":20,"type":21},"Modern psychotherapy focuses on co-regulation, where therapist and patient interactively manage emotions. This co-regulation is seen in nonverbal communication like facial expressions, gestures, and prosody (vocal pitchs). Studies show body movements and even skin conductance synchronize between patients and therapists during sessions.\n\nThe RECiPROsody project builds on this by using technology (cameras, sensors) to record and analyze these synchronies in psychotherapy sessions. This project aims to understand how this \"attunement\" between therapist and patient contributes to successful therapy.\n\nResearchers will explore how patients and therapists interact using a mobile app that records video, audio, physiological signals (heart rate), and movements. Questionnaires will assess patient well-being and therapist experience.\n\nBy studying these micro-processes, RECiPROsody hopes to gain insights into how the therapeutic relationship develops, including the connections between physical reactions, nonverbal communication, and overall progress. This knowledge can improve psychotherapeutic techniques and highlight the importance of the nonverbal communication in therapy.",[304],"Relationship, Professional Patient",[306,307,308,309],"psychotherapy","facial mimicry","fidgeting","relational synchrony",{"date":238,"type":42},{"date":312,"type":42},"2024-10-01",{"date":314,"type":21},"2026-09-30",{"name":48,"class":49},{"id":317,"slug":318,"hasResults":11,"nctId":319,"briefTitle":320,"officialTitle":321,"acronym":322,"eligibilityCriteria":323,"healthyVolunteers":11,"sex":16,"minAge":59,"maxAge":4,"enrollmentInfo":324,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":326,"conditions":327,"keywords":329,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":334,"startDateStruct":335,"completionDateStruct":337,"leadSponsor":338,"locationsCount":50},"100528539","modeling-outcome-in-patients-with-acquired-brain-injuries-100528539","NCT06162091","Modeling Outcome in Patients With Acquired Brain Injuries","Modeling Trajectories of Functional Outcome in Patients With Severe Acquired Brain Injuries Using a Non-Linear Dynamic Evolution Approach.","MOF-ABI","Inclusion Criteria:\n\n* patients with clinical diagnosis of severe acquired brain injury of different etiology (traumatic, hemorrhagic vascular,ischemic vascular, anoxic, infectious, other etiology\n* interval since the acute occurrence that led to the clinical condition of ≤3 months duration\n* age of 18 years or older\n* informed consent signed by family member\u002Fcaregiver\u002Fsupporting caregiver\n\nExclusion Criteria:\n\n* Positive remote medical history of pre-existing disabling neurological or orthopedic conditions and psychiatric disorders",{"count":325,"type":21},190,"Acquired brain injury (ABI) is the leading cause of death and disability worldwide. The degree of severity varies according to a combination of numerous demographics, etiological, clinical, cognitive, behavioral, psychosocial and environmental factors, which can interfere with the effectiveness of rehabilitation interventions and, therefore, with the final outcome.\n\nThe most important goal of the modern clinic is to predict in time the progression of possible recovery after the brain injury event in order to provide more effective treatment, but the high heterogeneity and clinical variability and the unpredictability of the onset of comorbidities makes this a hard target to reach.\n\nIn recent years, artificial intelligence algorithms have been applied to more precisely define the role of critical variables that can help clinical practice to predict the final outcome. The classical approach of these algorithms provides only probabilistic values on the final outcome, without considering the typology of clinical interventions and overall complications that may appear throughout the hospitalization period.\n\nThe objective of this multicentric study is to define a new statistical approach that can describe the dynamics of individual clinical changes occuring during the inpatient intensive rehabilitation care period. The proposed approach combines a principal component analysis (PCA) for dimension reduction (capturing the maximum amount of information and reducing the dimensionality problem) and a nonlinear mathematical modeling for describing the evolution of the clinical course in terms of the resulting new PCA dimensions. By using this approach, we may determine the individual patient's temporal trajectories while examining particular clinical factors. The secondary objective of this study is to validate a new version of the Early Rehabilitation Barthel Index (ERBI), a well-known clinical scale used to measure functional changes in patients with severe acquired brain injury.",[328],"Brain Injuries",[330,331,332,333],"acquired brain injury","functional outcome","Modeling trajectories","mathematical models",{"date":238,"type":42},{"date":336,"type":42},"2024-01-10",{"date":290,"type":21},{"name":48,"class":49},{"id":340,"slug":341,"hasResults":11,"nctId":342,"briefTitle":343,"officialTitle":344,"acronym":4,"eligibilityCriteria":345,"healthyVolunteers":58,"sex":16,"minAge":17,"maxAge":346,"enrollmentInfo":347,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":349,"conditions":350,"keywords":351,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":358,"startDateStruct":360,"completionDateStruct":362,"leadSponsor":363,"locationsCount":50},"100583123","the-impact-of-sensory-integration-on-attention-in-autism-100583123","NCT06872229","The Impact of Sensory Integration on Attention in Autism","How the Simultaneous or Delayed Presentation of Visual and Auditory Stimuli Affects Response Accuracy and Reaction Times in Participants With Autism Spectrum Condition (ASC) During an Association Task.","Inclusion Criteria:\n\n* Diagnosis of Autism\n* QI ≥ 80\n\nExclusion Criteria:\n\n* significant hearing or visual impairments\n* presence of other medical disorders\n* history of psychiatric diagnosis","12 Years",{"count":348,"type":21},100,"The study aims to examine how the mode of presentation of visual and auditory stimuli-separate or simultaneous-affects accuracy and reaction time in visual-auditory association in participants with Autism Spectrum Condition (ASC) compared to neurotypical individuals. The study aims to evaluate whether sensory overlap (simultaneous stimuli) increases cognitive load and decreases performance, while stimulus separation (separate presentation of visual and auditory stimuli) may facilitate processing and improve performance, especially in participants with ASC. Participants will be divided into two main groups: the first consisting of individuals with ASD and the second of neurotypical individuals. Each group will be exposed to two modes of stimulus presentation: simultaneous mode, in which visual and auditory stimuli are presented at the same time, and separate mode, in which visual and auditory stimuli are presented separately with a time interval between each. Participants will be required to complete visual-auditory association tasks. In addition to assessment of reaction time and accuracy, psychophysiological parameters will be recorded to measure cognitive load and physiological reaction to stimuli. The main hypotheses are that the simultaneous presentation of visual and auditory stimuli will increase cognitive load and reduce accuracy and reaction time in individuals with ASC, while the separate mode will improve performance, especially in the group with ASC. This study could provide important insights into how stimulus presentation mode affects learning and performance in participants with ASC, suggesting that stimulus separation could be a useful strategy for optimizing sensory processing and improving learning in educational and therapeutic settings.",[27,28],[30,352,353,354,355,356],"autism spectrum condition","utism spectrum disorder","sensory overload","sensory processing","sensory integration","2025-03-06",{"date":359,"type":42},"2025-03-12",{"date":361,"type":42},"2025-03-01",{"date":46,"type":21},{"name":48,"class":49},{"id":365,"slug":366,"hasResults":11,"nctId":367,"briefTitle":368,"officialTitle":369,"acronym":4,"eligibilityCriteria":370,"healthyVolunteers":58,"sex":16,"minAge":371,"maxAge":168,"enrollmentInfo":372,"targetDuration":4,"studyType":22,"phases":374,"briefSummary":375,"conditions":376,"keywords":377,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":380,"startDateStruct":382,"completionDateStruct":384,"leadSponsor":386,"locationsCount":50},"100529913","emotional-skills-training-with-social-robot-100529913","NCT06179953","Emotional Skills Training with Social Robot","Evaluate the Effect of Social Robot Mediation on the Development of Emotional Skills","Inclusion Criteria:\n\n* Language in sentences\n* use of connectors\n* ability to narrate events not present\n* ADOS level: module 2\n* Griffiths: QS\\>75\n\nExclusion Criteria:\n\n* presence of other medical disorders","5 Years",{"count":373,"type":21},20,[24],"Autism is a neurodevelopmental disorder that involves difficulties especially in the sphere of social interaction, social communication, and restricted and stereotyped behavior patterns.\n\nIn particular, emotional regulation is a central developmental skill. In fact, the emotional dysregulation observed in children with autism results in increased social and behavioral difficulties over time.\n\nTherefore, the present protocol aims to test the role of a human-assisted social robot as a mediator of social-emotional understanding intervention for children with autism spectrum disorders (ASD).\n\nThe children, will be divided into two groups, an experimental one in which training will be conducted through the use of social robot and control group which will be conducted through traditional therapy.",[28],[30,31,175,378],"social robot","2025-01-16",{"date":381,"type":42},"2025-01-17",{"date":383,"type":42},"2023-06-05",{"date":385,"type":21},"2025-04-24",{"name":48,"class":49},{"id":388,"slug":389,"hasResults":11,"nctId":390,"briefTitle":391,"officialTitle":392,"acronym":4,"eligibilityCriteria":393,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":168,"enrollmentInfo":394,"targetDuration":4,"studyType":22,"phases":395,"briefSummary":396,"conditions":397,"keywords":398,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":400,"lastUpdatePostDateStruct":401,"startDateStruct":403,"completionDateStruct":405,"leadSponsor":407,"locationsCount":50},"100566546","exploring-virtual-reality-as-an-intervention-for-food-selectivity-a-clinical-trial-100566546","NCT06656585","Exploring Virtual Reality As an Intervention for Food Selectivity: a Clinical Trial","Evaluation of the Effect of a Food Selectivity Intervention Through Virtual Reality in Children with Autism Spectrum Disorders","Inclusion Criteria:\n\n* Food selectivity upon parental referral\n* Child with diagnosis of autism\n\nExclusion Criteria:\n\n* presence of other medical disorders",{"count":20,"type":21},[24],"Food selectivity is a common challenge among children with Autism Spectrum Disorder (ASD), with significant impacts on their nutrition and well-being. The main purpose of this study is to promote children's active participation in mealtime routines and encourage experimentation with new foods through an approach that emphasizes joy and serenity during mealtimes. The study will involve children with ASD between the ages of 4 and 10 years, of both sexes. Food selectivity will be assessed through interviews with parents and the use of specially created cards.\n\nThe protocol will include 45-minute sessions, twice a week, for a total of 48 sessions. The children will wear an Oculus headset and be exposed to the foods through this virtual reality tool, enhancing their engagement and willingness to try new foods in a fun and immersive way.",[27,28],[30,31,399,176],"food selectivity","2024-10-23",{"date":402,"type":42},"2024-10-24",{"date":404,"type":42},"2024-09-01",{"date":406,"type":21},"2025-07-17",{"name":48,"class":49},{"id":409,"slug":410,"hasResults":11,"nctId":411,"briefTitle":412,"officialTitle":413,"acronym":4,"eligibilityCriteria":414,"healthyVolunteers":11,"sex":16,"minAge":18,"maxAge":415,"enrollmentInfo":416,"targetDuration":4,"studyType":22,"phases":417,"briefSummary":418,"conditions":419,"keywords":420,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":425,"startDateStruct":427,"completionDateStruct":429,"leadSponsor":431,"locationsCount":50},"100552052","exploring-theatrical-expressive-tasks-for-children-with-asd-100552052","NCT06468072","Exploring Theatrical Expressive Tasks for Children With ASD","Exploring the Impact of Theatrical Expressive Tasks in Children With Autism Spectrum Disorder (ASD).","Inclusion Criteria:\n\n* Diagnosis of autism spectrum disorder;\n* Age between 6 and 11 years;\n* IQ over 80 assessed by means of WISC-IV.\n\nExclusion Criteria:\n\n* Presence of other medical disorders","11 Years",{"count":373,"type":21},[24],"Autism Spectrum Disorder (ASD), according to the diagnostic criteria of Diagnostic and Statistical Manual of Mental Disorders- V Edition (DSM-5), is a disorder involving (a) persistent deficits in social communication, social interaction and (b) patterns of restricted and stereotyped behavior and\u002For interests and\u002For activities. Specifically, impairment in social interaction manifests itself in different areas of individual functioning and through various facets: social-emotional reciprocity, poor understanding of social rules, reduced sharing of interests, emotions or feelings, reduced or absent theory of mind, inability to initiate or respond to social interactions (turn-taking in conversation), and difficulties in the use of communication. Facial expressions, vocal intonation, postures and gestures are crucial components of non-verbal communication that play a fundamental role in social-communicative functions. However, people with ASD may show significant deficits in these forms of expression, negatively affecting the ability to generate an appropriate social response, which is essential for initiating and maintaining social interactions. Children with ASD tend to avoid eye contact with others and show little or no interest in people, often looking past them or away from them. This behavior contributes to presenting them as \"markedly aloof and distant\". The aim of the study is to explore the effect of specific expressive tasks, conducted by highly qualified personnel, in a group setting, by means of targeted theatrical activities. These activities include exercises focusing on the use of voice and posture, the variety of vocal intonations and the harmonization between verbal production and facial expressiveness. In the context of this study, 20 children will be involved, divided into an experimental group and a control group. The experimental group will include 10 children with ASD who voluntarily participate in activities organized by the IRIB-CNR of Messina. These children, aged between 6 and 11 years, present a medium-high level of cognitive functioning, as assessed by the Wechsler Intelligence Scale for Children- IV Edition (WISC-IV) cognitive test. In parallel, the control group will consist of 10 normo-typical children, selected from the Istituto Comprensivo San Francesco di Paola of Messina, having the same age group, who will not participate in the experimental activities.",[27,28],[30,31,421,422,423],"expressiveness","theater","technology","2024-06-14",{"date":426,"type":42},"2024-06-21",{"date":428,"type":42},"2024-05-01",{"date":430,"type":21},"2026-06-30",{"name":48,"class":49},""]