[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06213090":3,"trial-entities:NCT06213090":81,"trial-summary:NCT06213090":90},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":27,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":31,"interventions":34,"primary_outcomes":35,"secondary_outcomes":40,"sex":47,"minimum_age":29,"maximum_age":29,"healthy_volunteers":15,"eligibility_criteria":48,"std_ages":52,"locations":56,"central_contacts":72,"overall_officials":73,"references":74,"see_also_links":75},"NCT06213090","NeuroClinical","Patterns of Neurodevelopmental Disorders","Patterns of Disease, Outcomes and Treatment Response in Children With Neurodevelopmental Disorders","RECRUITING","2030-12-31","2026-04","2026-04-16","2024-02-01","Richard Frye","OTHER",false,"The purpose of this study is to systematically evaluate the results of medical investigations to identify symptom and biological patterns and common etiologies of neurodevelopmental disorders.","Although neurodevelopmental disorders are very prevalent (for example Autism affects 1 out of every 36 children and dyslexia affects up to 15% of the population), the etiology of such disorders is not known. The purpose of this investigation is to identify common etiologies of neurodevelopmental disorders (i.e., speech delay, global developmental delay, autism) and determine if it is possible to find early indicators of the diagnosis and foster the potential for a better prognosis of these disorders. At this time the investigators examine patients with neurodevelopment disorders with various medical investigations, but the results of these investigations are not systematically evaluated. One of the goals of this research is to systematically examine this information in order to identify patterns of test abnormalities that have not been previously described. Another goal of this research is to identify the common etiologies typically identified by the medical evaluation, so we can further refine our approach. In addition, the investigators now have the ability to evaluate biological samples for biomarkers that have potential to be diagnostically useful.",[19,20,21,22,23,24,25,26],"Neurodevelopmental Disorders","Autism Spectrum Disorder","Pediatric Autoimmune Neuropsychiatric Disorder Associated With Streptococcal Infection","Pediatric Acute-Onset Neuropsychiatric Syndrome","Down Syndrome","Epilepsy","Mitochondrial Encephalomyopathies","Cerebral Folate Deficiency",[],"OBSERVATIONAL",null,[],{"count":32,"type":33},1000,"ESTIMATED",[],[36],{"measure":37,"description":38,"timeFrame":39},"Number of Patients with Specific Medical abnormalities","It is unknown if a specific set of biological abnormalities contribute to the formation of many types of neurodevelopmental disorders. The study is intended to identify the relationship between biological abnormalities and neurodevelopmental disorders. The chart will be reviewed for medical diagnoses other than the primary neurodevelopmental disorders.","up to 7 years",[41,44],{"measure":42,"description":43,"timeFrame":39},"The number of children with abnormal clinical lab","It is unknown if a abnormalities in specific clinical laboratories are associated with specific neurodevelopmental disorders. The study is intended to identify the relationship between biological abnormalities and neurodevelopmental disorders. The medical chart will be reviewed to determine the number of children with a specific medical disorder who have abnormalities in specific clinical labs.",{"measure":45,"description":46,"timeFrame":39},"The number of children who respond to specific treatments","Various behavioral and medical treatments are used for many types of neurodevelopmental disorders but the effectiveness for many of these treatments is not known. The study is intended to identify the relationship between biological abnormalities (and their treatments) and neurodevelopmental disorders. The medical chart will be review to determine the treatments applied to each participant and the participants response.","ALL",{"inclusion":49,"exclusion":50,"raw_text":51},[],[],"Inclusion Criteria:\n\nNeurodevelopmental delays Clinical visit at an Rossignol Medical Center\n\nExclusion Criteria:\n\n\\-",[53,54,55],"CHILD","ADULT","OLDER_ADULT",[57],{"facility":58,"status":8,"city":59,"state":60,"zip":61,"country":62,"contacts":63,"geoPoint":69},"Rossignol Medical Center","Phoenix","Arizona","85050","United States",[64],{"name":65,"role":66,"phone":67,"email":68},"Richard E Frye, MD, PhD","CONTACT","281-546-8377","drfrye@rossignolmedicalcenter.com",{"lat":70,"lon":71},33.44838,-112.07404,[],[],[],[76,78],{"label":58,"url":77},"https:\u002F\u002Frossignolmedicalcenter.com\u002F",{"label":79,"url":80},"Autism Discovery and Treatment Foundation","https:\u002F\u002Fwww.autismdiscovery.org\u002F",{"nct_id":4,"conditions":82,"biomarkers":89},[20,83,23,84,85,86,87,88],"Cerebral folate transport deficiency","Mitochondrial encephalomyopathy","Neurodevelopmental Disorder","Pediatric acute-onset neuropsychiatric syndrome","Pediatric autoimmune neuropsychiatric disorder associated with streptococcal infection","Seizure Disorder",[],{"nct_id":4,"found":91,"summary":92,"prompt_version":102},true,{"design":93,"status":94,"heading":95,"summary":96,"follow_up":97,"word_count":98,"commitments":99,"compensation":100,"drugs_mentioned":101},"This is an observational study aiming to enroll 1000 participants. It is not testing an intervention.","completed","Understanding Neurodevelopmental Disorders Study","This study is looking at patterns in neurodevelopmental disorders like Autism Spectrum Disorder and Down Syndrome. Researchers want to understand why these conditions happen and find common causes. They will do this by carefully reviewing medical test results from patients seen at Rossignol Medical Center who have neurodevelopmental delays. The goal is to identify new patterns in these results and find early signs that could lead to better outcomes. This study is not testing a new treatment; instead, it's an observational study where researchers will analyze existing medical information. The study aims to enroll 1000 participants. Success will be measured by the number of patients found to have specific medical abnormalities over a period of up to 7 years. The current recruitment status is unclear.","Participants will be followed for up to 7 years to measure specific medical abnormalities.",125,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]