[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06006637":3,"trial-entities:NCT06006637":107,"trial-summary:NCT06006637":110},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":36,"secondary_outcomes":41,"sex":48,"minimum_age":49,"maximum_age":50,"healthy_volunteers":51,"eligibility_criteria":52,"std_ages":66,"locations":68,"central_contacts":98,"overall_officials":104,"references":105,"see_also_links":106},"NCT06006637","2041726","Integrated Platform for Measuring and Reducing Symptoms of Autism Spectrum Disorder","RECRUITING","2026-08-15","2024-12","2025-10-14","2023-10-17","State University of New York - Upstate Medical University","OTHER",true,"This study will consist of a randomized, double-blind, sham-controlled clinical trial at SUNY Upstate Medical University and Mt. Sinai Medical Center with 80 autistic children evaluating the effects of transcranial photobiomodulation (tPBM) on multiple clinically validated scales.","The proposed intervention will noninvasively deliver near infra-red (NIR) light - transcranial Photobiomodulation (tPBM) - to the brains of autistic children. The NIR light is delivered to specific brain areas by Cognilum, a wearable device developed by Jelikalite. The Cognilum system is a non-invasive headband medical device specifically designed to safely and comfortably deliver tPBM to autistic children. Cognilum has been designated as a non-significant risk breakthrough device by the Food and Drug Administration. This study will consist of a randomized, double-blind, sham-controlled clinical trial at SUNY Upstate Medical University and Mt. Sinai with 80 autistic children using Cognilium device and measuring the impact using multiple clinically validated scales.\n\nHypothesis 1: Significant reduction of average Childhood Autism Rating Scores (CARS; before and after treatment comparison) in the active group compared to sham-control group.\n\nHypothesis 2: Significant change in average scores (before and after treatment comparison) on the Social Responsiveness Scale (SRS), and Clinical Global Impression - Improvement (CGI-I) scale in the active group compared to sham control group.",[18],"Autism Spectrum Disorder",[20,18],"Transcranial photobiomodulation","INTERVENTIONAL","TREATMENT",[24],"NA",{"count":26,"type":27},80,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DEVICE","Cognilum TM: Light Treatment Condition","The children will wear the CognilumTM device for approximately 10 minutes at a time, twice a week, for a period of 10 weeks.",[34,35],"CognilumTM","Sham control",[37],{"measure":38,"description":39,"timeFrame":40},"Childhood Autism Rating Scale, Second edition","Psychometrically sound measure for identifying children with autism and their symptom severity through quantifiable ratings based on direct observation. Raw scores may range from 15 to 60, which are then converted to T-scores. Higher scores indicate greater severity.","10 weeks",[42,45],{"measure":43,"description":44,"timeFrame":40},"Social Responsiveness Scale, Second Edition","Psychometrically sound measure for identifying the presence and severity of social impairment within the autism spectrum and differentiates it from that which occurs in other disorders. Raw scores may range from 65 to 260, which are then converted to T-scores. Higher scores indicate greater severity.",{"measure":46,"description":47,"timeFrame":40},"Clinical Global Impressions Scale","A well-established, brief assessment of the clinician's view of the patient's global functioning prior to and after initiating intervention. Ratings range from 1 (Normal) to 7 (Among the most severe).","ALL","2 Years","8 Years",false,{"inclusion":53,"exclusion":57,"raw_text":65},[54,55,56],"Ages 2 - 8","Autism spectrum disorder diagnosis","CARS-2 score of 30 - 45",[58,59,60,61,62,63,64],"CARS scores less than 30 or over 45.","Taking psychotropic medications.","Having skin lesions on scalp","Having history of seizures","Having history of abnormal EEG","Being a relative of the PI or a researcher","Having implanted devices (including cochlear implants).","Inclusion Criteria:\n\n* Ages 2 - 8\n* Autism spectrum disorder diagnosis\n* CARS-2 score of 30 - 45\n\nExclusion Criteria:\n\n* CARS scores less than 30 or over 45.\n* Taking psychotropic medications.\n* Having skin lesions on scalp\n* Having history of seizures\n* Having history of abnormal EEG\n* Being a relative of the PI or a researcher\n* Having implanted devices (including cochlear implants).",[67],"CHILD",[69,86],{"facility":70,"status":7,"city":71,"state":71,"zip":72,"country":73,"contacts":74,"geoPoint":83},"Mt. Sinai Medical Center","New York","10029","United States",[75,80],{"name":76,"role":77,"phone":78,"email":79},"Alexander Kolevzon, MD","CONTACT","212-659-8752","alexander.kolevzon@mssm.edu",{"name":81,"role":77,"email":82},"Catherine Sancimino, PhD","catherine.sancimino@mssm.edu",{"lat":84,"lon":85},40.71427,-74.00597,{"facility":87,"status":7,"city":88,"state":71,"zip":89,"country":73,"contacts":90,"geoPoint":95},"Golisano Center for Special Needs","Syracuse","13210",[91],{"name":92,"role":77,"phone":93,"email":94},"Henry S Roane, PhD","315-464-3555","roaneh@upstate.edu",{"lat":96,"lon":97},43.04812,-76.14742,[99,103],{"name":100,"role":77,"phone":101,"email":102},"William E Sullivan, PhD","315-464-3932","sullivaw@upstate.edu",{"name":92,"role":77,"phone":93,"email":94},[],[],[],{"nct_id":4,"conditions":108,"biomarkers":109},[18],[],{"nct_id":4,"found":14,"summary":111,"prompt_version":121},{"design":112,"status":113,"heading":114,"summary":115,"follow_up":116,"word_count":117,"commitments":118,"compensation":119,"drugs_mentioned":120},"This is a randomized, double-blind, sham-controlled study involving 80 autistic children. This means some children will receive the active light treatment, and others will receive a sham (inactive) treatment, without anyone knowing which they are getting.","completed","Cognilum™ Light Treatment for Autism Spectrum Disorder","This study is testing a device called Cognilum™ that uses light therapy (transcranial photobiomodulation or tPBM) to help reduce symptoms of Autism Spectrum Disorder. The Cognilum™ device delivers near infra-red (NIR) light to specific brain areas. Researchers want to see if this light treatment can improve scores on scales that measure autism symptoms, like the Childhood Autism Rating Scale (CARS-2). You might be able to join if you are an autistic child between 2 and 8 years old with a CARS-2 score between 30 and 45. The study is looking for 80 participants and its current status is unclear.","The primary endpoint is measured at 10 weeks, which is when the treatment period ends.",99,"Children will wear the Cognilum™ device for about 10 minutes at a time, twice a week, for 10 weeks.","Not stated in the trial record.",[],null]