Nctid:
NCT06228157
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-03"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000001321", "term"=>"Autistic Disorder"}], "ancestors"=>[{"id"=>"D000067877", "term"=>"Autism Spectrum Disorder"}, {"id"=>"D000002659", "term"=>"Child Development Disorders, Pervasive"}, {"id"=>"D000065886", "term"=>"Neurodevelopmental Disorders"}, {"id"=>"D000001523", "term"=>"Mental Disorders"}], "browseLeaves"=>[{"id"=>"M4623", "name"=>"Autistic Disorder", "asFound"=>"Autistic Disorder", "relevance"=>"HIGH"}, {"id"=>"M25603", "name"=>"Ganglion Cysts", "relevance"=>"LOW"}, {"id"=>"M16358", "name"=>"Synovial Cyst", "relevance"=>"LOW"}, {"id"=>"M206", "name"=>"Autism Spectrum Disorder", "relevance"=>"LOW"}, {"id"=>"M5903", "name"=>"Child Development Disorders, Pervasive", "relevance"=>"LOW"}, {"id"=>"M5902", "name"=>"Developmental Disabilities", "relevance"=>"LOW"}, {"id"=>"M30644", "name"=>"Neurodevelopmental Disorders", "relevance"=>"LOW"}, {"id"=>"M4815", "name"=>"Mental Disorders", "relevance"=>"LOW"}, {"id"=>"M14473", "name"=>"Psychotic Disorders", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M11014", "name"=>"Lidocaine", "relevance"=>"LOW"}, {"id"=>"M17558", "name"=>"Vitamins", "relevance"=>"LOW"}, {"id"=>"M17548", "name"=>"Vitamin B 12", "relevance"=>"LOW"}, {"id"=>"M9934", "name"=>"Hydroxocobalamin", "relevance"=>"LOW"}, {"id"=>"M17546", "name"=>"Vitamin B Complex", "relevance"=>"LOW"}, {"id"=>"T476", "name"=>"Vitamin B12", "relevance"=>"LOW"}, {"id"=>"T441", "name"=>"Cobalamin", "relevance"=>"LOW"}, {"id"=>"T444", "name"=>"Cyanocobalamin", "relevance"=>"LOW"}, {"id"=>"T451", "name"=>"Methylcobalamin", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Arrhythmia Agents", "abbrev"=>"AnArAg"}, {"name"=>"Channel Blockers", "abbrev"=>"ChanBlk"}, {"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Micronutrients", "abbrev"=>"Micro"}, {"name"=>"Hematinics", "abbrev"=>"Hemat"}, {"name"=>"Vitamins", "abbrev"=>"Vi"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"DOUBLE", "whoMasked"=>["INVESTIGATOR", "OUTCOMES_ASSESSOR"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>0}}, "statusModule"=>{"whyStopped"=>"ethical issues", "overallStatus"=>"WITHDRAWN", "startDateStruct"=>{"date"=>"2024-02-05", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-03", "completionDateStruct"=>{"date"=>"2024-05-15", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-03-08", "studyFirstSubmitDate"=>"2024-01-19", "studyFirstSubmitQcDate"=>"2024-01-19", "lastUpdatePostDateStruct"=>{"date"=>"2024-03-12", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-29", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-05-05", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Childhood Autism Rating Scale", "timeFrame"=>"day 1 and day 20", "description"=>"In the Childhood Autism Rating Scale, the rater observes the behavior of the child in specific situations and assigns scores based on a series of descriptive items. Each item is scored on a range of 0 to 4, with 0 indicating no abnormality and 4 indicating severe abnormality. The rater also considers the overall impression and severity of the child, resulting in a total score. The total score falls between 15 and 60, with higher scores indicating a higher level of autism severity."}], "secondaryOutcomes"=>[{"measure"=>"Children's Communication Checklist", "timeFrame"=>"day 1 and day 20", "description"=>"This checklist was to assess language abilities in children aged 2-16. It consists of 70 items divided into eight subscales, including vocabulary, grammar, comprehension, expression, communication, regulation, fluency, and nonverbal communication. Scores range from 0-280, with higher scores indicating better language ability."}, {"measure"=>"Social Interaction Assessment Scale", "timeFrame"=>"day 1 and day 20", "description"=>"This scale was developed by American psychiatrist Eric Schopler and colleagues to assess social interaction and behavior in children with autism and related disorders. It consists of 29 items divided into three subscales, including social interaction, maladaptive behavior, and language/communication. Scores range from 0-87, with higher scores indicating better social interaction and behavior."}, {"measure"=>"Children's Depression Inventory", "timeFrame"=>"day 1 and day 20", "description"=>"This inventory was developed by American psychologist Maria Kovacs to assess depression in children aged 7-17. It consists of 27 items covering aspects such as sad mood, self-evaluation, life satisfaction, insomnia, and early morning awakening. Scores range from 0-54, with higher scores indicating greater severity of depression."}, {"measure"=>"Childhood Anxiety Sensitivity Index", "timeFrame"=>"day 1 and day 20", "description"=>"This index was developed by Australian psychologist Ronald Rapee and colleagues to assess anxiety sensitivity in children aged 8-15. It consists of 18 items covering physical sensations, cognition, and behavior. Scores range from 0-54, with higher scores indicating greater anxiety sensitivity."}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Autistic Disorder"]}, "descriptionModule"=>{"briefSummary"=>"The goal of this clinical trial is to explore efficacy of stellate ganglion block Children with Autistic Disorder. The main question it aims to answer is:\n\nCan stellate ganglion block improve the Autistic Disorder in children? Children with Autistic Disorder will be divided into the control group and experimental group evenly. All the patients were provided with routine therapy, while the patients in the experimental group were given stellate ganglion block. The Childhood Autism Rating Scale of the two groups of patients before and after treatment are evaluated.", "detailedDescription"=>"Autistic Disorder in children is becoming increasingly more. The goal of this clinical trial is to explore efficacy of stellate ganglion block Children with Autistic Disorder. The main question it aims to answer is:\n\nCan stellate ganglion block improve the Autistic Disorder in children? Children with Autistic Disorder will be divided into the control group and experimental group evenly. All the patients were provided with routine therapy, while the patients in the experimental group were given stellate ganglion block. The Childhood Autism Rating Scale of the two groups of patients before and after treatment are evaluated."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD"], "maximumAge"=>"12 years", "minimumAge"=>"6 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Diagnosed as Autistic Disorder.\n* Aged between 6 years old and 12 years old.\n* No contraindications to stellate ganglion block.\n\nExclusion Criteria:\n\n* Other significant physical or neurodevelopmental disorders.\n* Other significant medical conditions"}, "identificationModule"=>{"nctId"=>"NCT06228157", "acronym"=>"SGB-gudu", "briefTitle"=>"Efficacy of Stellate Ganglion Block in Children With Autistic Disorder", "organization"=>{"class"=>"OTHER", "fullName"=>"People's Hospital of Zhengzhou University"}, "officialTitle"=>"A Randomized Controlled Trial To Explore the Efficacy of Stellate Ganglion Block in Children With Autistic Disorder", "orgStudyIdInfo"=>{"id"=>"2024-KY-0119-018"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"the experimental group", "description"=>"The study lasts 20d for each patient. During the treatment, All the participants are provided with the routine rehabilitation therapy.\n\nBased on the invention above, the patients in the experimental group were provided with stellate ganglion block, using 1.5ml of 2% Lidocaine hydrochloride (1ml: 0.5mg) and 500ug of Vitamin B12 (1ml: 0.5g)", "interventionNames"=>["Behavioral: Routine therapy", "Procedure: Stellate ganglion block"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"the control group", "description"=>"The study lasts 20d for each patient. During the treatment, All the participants are provided with the routine rehabilitation therapy.", "interventionNames"=>["Behavioral: Routine therapy"]}], "interventions"=>[{"name"=>"Routine therapy", "type"=>"BEHAVIORAL", "description"=>"The study lasts 20d for each patient. During the treatment, All the participants are provided with the routine therapy, which included routine rehabilitation, cognitive training.", "armGroupLabels"=>["the control group", "the experimental group"]}, {"name"=>"Stellate ganglion block", "type"=>"PROCEDURE", "description"=>"Based on the invention above, the patients in the experimental group were provided with Stellate ganglion block , using 1.5ml of 2% Lidocaine hydrochloride (1ml: 0.5mg) and 500ug of Vitamin B12 (1ml: 0.5g). The percutaneous approach via the paratracheal route was used for Stellate ganglion block. The operator stood on the side of the block, instructed the patient to lie supine with a thin pillow placed below the shoulders, and tilted the head 45° towards the blocked side, fully exposing the neck. Then, routine disinfection of the neck skin was performed. The puncture site was located 2.5 cm above the sternoclavicular joint and 1.5 cm lateral to the midline of the neck.", "armGroupLabels"=>["the experimental group"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"450000", "city"=>"Zhengzhou", "state"=>"Henan", "country"=>"China", "facility"=>"Zheng Da yi Yuan Hospital", "geoPoint"=>{"lat"=>34.75778, "lon"=>113.64861}}], "overallOfficials"=>[{"name"=>"Nieto Luis, Master", "role"=>"STUDY_CHAIR", "affiliation"=>"Site Coordinator of United Medical Group located in Miami"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Zeng Changhao", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR_INVESTIGATOR", "investigatorTitle"=>"Research Director", "investigatorFullName"=>"Zeng Changhao", "investigatorAffiliation"=>"People's Hospital of Zhengzhou University"}}}}
