Nctid:
NCT06225076
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-01"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000083242", "term"=>"Ischemic Stroke"}, {"id"=>"D000010244", "term"=>"Bulbar Palsy, Progressive"}], "ancestors"=>[{"id"=>"D000009422", "term"=>"Nervous System Diseases"}, {"id"=>"D000020521", "term"=>"Stroke"}, {"id"=>"D000002561", "term"=>"Cerebrovascular Disorders"}, {"id"=>"D000001927", "term"=>"Brain Diseases"}, {"id"=>"D000002493", "term"=>"Central Nervous System Diseases"}, {"id"=>"D000014652", "term"=>"Vascular Diseases"}, {"id"=>"D000002318", "term"=>"Cardiovascular Diseases"}, {"id"=>"D000016472", "term"=>"Motor Neuron Disease"}, {"id"=>"D000019636", "term"=>"Neurodegenerative Diseases"}, {"id"=>"D000009468", "term"=>"Neuromuscular Diseases"}], "browseLeaves"=>[{"id"=>"M22306", "name"=>"Stroke", "relevance"=>"LOW"}, {"id"=>"M10543", "name"=>"Ischemia", "relevance"=>"LOW"}, {"id"=>"M25603", "name"=>"Ganglion Cysts", "relevance"=>"LOW"}, {"id"=>"M2400", "name"=>"Ischemic Stroke", "asFound"=>"Ischemic Stroke", "relevance"=>"HIGH"}, {"id"=>"M13157", "name"=>"Paralysis", "relevance"=>"LOW"}, {"id"=>"M16358", "name"=>"Synovial Cyst", "relevance"=>"LOW"}, {"id"=>"M13158", "name"=>"Bulbar Palsy, Progressive", "asFound"=>"Bulbar Palsy", "relevance"=>"HIGH"}, {"id"=>"M5810", "name"=>"Cerebrovascular Disorders", "relevance"=>"LOW"}, {"id"=>"M5204", "name"=>"Brain Diseases", "relevance"=>"LOW"}, {"id"=>"M5742", "name"=>"Central Nervous System Diseases", "relevance"=>"LOW"}, {"id"=>"M17400", "name"=>"Vascular Diseases", "relevance"=>"LOW"}, {"id"=>"M18879", "name"=>"Motor Neuron Disease", "relevance"=>"LOW"}, {"id"=>"M4024", "name"=>"Amyotrophic Lateral Sclerosis", "relevance"=>"LOW"}, {"id"=>"M21558", "name"=>"Neurodegenerative Diseases", "relevance"=>"LOW"}, {"id"=>"M12411", "name"=>"Neuromuscular Diseases", "relevance"=>"LOW"}, {"id"=>"T4723", "name"=>"Progressive Bulbar Palsy", "asFound"=>"Bulbar Palsy", "relevance"=>"HIGH"}, {"id"=>"T349", "name"=>"Amyotrophic Lateral Sclerosis", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Heart and Blood Diseases", "abbrev"=>"BC14"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}, {"name"=>"Nutritional and Metabolic Diseases", "abbrev"=>"BC18"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000008012", "term"=>"Lidocaine"}], "ancestors"=>[{"id"=>"D000000779", "term"=>"Anesthetics, Local"}, {"id"=>"D000000777", "term"=>"Anesthetics"}, {"id"=>"D000002492", "term"=>"Central Nervous System Depressants"}, {"id"=>"D000045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000018689", "term"=>"Sensory System Agents"}, {"id"=>"D000018373", "term"=>"Peripheral Nervous System Agents"}, {"id"=>"D000000889", "term"=>"Anti-Arrhythmia Agents"}, {"id"=>"D000061567", "term"=>"Voltage-Gated Sodium Channel Blockers"}, {"id"=>"D000026941", "term"=>"Sodium Channel Blockers"}, {"id"=>"D000049990", "term"=>"Membrane Transport Modulators"}, {"id"=>"D000045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}], "browseLeaves"=>[{"id"=>"M3777", "name"=>"Ethanol", "relevance"=>"LOW"}, {"id"=>"M11014", "name"=>"Lidocaine", "asFound"=>"Gait training", "relevance"=>"HIGH"}, {"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"=>"M4107", "name"=>"Anesthetics", "relevance"=>"LOW"}, {"id"=>"M4109", "name"=>"Anesthetics, Local", "relevance"=>"LOW"}, {"id"=>"M4213", "name"=>"Anti-Arrhythmia Agents", "relevance"=>"LOW"}, {"id"=>"M23177", "name"=>"Sodium Channel Blockers", "relevance"=>"LOW"}, {"id"=>"M30025", "name"=>"Diuretics, Potassium Sparing", "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-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Anti-Arrhythmia Agents", "abbrev"=>"AnArAg"}, {"name"=>"Channel Blockers", "abbrev"=>"ChanBlk"}, {"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"=>"2024-01-30", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-03", "completionDateStruct"=>{"date"=>"2024-05-30", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-03-02", "studyFirstSubmitDate"=>"2024-01-13", "studyFirstSubmitQcDate"=>"2024-01-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-03-05", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-04-15", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Penetration-Aspiration Scale", "timeFrame"=>"day 1 and day 20", "description"=>"On the day 1 and day 20, Penetration-Aspiration Scale was used to assess dysphagia under Videofluoroscopic Swallowing Study, primarily evaluating the extent to which fluid food entered the airway and caused penetration or aspiration during the swallowing process. As the level increased, the severity of dysphagia also increased."}], "secondaryOutcomes"=>[{"measure"=>"Functional Oral Intake Scale", "timeFrame"=>"day 1 and day 20", "description"=>"During Dysphagia-Functional Oral Intake Scale assessment, evaluators engage in communication with the patient, conduct observations, and make records to assess the patient's oral intake ability. The Functional Oral Intake Scale assessment form includes seven levels of scoring, ranging from level 1 to level 7, indicating a progressive improvement in the patient's oral intake ability. In general, the result below level 6 indicates unsafe for oral intake while level 6 and above indicates that eating via mouth can be safely conducted."}, {"measure"=>"Video Fluoroscopic Swallowing Study", "timeFrame"=>"day 1 and day 20", "description"=>"Video Fluoroscopic Swallowing Study, which is considered as the \"gold standard\", swallowing process is divided into four periods: cognitive, oral, pharyngeal, and esophageal periods with a total score of 10 and a higher score indicates better swallowing ability (less dysphagia)."}, {"measure"=>"Murray secretion severity scale", "timeFrame"=>"day 1 and day 20", "description"=>"Murray secretion severity scale is used for assessment of Pharyngeal secretion. The result was divided into 0-3 levels (0, normal; 1, a small amount of secretion remained and not entering the laryngeal vestibule; 2: temporary accumulation in the laryngeal vestibule; 3: persistent accumulation in the laryngeal vestibule. A higher score indicates the worse dysphagia."}, {"measure"=>"Yale pharyngeal residue severity rating scale", "timeFrame"=>"day 1 and day 20", "description"=>"The Yale pharyngeal residue severity rating scale was recruited for assessment of Pharyngeal residue.The result would be divided into 5 levels (1, no residue; 2, the covered pharyngeal mucosa; 3, mild residue, less than 50%; 4, moderate residue, more than 50%; 5, severe residue, spillage from laryngeal vestibule observed). A higher score indicates the worse dysphagia."}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Bulbar Palsy"]}, "descriptionModule"=>{"briefSummary"=>"This is a randomized controlled study, including dysphagic patients with bulbar palsy after ischemic stroke who were received in the department of rehabilitation medicine in 3 hospitals in China. All patients are randomly allocated to the observation group or the control group. Both groups are provided with comprehensive rehabilitation. Besides, the observation group additionally undergoes the stellate ganglion block. At admission and after 20-day treatment, video fluoroscopic swallowing study, and penetration-aspiration scale, Functional Oral Intake Scale, Flexible laryngoscope are used to assess swallowing function.", "detailedDescription"=>"Palliation of dysphagia in patients with bulbar palsy after ischemic stroke continues to be a challenge.This is a randomized controlled study, including dysphagic patients with bulbar palsy after ischemic stroke who were received in the department of rehabilitation medicine in 3 hospitals in China. All patients are randomly allocated to the observation group or the control group. Both groups are provided with comprehensive rehabilitation. Besides, the observation group additionally undergoes the stellate ganglion block. At admission and after 20-day treatment, video fluoroscopic swallowing study, and penetration-aspiration scale, Functional Oral Intake Scale, Flexible laryngoscope are used to assess swallowing function."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Diagnosed with ischemic stroke according to the diagnostic criteria, with the stroke occurring in the medulla oblongata and diagnosed as bulbar palsy.\n* Upper Esophageal Sphincter did not open or opened ineffectively, with food residue or aspiration, revealed by Videofluoroscopic Swallow Study.\n* Age \\>18 years.\n* First-time stroke.\n* Steady vital signs,\n* Transferred or admitted to the Department of Rehabilitation Medicine within 15d after onset.\n\nExclusion Criteria:\n\n* The bulbar palsy caused by other diseases, such as neurodegenerative diseases.\n* Pseudobulbar palsy.\n* Complicated with other neurological diseases.\n* Tracheostomy tube inserted.\n* Simultaneously suffering from liver, kidney failure, tumors, or hematological diseases.\n* Dysphagia caused by other possible diseases.\n* Pregnant females."}, "identificationModule"=>{"nctId"=>"NCT06225076", "briefTitle"=>"Efficacy of Stellate Ganglion Block in Dysphagic Patients With Bulbar Palsy After Ischemic Stroke", "organization"=>{"class"=>"OTHER", "fullName"=>"People's Hospital of Zhengzhou University"}, "officialTitle"=>"A Randomized Controlled Study to Explore the Effect of Stellate Ganglion Block in Dysphagic Patients With Bulbar Palsy After Ischemic Stroke", "orgStudyIdInfo"=>{"id"=>"2024-KY-0112"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"The observation group", "description"=>"Patients enrolled are firstly numbered for privacy with software and divided into the observation group and the control group with. Additionally, the staffs involved in assessment would not participate in the intervention of the study. The treatment lasts 20 days.", "interventionNames"=>["Behavioral: Comprehensive rehabilitation", "Procedure: Stellate ganglion block", "Drug: Lidocaine Hydrochloride"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"The control group", "description"=>"Patients enrolled are firstly numbered for privacy with software and divided into the observation group and the control group with. Additionally, the staffs involved in assessment would not participate in the intervention of the study. The treatment lasts 20 days.", "interventionNames"=>["Behavioral: Comprehensive rehabilitation"]}], "interventions"=>[{"name"=>"Comprehensive rehabilitation", "type"=>"BEHAVIORAL", "description"=>"All the participants are provided with the comprehensive rehabilitation (routine rehabilitation and swallowing function training). The routine rehabilitation included intervention for risk factors (blood pressure, blood lipids, blood glucose, smoking and alcohol restriction, exercise, etc.).\n\nRegrading swallowing function training, both groups are given swallowing function training, including 1) exercises of closure of the vocal folds, pharyngeal, and laryngeal muscles exercises, and respiratory muscle strength training, for 15 min each time and twice per day. 2) isotonic／isometric swallowing exercises, supraglottic swallowing exercises, for 20 min each time and twice per day. 3) effortful swallowing exercises, and cough reflex training, for 10 min each time and twice per day.", "armGroupLabels"=>["The control group", "The observation group"]}, {"name"=>"Stellate ganglion block", "type"=>"PROCEDURE", "description"=>"the patients in the observation 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 observation group"]}, {"name"=>"Lidocaine Hydrochloride", "type"=>"DRUG", "otherNames"=>["Injection"], "description"=>"the patients in the observation 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 observation group"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"450000", "city"=>"Zhengzhou", "state"=>"Henan", "country"=>"China", "facility"=>"Zheng Da First Hospital", "geoPoint"=>{"lat"=>34.75778, "lon"=>113.64861}}], "overallOfficials"=>[{"name"=>"Nieto Luis, Master", "role"=>"STUDY_DIRECTOR", "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"}}}}
