Nctid:
NCT06228170
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-03"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000001930", "term"=>"Brain Injuries"}, {"id"=>"D000070642", "term"=>"Brain Injuries, Traumatic"}, {"id"=>"D000014947", "term"=>"Wounds and Injuries"}], "ancestors"=>[{"id"=>"D000001927", "term"=>"Brain Diseases"}, {"id"=>"D000002493", "term"=>"Central Nervous System Diseases"}, {"id"=>"D000009422", "term"=>"Nervous System Diseases"}, {"id"=>"D000006259", "term"=>"Craniocerebral Trauma"}, {"id"=>"D000020196", "term"=>"Trauma, Nervous System"}], "browseLeaves"=>[{"id"=>"M5207", "name"=>"Brain Injuries", "asFound"=>"Brain Injury", "relevance"=>"HIGH"}, {"id"=>"M25603", "name"=>"Ganglion Cysts", "relevance"=>"LOW"}, {"id"=>"M628", "name"=>"Brain Injuries, Traumatic", "asFound"=>"Traumatic Brain Injury", "relevance"=>"HIGH"}, {"id"=>"M16358", "name"=>"Synovial Cyst", "relevance"=>"LOW"}, {"id"=>"M17685", "name"=>"Wounds and Injuries", "asFound"=>"Injury", "relevance"=>"HIGH"}, {"id"=>"M5204", "name"=>"Brain Diseases", "relevance"=>"LOW"}, {"id"=>"M5742", "name"=>"Central Nervous System Diseases", "relevance"=>"LOW"}, {"id"=>"M9349", "name"=>"Craniocerebral Trauma", "relevance"=>"LOW"}, {"id"=>"M22023", "name"=>"Trauma, Nervous System", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Wounds and Injuries", "abbrev"=>"BC26"}, {"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"=>"2024-01-30", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-03", "completionDateStruct"=>{"date"=>"2024-05-30", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-03-02", "studyFirstSubmitDate"=>"2024-01-19", "studyFirstSubmitQcDate"=>"2024-01-19", "lastUpdatePostDateStruct"=>{"date"=>"2024-03-06", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-29", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-04-30", "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 is used to assess dysphagia under Videofluoroscopic Swallowing Study, primarily evaluating the extent to which fluid food enter the airway and caused penetration or aspiration during the swallowing process. As the level increases, the severity of dysphagia also increases."}], "secondaryOutcomes"=>[{"measure"=>"Modified Barthel Index", "timeFrame"=>"day 1 and day 20", "description"=>"On the day 1 and day 20, the activities of daily living of patients will be assessed using the modified Barthel Index . The scale includes 10 items such as feeding, bathing, walking, dressing. Each item is rated on a 4-point scale based on the level of assistance required, with a total score of 100 points. There is a positive correlation between activities of daily living and the final score."}, {"measure"=>"Swallowing duration", "timeFrame"=>"day 1 and day 20", "description"=>"The time duration that the patient swallowed the contrast agent under Videofluoroscopic Swallowing Study the is recorded.Unit: seconds."}, {"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."}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Traumatic Brain Injury"]}, "descriptionModule"=>{"briefSummary"=>"The goal of this or clinical trial is to explore efficacy of stellate ganglion block on dysphagia and activities of daily living in Traumatic Brain Injury Patients. The main question it aims to answer are:\n\nCan stellate ganglion block improve the dysphagia and activities of daily living in Traumatic Brain Injury Patients.\n\nTraumatic Brain Injury Patients will be divided into the the control group and observation group evenly. All the patients were provided with routine therapy, while the patients in the observation group were given stellate ganglion block. The swallowing function, and activities of daily living of the two groups of patients before and after treatment were evaluated.", "detailedDescription"=>"Dysphagia, or swallowing difficulty, is a common symptom in Traumatic Brain Injury Patients. The goal of this or clinical trial is to explore efficacy of stellate ganglion block on dysphagia and activities of daily living in Traumatic Brain Injury Patients. The main question it aims to answer are:\n\nCan stellate ganglion block improve the dysphagia and activities of daily living in Traumatic Brain Injury Patients.\n\nTraumatic Brain Injury Patients will be divided into the the control group and observation group evenly. All the patients were provided with routine therapy, while the patients in the observation group were given stellate ganglion block. The swallowing function, and activities of daily living of the two groups of patients before and after treatment were evaluated."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* age ≥ 18 years, meeting the diagnosis of Traumatic Brain Injury;\n* presence of no contraindication for Stellate Ganglion Block;\n* with stable vital signs and no severe liver or kidney dysfunction, metabolic disorders, cardiovascular diseases, or multiple complications;\n* informed consent form was obtained from the patient\\'s family members, indicating their full understanding of the study and agreement to participate.\n\nExclusion Criteria:\n\n* unable to cooperate in completing treatment and assessment due to personal reasons or other disorders;\n* complicated with other intracranial lesions, such as stroke;\n* with severe consciousness disorders caused by other diseases."}, "identificationModule"=>{"nctId"=>"NCT06228170", "acronym"=>"SGB-TBI", "briefTitle"=>"Efficacy of Stellate Ganglion Block in Traumatic Brain Injury Patients", "organization"=>{"class"=>"OTHER", "fullName"=>"People's Hospital of Zhengzhou University"}, "officialTitle"=>"A Randomized Controlled Study to Explore the Efficacy of Stellate Ganglion Block in Traumatic Brain Injury Patients", "orgStudyIdInfo"=>{"id"=>"2024-KY-0119-002"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"The observation group", "description"=>"The study lasted 20d for each patient. During the treatment, All the participants were provided with the rehabilitation therapy, which included routine rehabilitation, cognitive training, swallowing function training and nutrition support.\n\nBased on the invention above, 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)", "interventionNames"=>["Behavioral: Rehabilitation therapy", "Procedure: Stellate ganglion block"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"The control group", "description"=>"The study lasted 20d for each patient. During the treatment, All the participants were provided with the rehabilitation therapy, which included routine rehabilitation, cognitive training, swallowing function training and nutrition support.", "interventionNames"=>["Behavioral: Rehabilitation therapy"]}], "interventions"=>[{"name"=>"Rehabilitation therapy", "type"=>"BEHAVIORAL", "description"=>"The study lasted 20d for each patient. During the treatment, All the participants were provided with the rehabilitation therapy, which included routine rehabilitation, cognitive training, swallowing function training and nutrition support.", "armGroupLabels"=>["The control group", "The observation group"]}, {"name"=>"Stellate ganglion block", "type"=>"PROCEDURE", "description"=>"Based on the invention above, 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 yi Yuan 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"}}}}
