Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2025-12-26 @ 12:43 AM
Study NCT ID:
NCT06189560
Status:
TERMINATED
Last Update Posted:
2024-03-05
First Post:
2023-11-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Stellate Ganglion Block: A Breakthrough Treatment for Post-Stroke Pharyngeal Dysphagia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-12-10', 'size': 312376, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-12-09T09:14', 'hasProtocol': True}, {'date': '2021-12-10', 'size': 151495, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-12-09T09:15', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'whyStopped': 'ethical issues', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-05-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-02', 'studyFirstSubmitDate': '2023-11-29', 'studyFirstSubmitQcDate': '2023-12-19', 'lastUpdatePostDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Video fluoroscopic swallowing study', 'timeFrame': 'day 1 and day 20', 'description': "The patient was required to take a sitting position with the head naturally upright. Under the guidance of the examiner, the patient first swallowed 5ml of iohexol solution (50ml:17.5g in iodine terms). If the patient exhibited aspiration, the test would stop. If not, the patient was instructed to swallow 10ml of iohexol solution mixed with breadcrumbs, and the patient's swallowing condition was observed with immediate measures ready to take for safety. Specially, the esophageal phase was not included in the study, because it was commonly regarded as an independent phase. The swallowing were divided into 3 phases in this assessment: Oral phase, Pharyngeal phase, and Aspiration, with maximum 3,3,4 points were given to each phase. The total score was calculated as the final result. The final score was positively correlated with the swallowing function."}], 'secondaryOutcomes': [{'measure': 'Kubota water swallowing test', 'timeFrame': 'day 1 and day 20', 'description': "During the test, patients were required to drink 30 ml of warm water. According to the situation, the swallowing function was rated from Level 1 (excellent) to Level 5 (poor). Specifically, Grade 1: The patient drank all the water at once without choking; Grade II: The patient drank all the water in two or more times without choking; Grade III: The patient drank all the water at once with choking; Grade IV: The patient drank all the water in two or more times with choking; Grade V: The patient exhibited difficulty drinking with frequent choking. Besides, we evaluated the efficacy as: 1) Recovery: The patient's symptoms of dysphagia disappear with grade 1 in the test. 2) Improvement: The patient shows improvement in dysphagia with the water the grade of the test improved. 3) Invalid: The patient's dysphagia deteriorates or did not improve, with the grade of the test not improved. (Overall effective rate = Recovery rate + Improvement rate)."}, {'measure': 'Rosenbek penetration-aspiration scale', 'timeFrame': 'day 1 and day 20', 'description': "Based on VFSS, this assessment evaluated the patient's swallowing of contrast medium and whether there was retention, penetration, and aspiration. It included multiple items, each with the corresponding criteria, Specifically, whether the swallowed material entered the airway, passed through or contacted the vocal cords, and whether the patient exhibited the corresponding ability to clear. There were 8 levels in the results, with higher levels indicating more severe aspiration."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stellate ganglion block', 'Pharyngeal Dysphagia', 'Stroke', 'Rehabilitation', 'Swallowing disorder'], 'conditions': ['Dysphagia', 'Stellate Ganglion Block']}, 'referencesModule': {'references': [{'pmid': '34487721', 'type': 'BACKGROUND', 'citation': 'GBD 2019 Stroke Collaborators. Global, regional, and national burden of stroke and its risk factors, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Neurol. 2021 Oct;20(10):795-820. doi: 10.1016/S1474-4422(21)00252-0. Epub 2021 Sep 3.'}, {'pmid': '2893149', 'type': 'BACKGROUND', 'citation': 'Gilman RH, Marquis GS, Miranda E, Vestegui M, Martinez H. Rapid reinfection by Giardia lamblia after treatment in a hyperendemic Third World community. Lancet. 1988 Feb 13;1(8581):343-5. doi: 10.1016/s0140-6736(88)91131-2.'}, {'pmid': '30602168', 'type': 'BACKGROUND', 'citation': 'Bejot Y, Bailly H, Graber M, Garnier L, Laville A, Dubourget L, Mielle N, Chevalier C, Durier J, Giroud M. Impact of the Ageing Population on the Burden of Stroke: The Dijon Stroke Registry. Neuroepidemiology. 2019;52(1-2):78-85. doi: 10.1159/000492820. Epub 2019 Jan 2.'}, {'pmid': '33136216', 'type': 'BACKGROUND', 'citation': 'Jones CA, Colletti CM, Ding MC. Post-stroke Dysphagia: Recent Insights and Unanswered Questions. Curr Neurol Neurosci Rep. 2020 Nov 2;20(12):61. doi: 10.1007/s11910-020-01081-z.'}, {'pmid': '35321149', 'type': 'BACKGROUND', 'citation': 'Zhang G, Li Z, Gu H, Zhang R, Meng X, Li H, Wang Y, Zhao X, Wang Y, Liu G; Chinese Stroke Center Alliance investigators. Dysphagia Management and Outcomes in Elderly Stroke Patients with Malnutrition Risk: Results from Chinese Stroke Center Alliance. Clin Interv Aging. 2022 Mar 17;17:295-308. doi: 10.2147/CIA.S346824. eCollection 2022.'}, {'pmid': '27543535', 'type': 'RESULT', 'citation': 'Doi S, Cho N, Obara T. Stellate ganglion block increases blood flow in the anastomotic artery after superficial temporal artery-middle cerebral artery bypass. Br J Anaesth. 2016 Sep;117(3):395-6. doi: 10.1093/bja/aew230. No abstract available.'}, {'pmid': '23616589', 'type': 'RESULT', 'citation': 'ter Laan M, van Dijk JM, Elting JW, Staal MJ, Absalom AR. Sympathetic regulation of cerebral blood flow in humans: a review. Br J Anaesth. 2013 Sep;111(3):361-7. doi: 10.1093/bja/aet122. Epub 2013 Apr 24.'}, {'pmid': '35142688', 'type': 'RESULT', 'citation': 'Li TT, Wan Q, Zhang X, Xiao Y, Sun LY, Zhang YR, Liu XN, Yang WC. Stellate ganglion block reduces inflammation and improves neurological function in diabetic rats during ischemic stroke. Neural Regen Res. 2022 Sep;17(9):1991-1997. doi: 10.4103/1673-5374.335162.'}]}, 'descriptionModule': {'briefSummary': 'This was a multicenter randomized controlled study. 66 post-stroke patients with pharyngeal dysphagia were randomly allocated to the observation group (n=33) or the control group (n=33). Both groups were provided with comprehensive rehabilitation including routine rehabilitation and swallowing function training. Besides, the observation group additionally underwent the stellate ganglion block (SGB). At admission and after 20-day treatment, Kubota water swallowing test, video fluoroscopic swallowing study (VFSS), and Rosenbek penetration-aspiration scale (PAS) were used to assess swallowing function.', 'detailedDescription': 'Dysphagia is a frequent and potentially serious complication of stroke. However, there is no effective measure for the treatment of pharyngeal dysphagia in stroke patients. This study aims to explore the efficacy of stellate ganglion block in post-stroke pharyngeal dysphagic patients who received comprehensive rehabilitation. This was a multicenter randomized controlled study. 66 post-stroke patients with pharyngeal dysphagia were randomly allocated to the observation group (n=33) or the control group (n=33). Both groups were provided with comprehensive rehabilitation including routine rehabilitation and swallowing function training. Besides, the observation group additionally underwent the stellate ganglion block (SGB). At admission and after 20-day treatment, Kubota water swallowing test, video fluoroscopic swallowing study (VFSS), and Rosenbek penetration-aspiration scale (PAS) were used to assess swallowing function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 30 and 80 years;\n* New-onset stroke, confirmed by head CT or MRI;\n* The course of disease between 1 to 6 months;\n* With pharyngeal dysphagia shown by VFSS;\n* Stable vital signs;\n* Voluntary participation in the study.\n\nExclusion Criteria:\n\n* Allergy to Lidocaine injection or vitamin B12 injection;\n* Severe cognitive impairment;\n* Coagulation disorders;\n* Severe dysfunction of organs including heart, lungs, kidney, liver, etc.;\n* Complicated with other neurological diseases;\n* With severe oral dysphagia (results of the VFSS oral phase as 2 or 3 points);\n* Dysphagia caused by other diseases or reasons.'}, 'identificationModule': {'nctId': 'NCT06189560', 'acronym': 'SGB', 'briefTitle': 'Stellate Ganglion Block: A Breakthrough Treatment for Post-Stroke Pharyngeal Dysphagia', 'organization': {'class': 'OTHER', 'fullName': "People's Hospital of Zhengzhou University"}, 'officialTitle': 'A Random Controlled Study to Explore the Effect of Stellate Ganglion Block on Post-Stroke Pharyngeal Dysphagia', 'orgStudyIdInfo': {'id': '2022-KY-0049-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'The observation group', 'description': 'Patients enrolled were firstly numbered for privacy with software and divided into the observation group (n=33) and the control group (n=33) with a random number table. Additionally, the staffs involved in assessment would not participate in the intervention of the study. The treatment lasted 20 days.', 'interventionNames': ['Behavioral: comprehensive rehabilitation', 'Drug: SGB']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'The control group', 'description': 'Patients enrolled were firstly numbered for privacy with software and divided into the observation group (n=33) and the control group (n=33) with a random number table. Additionally, the staffs involved in assessment would not participate in the intervention of the study. The treatment lasted 20 days.', 'interventionNames': ['Behavioral: comprehensive rehabilitation']}], 'interventions': [{'name': 'comprehensive rehabilitation', 'type': 'BEHAVIORAL', 'description': 'All the participants were 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.) and pharmacological treatment (aspirin, statins, anticoagulants, etc.).\n\nRegrading swallowing function training, both groups were 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, and the Mendelsohn maneuver, 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': 'SGB', 'type': 'DRUG', 'description': 'the observation group was given SGB once a day, with 10 sessions as a course of treatment and each side of the body for one course. All the materials included: 1) 1.5ml of 2% Lidocaine hydrochloride injection (1ml: 0.5mg), Vitamin B12 Injection 500ug (1ml: 0.5g), the 5 ml disposable syringe and the sterile disposable dental injection needles. The specific operation procedure was as follows\\[16\\]: The operator stood at the patient\\'s block side, and the patient was placed in the supine position, with the head leaning 45 degrees toward the contralateral side of the block side. After routine disinfection of the skin, a paratracheal approach was adopted, which was, 2.5cm above the sternoclavicular joint and 1.5cm outside the midline of the neck.', 'armGroupLabels': ['The observation group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '450000', 'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'facility': 'Zheng da yi fu 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', 'description': "The datasets generated and analyzed during the current study are not publicly available due to the hospital's confidentiality regulations regarding trial data but are available from the corresponding author on reasonable request."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zeng Changhao', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'Zeng Changhao', 'investigatorAffiliation': "People's Hospital of Zhengzhou University"}}}}