Ignite Creation Date:
2025-12-24 @ 9:10 PM
Ignite Modification Date:
2025-12-25 @ 7:00 PM
Study NCT ID:
NCT06176404
Status:
COMPLETED
Last Update Posted:
2024-08-28
First Post:
2023-12-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Stellate Ganglion Block in Patients With Cerebral Small Vessel Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Taiwan']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D059345', 'term': 'Cerebral Small Vessel Diseases'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], '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'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012046', 'term': 'Rehabilitation'}], 'ancestors': [{'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-26', 'studyFirstSubmitDate': '2023-12-11', 'studyFirstSubmitQcDate': '2023-12-11', 'lastUpdatePostDateStruct': {'date': '2024-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-05', 'type': 'ACTUAL'}}, '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': 'Modified Barthel Index', 'timeFrame': 'day 1 and day 20', 'description': 'On the day 1 and day 20, the activities of daily living of patients were assessed using the modified Barthel Index . The scale included 10 items such as feeding, bathing, walking, dressing. Each item was rated on a 4-point scale based on the level of assistance required, with a total score of 100 points. There was a positive correlation between activities of daily living and the final score.'}, {'measure': 'Mini-Mental State Examination', 'timeFrame': 'day 1 and day 20', 'description': 'On the day 1 and day 20, the cognitive function of patients was assessed using the Mini-Mental State Examination (MMSE). The MMSE evaluated five aspects, including orientation, memory, attention and calculation abilities, recall ability, and language skills, with a total score of 30 points. A MMSE score of less than 27 indicated cognitive impairment, with scores ≤9 indicating severe impairment, 10-20 indicating moderate impairment, and 21-26 indicating mild impairment.'}, {'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 was recorded.Unit: seconds.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dysphagia', 'Cerebral Small Vessel Diseases', 'Cognitive Impairment']}, 'referencesModule': {'references': [{'pmid': '39270205', 'type': 'DERIVED', 'citation': 'Zeng H, Zhao W, Fang L, Pan H, Huang S, Zeng X. Effect of Stellate Ganglion Block on Dysphagia and Cognitive Impairment in Cerebral Small Vessel Disease: A Randomized Controlled Study. J Speech Lang Hear Res. 2024 Oct 8;67(10):3660-3672. doi: 10.1044/2024_JSLHR-24-00145. Epub 2024 Sep 13.'}]}, 'descriptionModule': {'briefSummary': 'A prospective study was conducted on 84 CSVD patients with dysphagia and cognitive impairment. They were divided into the comparison group and observation group evenly. All the patients were provided with routine therapy, while the patients in the observation group were given SGB. The swallowing function, cognitive function and activities of daily living of the two groups of patients before and after treatment were evaluated by Penetration-Aspiration Scale, Mini-mental state examination and modified Barthel index.', 'detailedDescription': 'In order to observe the effect of stellate ganglion block (SGB) on swallowing function, cognitive function and activities of daily living in patients with cerebral small vessel disease (CSVD), A prospective study was conducted on 84 CSVD patients with dysphagia and cognitive impairment. They were divided into the comparison group and observation group evenly. All the patients were provided with routine therapy, while the patients in the observation group were given SGB. The swallowing function, cognitive function and activities of daily living of the two groups of patients before and after treatment were evaluated by Penetration-Aspiration Scale, Mini-mental state examination and modified Barthel index.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age\\>18 years.\n* Meeting the diagnostic criteria for cerebral small vessel disease Imaging proposed in 2013 by the international cerebral small vessel disease Expert Group, and the "Consensus on Diagnosis and Treatment of Cerebral Small Vessel Disease in China" in 2017.\n* Dysphagia confirmed by Videofluoroscopic Swallowing Study\n* Mini-Mental State Examination (MMSE)\\<27, indicating the existence of cognitive impairment.\n* No history of prior stroke.\n* Stable vital signs.\n\nExclusion Criteria:\n\n* Dysphagia that might be caused by other diseases that might cause dysphagia, such as head and neck tumors, traumatic brain injury, myasthenia gravis, etc.\n* Cognitive impairment that might be caused by other diseases, such as Alzheimer\'s disease, Parkinson\'s disease, brain injury, etc.\n* Neurological blockade contraindications such as bleeding tendency, blocked site infection.\n* MMSE\\<10, or unable to successfully finish the assessment of this study (Patients with severe mental illness or intellectual disability might have difficulty to cooperate with the assessment).\n* Complicated with severe liver and kidney failure, tumors, or hematological disorders.\n* Simultaneously in need to undergo other therapy that might affect the outcomes of this study.\n* Pregnant or nursing females.'}, 'identificationModule': {'nctId': 'NCT06176404', 'briefTitle': 'Stellate Ganglion Block in Patients With Cerebral Small Vessel Disease', 'organization': {'class': 'OTHER', 'fullName': "People's Hospital of Zhengzhou University"}, 'officialTitle': 'Stellate Ganglion Block in Cerebral Small Vessel Disease Patients With Dysphagia and Cognitive Impairment', 'orgStudyIdInfo': {'id': 'NXXG-SGB-jiu'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'The comparison 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\nParticularly, due to dysphagia, the patients enrolled might face difficulty in eating. For patients who were able to finish intake via mouth by compensatory means, the consistency, type, and size of food bolus was arranged. For those who cannot acquire sufficient nutrition through oral intake, the nasogastric tube feeding (NGT) was provided.', 'interventionNames': ['Behavioral: Rehabilitation therapy']}, {'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\nParticularly, due to dysphagia, the patients enrolled might face difficulty in eating. For patients who were able to finish intake via mouth by compensatory means, the consistency, type, and size of food bolus was arranged. For those who cannot acquire sufficient nutrition through oral intake, the nasogastric tube feeding (NGT) was provided.\n\nBased on the invention above, the patients in the observation group were provided with SGB, using 1.5ml of 2% Lidocaine hydrochloride (1ml: 0.5mg) and 500ug of Vitamin B12 (1ml: 0.5g).', 'interventionNames': ['Drug: Stellate ganglion block', 'Behavioral: Rehabilitation therapy']}], 'interventions': [{'name': 'Stellate ganglion block', 'type': 'DRUG', 'otherNames': ['SGB'], 'description': 'Based on the invention above, the patients in the observation group were provided with SGB, 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 SGB. 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': 'Rehabilitation therapy', 'type': 'BEHAVIORAL', 'otherNames': ['Rehabilitation Treatment'], '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\nParticularly, due to dysphagia, the patients enrolled might face difficulty in eating. For patients who were able to finish intake via mouth by compensatory means, the consistency, type, and size of food bolus was arranged. For those who cannot acquire sufficient nutrition through oral intake, the nasogastric tube feeding (NGT) was provided.', 'armGroupLabels': ['The comparison group', 'The observation group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Huabei', 'country': 'China', 'facility': 'Zhen Da No.1 Fushu Hos.', 'geoPoint': {'lat': 30.40072, 'lon': 105.2288}}], 'overallOfficials': [{'name': 'Nieto Luis, Master', 'role': 'PRINCIPAL_INVESTIGATOR', '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"}}}}