Cerebral Small Vessel Diseases Clinical Trial
Official title:
A Randomized Controlled Trial For Stellate Ganglion Block in Individuals With Cerebral Small Vessel Disease
NCT number | NCT06301711 |
Other study ID # | SGB-CVSD |
Secondary ID | |
Status | Not yet recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2024 |
Est. completion date | June 2024 |
This is a prospective study conducted on patients with Cerebral Small Vessel Disease, 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 Stellate Ganglion Block. 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.
Status | Not yet recruiting |
Enrollment | 80 |
Est. completion date | June 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age>18 years. - Meeting the diagnostic criteria for cerebral small vessel disease. - Dysphagia confirmed by Videofluoroscopic Swallowing Study - Mini-Mental State Examination (MMSE)<27, indicating the existence of cognitive impairment. - No history of prior stroke. Exclusion Criteria: - Dysphagia that might be caused by other diseases that might cause dysphagia, such as head and neck tumors, traumatic brain injury, myasthenia gravis, etc. - Cognitive impairment that might be caused by other diseases, such as Alzheimer's disease. - Neurological blockade contraindications such as bleeding tendency, blocked site infection. - Unable to successfully finish the assessment of this study. - Complicated with severe liver and kidney failure, tumors, or hematological disorders. - Simultaneously in need to undergo other therapy that might affect the outcomes of this study. - Pregnant or nursing females |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Ahmadu Bello University Teaching Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Penetration-Aspiration Scale | 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. | day 1 and day 10 | |
Secondary | Modified Barthel Index | 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. | day 1 and day 10 | |
Secondary | Mini-Mental State Examination | 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. | day 1 and day 10 | |
Secondary | Swallowing duration | The time duration that the patient swallowed the contrast agent under Videofluoroscopic Swallowing Study the was recorded.Unit: seconds. | day 1 and day 10 | |
Secondary | Functional Oral Intake Scale | 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. | day 1 and day 10 |
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