A Randomized Controlled Trial For Stellate Ganglion Block in Individuals With Cerebral Small Vessel Disease
Overview
- Phase
- Not Applicable
- Intervention
- Rehabilitation therapy
- Conditions
- Cerebral Small Vessel Diseases
- Sponsor
- Ahmadu Bello University Teaching Hospital
- Enrollment
- 80
- Primary Endpoint
- Penetration-Aspiration Scale
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
This study is conducted for Exploration of Stellate Ganglion Block in Patients With Cerebral Small Vessel Disease. 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.
Investigators
Muhammad
Research Director
Ahmadu Bello University Teaching Hospital
Eligibility Criteria
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
Arms & Interventions
Rehabilitation therapy+Stellate ganglion block
The study lasted 10 days 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. 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).
Intervention: Rehabilitation therapy
Rehabilitation therapy+Stellate ganglion block
The study lasted 10 days 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. 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).
Intervention: Stellate ganglion block
Rehabilitation therapy+Stellate ganglion block
The study lasted 10 days 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. 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).
Intervention: Lidocaine Hydrochloride
Rehabilitation therapy
The study lasted 10 days 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.
Intervention: Rehabilitation therapy
Outcomes
Primary Outcomes
Penetration-Aspiration Scale
Time Frame: day 1 and day 10
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.
Secondary Outcomes
- Functional Oral Intake Scale(day 1 and day 10)
- Mini-Mental State Examination(day 1 and day 10)
- Modified Barthel Index(day 1 and day 10)
- Swallowing duration(day 1 and day 10)