Actively Recruiting
Effect of Botulinum Toxin Injection Into Upper Esophageal Sphincter in Patients With Medullary Infarction
Led by The First Affiliated Hospital of Zhengzhou University · Updated on 2024-05-14
20
Participants Needed
1
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Dysphagia is an important complication in patients with medullary infarction, the incidence rate is 57%-69%. Compared with other brain infarctions, the medulla oblongata involves multiple swallowing-related nerve nuclei, and the possibility of brain remodeling after injury is small. Dysphagia has become a prominent clinical problem in patients with medullary infarction, which can lead to malnutrition, decrease the quality of life of patients and affect the prognosis of the disease. Solving this clinical problem is particularly important for patients with medullary infarction. The incidence of UES opening disorder in patients with medullary infarction is as high as 80%, and the clinical problem of UES opening disorder is enthusiastically studied at home and abroad. At present, the intervention measures include balloon dilatation, surgical incision and botulinum toxin injection. Balloon dilatation is easy to cause mucosal edema and damage, and cricopharyngeal myotomy often has complications such as local infection, massive hemorrhage and local nerve injury. There is no significant difference between the success rate of UES botulinum toxin injection and surgical incision. Among the above measures, UES botulinum toxin injection has a good clinical application prospect, but the drug dosage and injection method are still not unified in clinic. In particular, how to accurately locate has become a hot topic in current research. On this basis, this study uses ultrasound combined with balloon localization to inject UES botulinum toxin and make clinical observation.
CONDITIONS
Official Title
Effect of Botulinum Toxin Injection Into Upper Esophageal Sphincter in Patients With Medullary Infarction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- MRI examination confirmed medullary infarction
- No significant improvement in swallowing function after standardized rehabilitation for more than 2 weeks (FOIS unchanged or decreased)
- Video-fluoroscopic swallowing study shows incomplete or no opening of the cricopharyngeal muscle
- Fiberoptic endoscopic evaluation shows the hyoid bone moves upward more than half the height of the C3 vertebra
- Stable vital signs
- Patient or family voluntarily signed informed consent
You will not qualify if you...
- Brain MRI shows lesions outside the medulla oblongata
- History of previous stroke
- Severe cognitive impairment, mental illness, or severe cardiopulmonary disease
- Abnormal throat structure
- Malignant tumor
- Other neuromuscular diseases
- Infection or wound at injection site
- Allergy to botulinum toxin
- Bleeding tendency or coagulation dysfunction
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Actively Recruiting
Research Team
Y
Yuli Zhu, postgraduate
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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