Effect of Botulinum Toxin Injection Into Upper Esophageal Sphincter in Patients With Medullary Infarction

• Status: Recruiting
• Trial end date: 2024-12-12
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital of Zhengzhou University
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A

Criteria

Inclusion Criteria:

• MRI examination of the head confirmed the medullary infarction.

• Those who have not significantly improved swallowing function after standardized rehabilitation treatment for more than 2 weeks (FOIS remains unchanged or decreases)

• Video-fluroscopic swallowing study (VFSS) indicated incomplete/non-opening of the cricopharyngeal muscle

• Based on Fiberoptic endoscopic evaluation of swallowing, the hyoid bone moves upward more than half the height of the C3 cone

• Vital signs are stable

• The patient himself or his family voluntarily signed a written informed consent form.

Exclusion Criteria:

• Brain MRI showed that there were lesions in other areas outside the medulla oblongata

• People who have suffered from stroke in the past

• Patients with severe cognitive impairment, mental illness and severe cardiopulmonary disease

• Abnormal throat structure

• Malignant tumor patient

• Patients with other neuromuscular diseases

• Infection or wound at the injection site

• Botulinum toxin allergic person

• Hemorrhagic tendency and coagulation dysfunction