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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
The First Affiliated Hospital of Zhengzhou University
RECRUITING
Zhengzhou
Contact Information
Primary
Yuli Zhu, postgraduate
15351370521@163.com
+8615351370521
Time Frame
Start Date: 2022-11-11
Estimated Completion Date: 2024-12-12
Participants
Target number of participants: 20
Treatments
Experimental: experimental group
Botulinum toxin type A for injection (Hengli National Drug approval number S10970037) 100U, diluted with 1 ml.9% sodium chloride solution for reserve use.Each patient was injected with 90U
Related Therapeutic Areas
Sponsors
Leads: The First Affiliated Hospital of Zhengzhou University

This content was sourced from clinicaltrials.gov