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

Dysphagia, Oropharyngeal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06196606
• Other study ID #: 2024-KY-0297-002
• Status: Recruiting
• Phase: N/A
• Start date: November 11, 2022
• Est. completion date: December 12, 2024

Study information

• Verified date: May 2024
• Source: The First Affiliated Hospital of Zhengzhou University
• Contact: Yuli Zhu, postgraduate
• Phone: +8615351370521
• Email: 15351370521[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Under the ultrasound combined with balloon fixation, two injection sites were selected from the left upper esophageal sphincter, and 30U was injected respectively, and one injection site was selected from the right side, and 30U was injected. In addition, the patient also received routine swallowing training once a day for 30 minutes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 12, 2024
• Est. primary completion date: December 12, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Stem Infarctions
• Deglutition Disorders
• Dysphagia, Esophageal
• Dysphagia, Oropharyngeal
• Infarction

Intervention

Drug:
• Botulinum toxin type A for injection
Botulinum toxin was injected into the upper esophageal sphincter of each patient

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Zhengzhou University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Oral Intake Scale	According to whether the patient can eat by mouth and the degree of dependence on nasal feeding tube, it is divided into 7 grades, corresponding to 1-7 points respectively. The higher the score, the better the swallowing function.	day 1 ,day 14,day28 and day 180
Primary	Rosenbek penetration-aspiration scale	Based on the results of Videofluroscopic swallowing study (VFSS), the cases of leakage and aspiration were divided into 8 grades, corresponding to 1-8 points respectively. The higher the score, the better the swallowing function.	day 1 and day 14
Secondary	Murray secretion scale	Based on Fiberoptic endoscopic evaluation of swallowing (FEES), the accumulation position of oropharyngeal secretions was described and divided into 4 grades. The higher the score, the worse the swallowing function.	day 1 and day 14
Secondary	yale pharyngeal residue severity rating scale	Based on Fiberoptic endoscopic evaluation of swallowing (FEES), the main indicators include the location of the residue (epiglottic valley and pyriform sinus) and the amount of residue, which is divided into 5 grades. The higher the score, the worse the swallowing function.	day 1 and day 14
Secondary	fiberoptic endoscopic dysphagia severity scale	Based on Fiberoptic endoscopic evaluation of swallowing (FEES), Eat different foods and observe whether penetration aspiration and protective reflex occur. The highest score is 6, which means that saliva accumulates with penetration or aspiration, and the lowest score is 1. When eating soft solid food, there is no leakage or aspiration, and there is little or moderate residue in epiglottic valley or pyriform sinus. The higher the score, the worse the swallowing function.	day 1 and day 14