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

NCT ID: NCT06196606

Last Updated: 2024-05-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-11
• Study Completion Date: 2024-12-12

Brief 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.

Detailed 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.

Conditions

Brain Stem Infarctions; Dysphagia, Oropharyngeal; Dysphagia, Esophageal

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Botulinum toxin type A for injection

Intervention Type: DRUG

Botulinum toxin was injected into the upper esophageal sphincter of each patient

Interventions

Botulinum toxin type A for injection

Botulinum toxin was injected into the upper esophageal sphincter of each patient

Intervention Type: DRUG

Other Intervention Names

Botulinum toxin type A for injection (Hengli National Drug approval number S10970037)

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role: lead

Responsible Party

Yuli Zhu

postgraduate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Yuli Zhu, postgraduate

Role: CONTACT

15351370521@163.com

+8615351370521

Facility Contacts

Yuli Zhu, postgraduate

Role: primary

15351370521@163.com

+8615351370521

Other Identifiers

2024-KY-0297-002

Identifier Type: -

Identifier Source: org_study_id