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

NCT06196606 | Recruiting

• 1 other identifier: 2024-KY-0297-002
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Stem Infarctions; Dysphagia, Oropharyngeal; Dysphagia, Esophageal

Keywords

Botulinum Toxins; Esophageal Sphincter, Upper

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Murray secretion scale

  day 1 and day 14

• yale pharyngeal residue severity rating scale

  day 1 and day 14

• fiberoptic endoscopic dysphagia severity scale

  day 1 and day 14

Study Arms (1)

experimental group

EXPERIMENTAL

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

Drug: Botulinum toxin type A for injection

Interventions

Botulinum toxin type A for injection DRUG

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

Also known as: Botulinum toxin type A for injection (Hengli National Drug approval number S10970037)

experimental group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University: lead

Study Sites (1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

RECRUITING

MeSH Terms

Conditions

Brain Stem Infarctions; Deglutition Disorders

Interventions

Botulinum Toxins, Type A; Injections

Condition Hierarchy (Ancestors)

Brain Infarction; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Vascular Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Yuli Zhu, postgraduate

CONTACT

+8615351370521; 15351370521@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: postgraduate

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: January 9, 2024
• Study Start: November 11, 2022
• Primary Completion: December 12, 2024
• Study Completion: December 12, 2024
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)