Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT06196606

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

Led by The First Affiliated Hospital of Zhengzhou University · Updated on 2024-05-14

20

Participants Needed

1

Research Sites

108 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • MRI examination confirmed medullary infarction
  • No significant improvement in swallowing function after standardized rehabilitation for more than 2 weeks (FOIS unchanged or decreased)
  • Video-fluoroscopic swallowing study shows incomplete or no opening of the cricopharyngeal muscle
  • Fiberoptic endoscopic evaluation shows the hyoid bone moves upward more than half the height of the C3 vertebra
  • Stable vital signs
  • Patient or family voluntarily signed informed consent
Not Eligible

You will not qualify if you...

  • Brain MRI shows lesions outside the medulla oblongata
  • History of previous stroke
  • Severe cognitive impairment, mental illness, or severe cardiopulmonary disease
  • Abnormal throat structure
  • Malignant tumor
  • Other neuromuscular diseases
  • Infection or wound at injection site
  • Allergy to botulinum toxin
  • Bleeding tendency or coagulation dysfunction

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

Actively Recruiting

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Research Team

Y

Yuli Zhu, postgraduate

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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