Status:
RECRUITING
Effect of Botulinum Toxin Injection Into Upper Esophageal Sphincter in Patients With Medullary Infarction
Lead Sponsor:
The First Affiliated Hospital of Zhengzhou University
Conditions:
Brain Stem Infarctions
Dysphagia, Oropharyngeal
Eligibility:
All Genders
18-80 years
Phase:
NA
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-r...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 12 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06196606
Start Date
November 11 2022
End Date
December 12 2024
Last Update
May 14 2024
Active Locations (1)
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1
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China