An interventional study of Botulinum toxin type A for injection in Brain Stem Infarctions, Dysphagia, Oropharyngeal and Dysphagia, Esophageal, sponsored by The First Affiliated Hospital of Zhengzhou University. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-05-14.
Sponsored by The First Affiliated Hospital of Zhengzhou University · Not applicable, Interventional, and Treatment
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.
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.
27 studies on the registry are indexed under Brain Stem Infarctions; 20 are open to participants now.
This study's planned enrollment of 20 is above the median of 6 across 22 interventional studies indexed under Brain Stem Infarctions.
Browse Brain Stem Infarctions studies →The First Affiliated Hospital of Zhengzhou University is the lead sponsor of 126 studies on the registry; 73 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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)
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.
Time frame: 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.
Time frame: day 1 and day 14
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.
Time frame: day 1 and day 14
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.
Time frame: day 1 and day 14
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.
Time frame: day 1 and day 14
Plan to share: No — Due to the privacy policy of the First Affiliated Hospital of Zhengzhou University, the data cannot be disclosed, but it can be obtained from the PI with an appropriate reason
No publications or documents are linked to this record.
Started Nov 2022 (actual). Primary completion is estimated for Dec 2024, 25 months after the start.
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Studies of the drug tested here: Botulinum toxin type A
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