Clinical trial NCT06196606: Effect of Botulinum Toxin Injection Into Upper Esophageal Sphincter in Patients With Medullary Infarction
Official title: Effect of Botulinum Toxin Injection Into Upper Esophageal Sphincter on Swallowing Function in Patients With Medullary Infarction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Brain Stem Infarctions
Dysphagia, Oropharyngeal
Dysphagia, Esophageal
Keywords: Botulinum Toxins
Esophageal Sphincter, Upper
Lead sponsor: The First Affiliated Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2024-01-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Functional Oral Intake Scale
timeFrame: day 1 ，day 14，day28 and day 180
measure: Rosenbek penetration-aspiration scale
timeFrame: day 1 and day 14
Secondary outcomes:
measure: Murray secretion scale
timeFrame: day 1 and day 14
measure: yale pharyngeal residue severity rating scale
timeFrame: day 1 and day 14
measure: fiberoptic endoscopic dysphagia severity scale
timeFrame: day 1 and day 14
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
Study officials:
References: