Brain Stem InfarctionsNCT06196606
Effect of Botulinum Toxin Injection Into Upper Esophageal Sphincter in Patients With Medullary Infarction
A study testing Botulinum toxin type A for injection in people with Brain Stem Infarctions and Dysphagia, Oropharyngeal, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Brain Stem Infarctions, Dysphagia, Oropharyngeal, Dysphagia, Esophageal
- What is being tested?
- Botulinum toxin type A for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 11 Nov 2022to 12 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- Infection or wound at the injection site
- Botulinum toxin allergic person
- Hemorrhagic tendency and coagulation dysfunction
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
Yuli Zhu, postgraduate, +8615351370521, 15351370521@163.com
Yuli Zhu, postgraduate
About this study
Official title: Effect of Botulinum Toxin Injection Into Upper Esophageal Sphincter on Swallowing Function in Patients With Medullary Infarction
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.
Read the 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.
- Being tested
- Botulinum toxin type A for injection
- Keywords
- Botulinum Toxins, Esophageal Sphincter, Upper
- Medical subject headings
- Brain Stem Infarctions, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin type A for injectionDrug
Also called Botulinum toxin type A for injection (Hengli National Drug approval number S10970037)
Botulinum toxin was injected into the upper esophageal sphincter of each patient
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Botulinum toxin type A for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: day 1 and day 14
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: day 1 and day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start11 Nov 2022
- Primary completion12 Dec 2024 (estimated)
- Study completion12 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Stem InfarctionsStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Zhengzhou UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuli Zhu, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06196606
- Sponsor's protocol ID
- 2024-KY-0297-002
- Status last verified
- May 2024
- First submitted
- 22 Dec 2023
- Last updated
- 14 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Botulinum Toxin Injection Into Upper Esophageal Sphincter on Swallowing Function in Patients With Medullary Infarction
- ClinicalTrials.gov ID
- NCT06196606
- Acronym / sponsor ID
- 2024-KY-0297-002
- Keywords
- Botulinum Toxins, Esophageal Sphincter, Upper
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Study start
- 11 Nov 2022 (actual)
- Primary completion
- 12 Dec 2024 (estimated)
- Study completion
- 12 Dec 2024 (estimated)
- First posted
- 9 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Drug: Botulinum toxin type A for injectionBotulinum 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum toxin type A for injectionAlso: Botulinum toxin type A for injection (Hengli National Drug approval number S10970037)Botulinum toxin was injected into the upper esophageal sphincter of each patient | Drug | experimental group |
Primary outcome
Functional Oral Intake Scale
Time frame: day 1 ，day 14，day28 and day 180
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.
Rosenbek penetration-aspiration scale
Time frame: day 1 and day 14
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.
3 secondary outcomes
Murray secretion scale
Time frame: day 1 and day 14
yale pharyngeal residue severity rating scale
Time frame: day 1 and day 14
fiberoptic endoscopic dysphagia severity scale
Time frame: day 1 and day 14
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botulinum toxin type A for injection in people with Brain Stem Infarctions and Dysphagia, Oropharyngeal, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuli Zhu, postgraduate (+8615351370521, 15351370521@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Oral Intake Scale (time frame: day 1 ，day 14，day28 and day 180). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.