Botulinum toxin injection for swallowing difficulties after brain stem infarction
Effect of Botulinum Toxin Injection Into Upper Esophageal Sphincter on Swallowing Function in Patients With Medullary Infarction
This study is testing if botulinum toxin injections can help people with swallowing difficulties after a brain stem stroke feel better and eat more easily.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital of Zhengzhou University Academic / other |
| Locations | 1 site (Zhengzhou) |
| Trial ID | NCT06196606 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of botulinum toxin type A injections into the upper esophageal sphincter for patients suffering from dysphagia due to medullary infarction. The study involves ultrasound-guided injections at specific sites in the esophageal sphincter, combined with daily swallowing training. The aim is to improve swallowing function in patients who have not responded to standard rehabilitation treatments. By addressing the high incidence of swallowing disorders in this population, the trial seeks to enhance patient quality of life and nutritional status.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with medullary infarction who have persistent swallowing difficulties despite rehabilitation efforts.
Not a fit: Patients with lesions outside the medulla oblongata, severe cognitive impairment, or other significant health issues may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could significantly improve swallowing function and quality of life for patients with dysphagia due to medullary infarction.
How similar studies have performed: Other studies have explored botulinum toxin injections for similar swallowing disorders, showing promising results, though this specific application may be novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Zhengzhou
- The First Affiliated Hospital of Zhengzhou University — Zhengzhou, China (Recruiting)
Study contacts
- Study coordinator: Yuli Zhu, postgraduate
- Email: 15351370521@163.com
- Phone: +8615351370521
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.