Effect of Multifunctional Nutrition Tube on Cerebral Small Vessel Disease Patients
Launched by COPKA SONPASHAN · Mar 18, 2024
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new way to provide nutrition for patients with cerebral small vessel disease (CSVD) who have difficulty swallowing, a condition known as dysphagia. The trial will compare two methods of feeding: the traditional nasogastric tube (NGT) and a newer method called intermittent oro-esophageal tube feeding (IOE). The goal is to see if IOE can improve outcomes such as swallowing ability, nutrition, quality of life, and reduce the risk of pneumonia and other complications compared to NGT.
To be eligible for this study, participants need to be between 40 and 70 years old, have a clinical diagnosis of CSVD and dysphagia, and be able to cooperate with treatment and complete questionnaires. Importantly, they should not have a history of prior strokes or other serious health issues that could affect the study results. If eligible, participants will receive comprehensive rehabilitation therapy along with one of the feeding methods, and they will be monitored for improvements in their condition. This trial aims to help find the best approach for feeding patients with CSVD and dysphagia, ensuring safer and more effective care.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Clinical diagnosis of CSVD;
- • Must be able to cooperate with treatment and questionnaire investigation, (Generally with a Mini-Mental State Examination (MMSE) score ≥ 24) ;
- • Clinical diagnosis of dysphagia through the Functional Oral Intake Scale (FOIS) and Video Fluoroscopic Swallowing Study (VFSS);
- • Age between 40 and 70 years;
- • Enteral nutrition support was required and feasible.
- • No history of prior stroke.
- Exclusion Criteria:
- • Dysphagia related to other cerebrovascular diseases or caused by neurodegenerative diseases;
- • Complicated with severe liver and kidney failure, tumors, or hematological disorders;
- • Simultaneously need to undergo other therapy that might affect the outcomes of this study;
- • Pregnant or nursing females.
About Copka Sonpashan
Copka Sonpashan is a leading clinical trial sponsor dedicated to advancing innovative therapeutic solutions through rigorous research and development. With a focus on enhancing patient care, the organization specializes in designing and executing clinical trials across various therapeutic areas, ensuring compliance with regulatory standards and ethical guidelines. By fostering collaboration with healthcare professionals and leveraging cutting-edge technologies, Copka Sonpashan aims to expedite the drug development process while maintaining a steadfast commitment to patient safety and scientific integrity.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Trial Officials
Nieto Luis
Study Chair
Site Coordinator of United Medical Group
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported