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Search / Trial NCT06328842

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.

Locations

Patients applied

0 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