Effect of Multifunctional Nutrition Tube on Cerebral Small Vessel Disease Patients (NCT06265857) | Clinical Trial Compass
UnknownNot Applicable
Effect of Multifunctional Nutrition Tube on Cerebral Small Vessel Disease Patients
Thailand88 participantsStarted 2024-02-28
Plain-language summary
Nasogastric tube feeding (NGT) has been widely used in cerebral small vessel disease (CSVD) patients with dysphagia but has a significant risk of complications. Intermittent Oro-esophageal Tube Feeding (IOE) is an established enteral nutrition approach that can be used with comprehensive rehabilitation therapy. This study aims to explore the clinical effect of IOE vs. NGT on CSVD Patients with Dysphagia. Compared to NGT, IOE, as an enteral nutrition support mode, in CSVD Patients with Dysphagia who received comprehensive rehabilitation therapy, showed advantages in improvement in dysphagia, nutritional status, ADL, QOL, pneumonia, and adverse events, which should be considered as the preferred approach.
Who can participate
Age range
40 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Clinical diagnosis of CSVD, confirmed by MRI;
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.