NCT05483582

Clinical Trial for Clinical Excellence and Safety Evaluation of 4-channel Functional Electric Stimulator

Clinical Trial to Evaluate the Efficacy and Safety of a 4-channel Swallowing Function Electrical Stimulation Device Compared to a 2-channel Swallowing Function Electrical Stimulation Device for the Rehabilitation Mechanism

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years – 90 Years
• Healthy volunteers: Accepted

Summary

This study is a pilot study to prepare clinical trials to evaluate the safety and effectiveness of 4-channel electric stimulation therapy devices as a newly developed function for the treatment of dysphagia disorders. The purpose of this study is to investigate the difference in effect by the electric stimulation method and to obtain the values such as mean, standard deviation and so on, and to determine the number of subjects to be studied for clinical trials of validation permission in the future.

Detailed description

* Design: Prospective study * Inclusion criteria of patient group: who has a dysphagia symptom and confirmed by video-fluoroscopic swallowing study * Intervention: Participants are divided into two group and applied electrical stimulation by a "Synchronized Electrical Stimulation Device(SESD)" in different protocol * Main outcome measures: Videofluoroscopic Dysphagia Scale (VDS), Penetration aspiration scale (PAS), Measured by kinematic metaphysical analysis. The dietary status of the subjects was evaluated by the Functional Oral Intake Scale (FOIS), and the M.D Anderson dysphagia inventory was used to measure the diet-related quality of life. The Likert scale is used to evaluate the satisfaction with the application of the electric stimulation therapy device of the study subjects. * Secondary outcome measures: Verifying the safety of functional electric stimulation therapy device for dysphagia, measuring the effect on Tongue Strength through IOPI, the effect on changes in body composition through Bioelectrical Impedance Analysis (BIA; InBody S10, InBody, Inc.), and whether there is a significant change in actual patient intake and nutritional status through oral intake survey and MNA-SF measure. An exploratory comparison of intervention effects over time between 2-week and 4-week interventions.

Conditions

• Dysphagia

Interventions

Type	Name	Description
DEVICE	4-channel Electrical Stimulation Device	electrical stimulation at muscles which related with deglutition
DEVICE	2-channel Electrical Stimulation Device	electrical stimulation at muscles which related with deglutition

Timeline

• Start date: 2023-09-01
• Primary completion: 2024-12-31
• Completion: 2025-12-31
• First posted: 2022-08-02
• Last updated: 2024-04-22

Locations

1 site across 1 country: South Korea