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The Safety and Efficacy of the 4 Channel NMES on Swallowing

Dysphagia Clinical Trial

Official title:
A Double-blind, Parallel Cumulative Medical Device Pivotal Clinical Study to Assess the Safety and Efficacy of the 4 Channel NMES, Multi-center Prospective Study (Pilot Study)

Clinical Trial 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 4ch NMES and 2ch NMES, 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.

Clinical Trial 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 4channel or 2channel Neuromuscular Electrical Stimulation.

- Main outcome measures: videofluoroscopic parameters, EQ-5D (EuroQoL-5D) questionnaire, II. M. D Anderson dysphagia inventory ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03670498
Study type Interventional
Source Seoul National University Hospital
Contact
Status Completed
Phase N/A
Start date October 1, 2018
Completion date August 4, 2019
View Details
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