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Assess the Safety and Efficacy of the 4 Channel NMES, Pilot Study

Dysphagia Clinical Trial

Official title:
A Double-blind, Parallel Compensatory Medical Device Pivotal Clinical Study to Assess the Safety and Efficacy of the 4 Channel Neuromuscular Electrical Stimulation (NMES), 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 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.

Clinical Trial Description

- Design: Prospective study

- Inclusion criteria of patient group: who has a dysphagia symptom and confirmed by video-fluoroscopic swallowing study(N=9)

- Intervention: Participants are divided into two group and applied electrical stimulation by a "Synchronized Electrical Stimulation Device(SESD)" in different protocol

- Main outcome measures: high-resolution manometry(HRM) parameters, videofluoroscopic parameters, EQ-5D (EuroQoL-5D) questionnaire ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03664479
Study type Interventional
Source Seoul National University Hospital
Contact
Status Terminated
Phase N/A
Start date March 1, 2018
Completion date June 1, 2018
View Details
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