NCT03670498

The Safety and Efficacy of the 4 Channel NMES on Swallowing

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 19 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 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.

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 4channel or 2channel Neuromuscular Electrical Stimulation. * Main outcome measures: videofluoroscopic parameters, EQ-5D (EuroQoL-5D) questionnaire, II. M. D Anderson dysphagia inventory

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: 2018-10-01
• Primary completion: 2019-08-04
• Completion: 2019-08-04
• First posted: 2018-09-13
• Last updated: 2020-07-23

Locations

1 site across 1 country: South Korea