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 Details — Status: Completed

Administrative data

• NCT number: NCT03670498
• Other study ID #: E-1806/475-002
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: August 4, 2019

Study information

• Verified date: July 2020
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: August 4, 2019
• Est. primary completion date: August 4, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• patient who do not belong to the criteria excluded for subjects aged 19 years or older

• Patient who is confirmed to be dysphagia by videofluoroscopy

• Patients who need clinical application of electrical stimulation therapy equipment for dysphagia. ex) stroke, cervical spinal cord injury

• Those voluntarily agreeing to the clinical trial

Exclusion Criteria:

• Patient who refuse inspection, do not agree

• Simple "Commend obey", first step is impossible

• When instructions can not be executed due to dementia, psychiatric disorders, etc.

• Dysphagia occurs due to respiratory failure, neck surgery, etc.,

• Pregnant women and lactating women

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia

Intervention

Device:
• 4 channel Electrical Stimulation Device
electrical stimulation at muscles which related with deglutition
• 2 channel Electrical Stimulation Device
electrical stimulation at muscles which related with deglutition

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Kyungji-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	videofluoroscopic dysphagia scale	total score 100 from 0, 100 is worst outcome	baseline/ change from baseline when electrical stimulation applied(the object of this study is to know the temporary change of dysphagia when stimulating with 4ch NMES.