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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03670498
Other study ID # E-1806/475-002
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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.
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