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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03670485
Other study ID # E-1806-475-001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2019
Est. completion date February 21, 2020

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 confirmation 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 validate the 4ch NMES device.


Description:

- Design: Prospective study

- Inclusion criteria of patient group: who has a dysphagia symptom and confirmed by video-fluoroscopic swallowing study

- Intervention: applied electrical stimulation by a "Synchronized Electrical Stimulation Device(SESD)"

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


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date February 21, 2020
Est. primary completion date February 21, 2020
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

Locations

Country Name City State
Korea, Republic of Seoul national university bundang hospital Seongnam-si Bundang

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 The Modified Barium Swallow Impairment Profile (MBSImP™©) total score 0 from 55, 55 is worst outcome Change from Baseline without stimulation at within 1 weeks with electrical stimulation applied
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