To Assess the Safety and Efficacy of the 4 Channel NMES Compensatory Medical Device in Swallowing, Multicenter Study

Dysphagia Clinical Trial

Official title:

A Prospective Study of Compensatory Medical Device Pivotal Clinical Study to Assess the Safety and Efficacy of the 4 Channel NMES, Multicenter Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03670485
• Other study ID #: E-1806-475-001
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia

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