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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03670485

Enrollment

Registered

2018-09-13

Start date

2019-06-01

Completion date

2020-02-21

Last updated

2020-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysphagia

Keywords

stroke, cervical spinal cord injury

Brief 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.

Detailed 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

Interventions

DEVICE4 channel Electrical Stimulation Device

electrical stimulation at muscles which related with deglutition

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026