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

Seoul National University Hospital51 enrolled

Overview

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.

* 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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Dysphagia

Interventions

4 channel Electrical Stimulation DeviceDEVICE

electrical stimulation at muscles which related with deglutition

Eligibility

Sex: ALLMin age: 19 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Seoul national university bundang hospital

Seongnam-si, Bundang, South Korea

Outcomes

Primary Outcomes

total score 0 from 55, 55 is worst outcome

Time frame: Change from Baseline without stimulation at within 1 weeks with electrical stimulation applied

Data from ClinicalTrials.gov

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