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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Dysphagia

Intervention / Treatment
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* Device: 4 channel Electrical Stimulation Device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Revised sequential activation protocol<br>Apply 4 channel electrical stimulation device with a revised sequential activation protocol. It sequentially activates Rt. suprahyoid m (ch 1), Lt. suprahyoid m (ch 2), thyrohyoid m (ch 3), sternothyroid m (ch 4) with 4 channel electrical stimulation device. | Device: 4 channel Electrical Stimulation Device<br>* electrical stimulation at muscles which related with deglutition<br>|
| No Intervention: control subject<br>Apply 4 channel electrical stimulation device without any stimulation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, cervical spinal cord injury