Treatment of Dysphagia by Using a Synchronized Electrical Stimulation Device

Study Overview
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Brief Summary
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The purpose of this study is to determine the synchronized electrical stimulation device effective in the treatment of dysphagia.

Detailed Description
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Design: Prospective study Inclusion criteria of the patient group: who has a dysphagia symptom and confirmed by video-fluoroscopic swallowing study(N=10) Inclusion criteria of the control group: who does not have any dysphagia symptoms, and does not have any underlying disease(N=10) Setting: Hospital rehabilitation department Intervention: Participants are applied electrical stimulation by a Synchronized Electrical Stimulation Device(SESD)

Official Title
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Treatment of Dysphagia by Using a Synchronized Electrical Stimulation Device

Conditions
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Deglutition Disorders

Intervention / Treatment
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* Device: Synchronized Electrical Stimulation Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: who have dysphagia symptoms and verified deglutition disorder by video fluoro swallowing study Exclusion Criteria: who reject the checkup their deglutition function by high resolution manometry who reject apply Synchronized Electrical Stimulator

Ages Eligible for Study
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Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control group<br>control group(N=10): who does not have dysphagia symptom apply Synchronized Electrical Stimulation Device before apply the synchronized electrical stimulation device, we will evaluate the high resolution manometry for evaluation of deglutition function during apply the synchronized electrical stimulation device, we will evaluate the high resolution manometry for evaluation of deglutition function | Device: Synchronized Electrical Stimulation Device<br>* electrical stimulation at muscles which related with deglutition<br>|
| Experimental: Experimental group<br>experimental group(N=10): who have dysphagia symptoms apply Synchronized Electrical Stimulation Device before apply the synchronized electrical stimulation device, we will evaluate the high resolution manometry for evaluation of deglutition function during apply the synchronized electrical stimulation device, we will evaluate the high resolution manometry for evaluation of deglutition function | Device: Synchronized Electrical Stimulation Device<br>* electrical stimulation at muscles which related with deglutition<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pressure and Timing Change of Velopharynx, Tongue Base, Low Pharynx and Upper Esophageal Sphincter. | Maximal pressure, integral, rise time, and duration in the regions of VP and TB (the time interval over the VP and TB integral). The maximal pressure of low pharynx (LP) (C in supplementary 1), maximal pre-upper esophageal sphincter (UES) pressure (F in supplementary 1), maximal cricopharyngeus (CP) pressure (D in supplementary 1), minimal upper esophageal sphincter (UES) pressure, upper esophageal sphincter (UES) activity time (the interval between pre-upper esophageal sphincter (UES) peak and post-upper esophageal sphincter (UES) peak; G in supplementary 1), and nadir upper esophageal sphincter (UES) pressure duration in the region of upper esophageal sphincter (UES). | During the electrical stimulation and electrical stimulation effects of Velopharynx, tongue base, lower pharynx and upper esophageal sphincter |