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Clinical Trials/NCT02718963
NCT02718963
Completed
Not Applicable

Treatment of Dysphagia by Using a Synchronized Electrical Stimulation Device

Seoul National University Hospital1 site in 1 country20 target enrollmentJuly 15, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Deglutition Disorders
Sponsor
Seoul National University Hospital
Enrollment
20
Locations
1
Primary Endpoint
Pressure and Timing Change of Velopharynx, Tongue Base, Low Pharynx and Upper Esophageal Sphincter.
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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

Detailed Description

* 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)"

Registry
clinicaltrials.gov
Start Date
July 15, 2015
End Date
June 24, 2016
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ju Seok Ryu

associate professor

Seoul National University Hospital

Eligibility Criteria

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"

Outcomes

Primary Outcomes

Pressure and Timing Change of Velopharynx, Tongue Base, Low Pharynx and Upper Esophageal Sphincter.

Time Frame: During the electrical stimulation and electrical stimulation effects of Velopharynx, tongue base, lower 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).

Study Sites (1)

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