Treatment of Dysphagia by Using a Synchronized Electrical Stimulation Device

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 24, 2016

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)"

Interventions

  • Device: Synchronized Electrical Stimulation Device
    • electrical stimulation at muscles which related with deglutition

Arms, Groups and Cohorts

  • Experimental: Control group
    • 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
  • Experimental: Experimental group
    • 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

Clinical Trial Outcome Measures

Primary Measures

  • 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).

Participating in This Clinical Trial

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"

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Seoul National University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ju Seok Ryu, associate professor – Seoul National University Hospital
  • Overall Official(s)
    • Jusuk Ryu, M.D. PhD, Study Director, Seoul National University Bundang Hospital

Citations Reporting on Results

Park D, Suh JH, Kim H, Ryu JS. The Effect of Four-Channel Neuromuscular Electrical Stimulation on Swallowing Kinematics and Pressures: A Pilot Study. Am J Phys Med Rehabil. 2019 Dec;98(12):1051-1059. doi: 10.1097/PHM.0000000000001241.

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