Treatment of Dysphagia by Using a Synchronized Electrical Stimulation Device

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

Study Overview

• Status: Completed
• Conditions: Deglutition Disorders
• Intervention / Treatment: Device: Synchronized Electrical Stimulation Device

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)"

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
      • Department of Rehabilitation Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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"

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Study Director: Jusuk Ryu, M.D. PhD, Seoul National University Bundang Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2015
• Primary Completion (Actual): June 24, 2016
• Study Completion (Actual): June 24, 2016

Study Registration Dates

• First Submitted: March 20, 2016
• First Submitted That Met QC Criteria: March 23, 2016
• First Posted (Estimate): March 24, 2016

Study Record Updates

• Last Update Posted (Actual): November 12, 2020
• Last Update Submitted That Met QC Criteria: October 20, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Deglutition Disorders
• Other Study ID Numbers: B-1507/306-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No