Back to resultsTreatment of Dysphagia by Using a Synchronized Electrical Stimulation Device
Primary Purpose
Deglutition Disorders
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Synchronized Electrical Stimulation Device
Sponsored by
About this trial
This is an interventional treatment trial for Deglutition Disorders
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"
Sites / Locations
- Department of Rehabilitation Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Control group
Experimental group
Arm Description
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 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
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT02718963
First Posted
March 20, 2016
Last Updated
October 20, 2020
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02718963
Brief Title
Treatment of Dysphagia by Using a Synchronized Electrical Stimulation Device
Official Title
Treatment of Dysphagia by Using a Synchronized Electrical Stimulation Device
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
July 15, 2015 (Actual)
Primary Completion Date
June 24, 2016 (Actual)
Study Completion Date
June 24, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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)"
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deglutition Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Experimental
Arm Description
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
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Synchronized Electrical Stimulation Device
Intervention Description
electrical stimulation at muscles which related with deglutition
Primary Outcome Measure Information:
Title
Pressure and Timing Change of Velopharynx, Tongue Base, Low Pharynx and Upper Esophageal Sphincter.
Description
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).
Time Frame
During the electrical stimulation and electrical stimulation effects of Velopharynx, tongue base, lower pharynx and upper esophageal sphincter
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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"
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jusuk Ryu, M.D. PhD
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Department of Rehabilitation Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31180928
Citation
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.
Results Reference
result
Learn more about this trial
Treatment of Dysphagia by Using a Synchronized Electrical Stimulation Device
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