Treatment of Dysphagia by Using a Synchronized Electrical Stimulation Device

Deglutition Disorders Clinical Trial

Official title:

Treatment of Dysphagia by Using a Synchronized Electrical Stimulation Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02718963
• Other study ID #: B-1507/306-002
• Status: Completed
• Phase: N/A
• Start date: July 15, 2015
• Est. completion date: June 24, 2016

Study information

• Verified date: October 2020
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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)"

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 24, 2016
• Est. primary completion date: June 24, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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"

Related Conditions & MeSH terms

• Deglutition Disorders

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Department of Rehabilitation Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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