Treatment of Dysphagia by Using a Synchronized Electrical Stimulation Device

Not Applicable

Completed

• Conditions: Deglutition Disorders
• Interventions: Device: Synchronized Electrical Stimulation Device

• Registration Number: NCT02718963
• Lead Sponsor: Seoul National University Hospital

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)"

Study Timeline

• Study Start: 2015-07-15
• Study First Submitted: 2016-03-20
• Study First Submitted QC: 2016-03-23
• Study First Posted: 2016-03-24
• Primary Completion: 2016-06-24
• Study Completion: 2016-06-24
• Results First Submitted: 2019-07-23
• Status Verified: 2020-10
• Results First Submitted QC: 2020-10-20
• Last Update Submitted: 2020-10-20
• Results First Posted: 2020-11-12
• Last Update Posted: 2020-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Synchronized Electrical Stimulation Device	* 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
Control group	Synchronized Electrical Stimulation Device	* 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

Primary Outcome Measures

Name	Time	Method
Pressure and Timing Change of Velopharynx, Tongue Base, Low Pharynx and Upper Esophageal Sphincter.	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).

Trial Locations

Locations (1)

Department of Rehabilitation Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of