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Completed

NCT Number: NCT02718963

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.

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Key information

Conditions

Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Rehabilitation Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine

Seongnam-si, Gyeonggi-do, 463-707, South Korea

About this study

  • 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)"

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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"

Treatment and study plan

Synchronized Electrical Stimulation Device

Device

electrical stimulation at muscles which related with deglutition

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 24, 2016
Registry last updated
Nov 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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