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NCT Number: NCT03670498

The Safety and Efficacy of the 4 Channel NMES on Swallowing

This study is a pilot study to prepare clinical trials to evaluate the safety and effectiveness of 4-channel electric stimulation therapy devices as a newly developed function for the treatment of dysphagia disorders.

The purpose of this study is to investigate the difference in 4ch NMES and 2ch NMES, And to obtain the values such as mean, standard deviation and so on, and to determine the number of subjects to be studied for clinical trials of validation permission in the future.

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Key information

Conditions

Dysphagia Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Nervous System Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases Stroke Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Kyungji-do, 13620, South Korea

About this study

  • Design: Prospective study
  • Inclusion criteria of patient group: who has a dysphagia symptom and confirmed by video-fluoroscopic swallowing study
  • Intervention: Participants are divided into two group and applied electrical stimulation by a "Synchronized Electrical Stimulation Device(SESD)" in 4channel or 2channel Neuromuscular Electrical Stimulation.
  • Main outcome measures: videofluoroscopic parameters, EQ-5D (EuroQoL-5D) questionnaire, II. M. D Anderson dysphagia inventory

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • patient who do not belong to the criteria excluded for subjects aged 19 years or older
  • Patient who is confirmed to be dysphagia by videofluoroscopy
  • Patients who need clinical application of electrical stimulation therapy equipment for dysphagia. ex) stroke, cervical spinal cord injury
  • Those voluntarily agreeing to the clinical trial

Exclusion criteria

  • Patient who refuse inspection, do not agree
  • Simple "Commend obey", first step is impossible
  • When instructions can not be executed due to dementia, psychiatric disorders, etc.
  • Dysphagia occurs due to respiratory failure, neck surgery, etc.,
  • Pregnant women and lactating women

Treatment and study plan

4 channel Electrical Stimulation Device

Device

electrical stimulation at muscles which related with deglutition

2 channel Electrical Stimulation Device

Device

electrical stimulation at muscles which related with deglutition

Primary outcomes

  1. videofluoroscopic dysphagia scale

    Time frame: baseline/ change from baseline when electrical stimulation applied(the object of this study is to know the temporary change of dysphagia when stimulating with 4ch NMES.

    total score 100 from 0, 100 is worst outcome

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

A Double-blind, Parallel Cumulative Medical Device Pivotal Clinical Study to Assess the Safety and Efficacy of the 4 Channel NMES, Multi-center Prospective Study (Pilot Study)

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 13, 2018
Registry last updated
Jul 23, 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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