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NCT03670498

The Safety and Efficacy of the 4 Channel NMES on Swallowing

Completed NA Last updated 23 July 2020
What this trial tests

NA trial testing 4 channel Electrical Stimulation Device in Dysphagia in 26 participants. Completed in 4 August 2019.

Timeline
1 October 2018
Primary endpoint
4 August 2019
4 August 2019

Quick facts

Lead sponsorSeoul National University Hospital
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment26
Start date1 October 2018
Primary completion4 August 2019
Estimated completion4 August 2019
Sites1 location across South Korea

Drugs / interventions tested

Conditions studied

Sponsor

Seoul National University Hospital

Who can join

19 and older, any sex, with Dysphagia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Clinical effectiveness of the sequential 4-channel NMES compared with that of the conventional 2-channel NMES for the treatment of dysphagia in a prospective double-blind randomized controlled study.
    Seo KH, Jang J, Jang EG, Park Y, et al · · 2021 · cited 10× · PMID 34059092 · DOI 10.1186/s12984-021-00884-6
  2. Kinematic mechanism of the rehabilitative effect of 4-channel NMES: post-hoc analysis of a prospective randomized controlled study.
    Lim J, Lee JC, Jang EG, Choi SY, et al · · 2023 · cited 4× · PMID 37596323 · DOI 10.1038/s41598-023-40359-3
  3. Effectiveness of the sequential 4-channel NMES compared with conventional 2-channel NMES for the treatment of dysphagia in a prospective double-blind randomized controlled study
    Seo K, Jang J, Jang EG, Park Y, et al · · 2020 · DOI 10.21203/rs.3.rs-94350/v1

Verify or expand the search:

Other trials of 4 channel Electrical Stimulation Device

Trials testing the same drug.

Other recruiting trials for Dysphagia

Currently open trials in the same condition.

Other Seoul National University Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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