To Assess the Safety and Efficacy of the 4 Channel NMES Compensatory Medical Device in Swallowing, Multicenter Study

This study is a confirmation 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 validate the 4ch NMES device.

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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, Bundang, 13364, 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: applied electrical stimulation by a "Synchronized Electrical Stimulation Device(SESD)"
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

Primary outcomes

The Modified Barium Swallow Impairment Profile (MBSImP™©)

Time frame: Change from Baseline without stimulation at within 1 weeks with electrical stimulation applied

total score 0 from 55, 55 is worst outcome

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

A Prospective Study of Compensatory Medical Device Pivotal Clinical Study to Assess the Safety and Efficacy of the 4 Channel NMES, Multicenter Study

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Sep 13, 2018
Registry last updated: Aug 4, 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.

Published trials that share one or more normalized conditions with this study.

Completed