The Safety and Efficacy of the 4 Channel NMES on Swallowing

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2019-08-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT03670485

Dysphagia

COMPLETED NA

Clinical Trial for Clinical Excellence and Safety Evaluation of 4-channel Functional Electric Stimulator

NCT05483582

Dysphagia

RECRUITING NA

Effect of Surface Electrical Stimulation on Movement of the Larynx

NCT00104000

Healthy

COMPLETED

Register Study: Implementation of Pharyngeal Electrostimulation Therapy for the Treatment of Acute Neurogenic Dysphagia

NCT05190718

Neurogenic Dysphagia Traumatic Brain Injury Stroke +4 more

RECRUITING

Effects of Phrenic Nerve Stimulation During Swallowing : Experimental Model of Aspiration

NCT00213343

Velopharyngeal Insufficiency

TERMINATED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

* 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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dysphagia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

4 channel Electrical Stimulation(revised sequential)

apply 4 channel electrical stimulation device with protocol Is a revised sequential activation protocol, it sequentially Rt. suprahyoid m (ch 1), Lt. suprahyoid m (ch 2), thyrohyoid m (ch 3), sternothyroid m (ch 4) with 4 channel electrical stimulation device.

Group Type EXPERIMENTAL

4 channel Electrical Stimulation Device

Intervention Type DEVICE

electrical stimulation at muscles which related with deglutition

2 channel Electrical Stimulation(classical)

apply 2 channel electrical stimulation device with protocol Is a revised sequential activation protocol, it simultaneously suprahyoid m (ch 1), thyrohyoid m (ch 2) with 2 channel electrical stimulation device.

Group Type ACTIVE_COMPARATOR

2 channel Electrical Stimulation Device

Intervention Type DEVICE

electrical stimulation at muscles which related with deglutition

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

4 channel Electrical Stimulation Device

electrical stimulation at muscles which related with deglutition

Intervention Type DEVICE

2 channel Electrical Stimulation Device

electrical stimulation at muscles which related with deglutition

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes