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

July 31, 2020 updated by: Ju Seok Ryu, Seoul National University Hospital

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  • 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

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Bundang
      • Seongnam-si, Bundang, Korea, Republic of, 13364
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Revised sequential activation protocol

Apply 4 channel electrical stimulation device with a revised sequential activation protocol.

It sequentially activates Rt. suprahyoid m (ch 1), Lt. suprahyoid m (ch 2), thyrohyoid m (ch 3), sternothyroid m (ch 4) with 4 channel electrical stimulation device.
Device: 4 channel Electrical Stimulation Device
electrical stimulation at muscles which related with deglutition
No Intervention: control subject
Apply 4 channel electrical stimulation device without any stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from Baseline without stimulation at within 1 weeks with electrical stimulation applied

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Study Director: Jusuk Ryu, M.D. PhD, Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2019

Primary Completion (Actual)

February 21, 2020

Study Completion (Actual)

February 21, 2020

Study Registration Dates

First Submitted

September 12, 2018

First Submitted That Met QC Criteria

September 12, 2018

First Posted (Actual)

September 13, 2018

Study Record Updates

Last Update Posted (Actual)

August 4, 2020

Last Update Submitted That Met QC Criteria

July 31, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-1806-475-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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