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The Safety and Efficacy of the 4 Channel NMES on Swallowing

Primary Purpose

Dysphagia

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
4 channel Electrical Stimulation Device
2 channel Electrical Stimulation Device
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysphagia focused on measuring stroke, cervical spinal cord injury

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

4 channel Electrical Stimulation(revised sequential)

2 channel Electrical Stimulation(classical)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

videofluoroscopic dysphagia scale
total score 100 from 0, 100 is worst outcome

Secondary Outcome Measures

Full Information

First Posted
September 12, 2018
Last Updated
July 22, 2020
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03670498
Brief Title
The Safety and Efficacy of the 4 Channel NMES on Swallowing
Official 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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
August 4, 2019 (Actual)
Study Completion Date
August 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia
Keywords
stroke, cervical spinal cord injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
4 channel Electrical Stimulation(revised sequential)
Arm Type
Experimental
Arm Description
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.
Arm Title
2 channel Electrical Stimulation(classical)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
4 channel Electrical Stimulation Device
Intervention Description
electrical stimulation at muscles which related with deglutition
Intervention Type
Device
Intervention Name(s)
2 channel Electrical Stimulation Device
Intervention Description
electrical stimulation at muscles which related with deglutition
Primary Outcome Measure Information:
Title
videofluoroscopic dysphagia scale
Description
total score 100 from 0, 100 is worst outcome
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ju Seok Ryu, M.D. PhD
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Kyungji-do
ZIP/Postal Code
13620
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34059092
Citation
Seo KH, Jang J, Jang EG, Park Y, Lee SY, Kim BR, Park D, Park S, Hwang H, Kim NH, Oh BM, Seo HG, Lee JC, Ryu JS. 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. J Neuroeng Rehabil. 2021 May 31;18(1):90. doi: 10.1186/s12984-021-00884-6.
Results Reference
derived

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The Safety and Efficacy of the 4 Channel NMES on Swallowing

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