search
Back to results

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

Primary Purpose

Dysphagia

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
4 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

No Intervention

Arm Label

Revised sequential activation protocol

control subject

Arm Description

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.

Apply 4 channel electrical stimulation device without any stimulation

Outcomes

Primary Outcome Measures

The Modified Barium Swallow Impairment Profile (MBSImP™©)
total score 0 from 55, 55 is worst outcome

Secondary Outcome Measures

Full Information

First Posted
September 12, 2018
Last Updated
July 31, 2020
Sponsor
Seoul National University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03670485
Brief Title
To Assess the Safety and Efficacy of the 4 Channel NMES Compensatory Medical Device in Swallowing, Multicenter Study
Official Title
A Prospective Study of Compensatory Medical Device Pivotal Clinical Study to Assess the Safety and Efficacy of the 4 Channel NMES, Multicenter Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
February 21, 2020 (Actual)
Study Completion Date
February 21, 2020 (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 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.
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

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
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Revised sequential activation protocol
Arm Type
Experimental
Arm Description
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.
Arm Title
control subject
Arm Type
No Intervention
Arm Description
Apply 4 channel electrical stimulation device without any stimulation
Intervention Type
Device
Intervention Name(s)
4 channel Electrical Stimulation Device
Intervention Description
electrical stimulation at muscles which related with deglutition
Primary Outcome Measure Information:
Title
The Modified Barium Swallow Impairment Profile (MBSImP™©)
Description
total score 0 from 55, 55 is worst outcome
Time Frame
Change from Baseline without stimulation at within 1 weeks with electrical stimulation applied

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
Jusuk 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
Bundang
ZIP/Postal Code
13364
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs