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Assess the Safety and Efficacy of the 4 Channel NMES, Pilot Study

Primary Purpose

Dysphagia

Status
Terminated
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

Experimental

Arm Label

classical electrical stimulation protocol

revised sequential activation protocol

Arm Description

apply 4 channel electrical stimulation device with protocol 1. It will simultaneously stimulate suprahyoid, thyrohyoid and sternothyroid m with 4 channel electrical stimulation device. during apply the device, we evaluate the manometry and videofluoroscopic swallowing study for evaluation of deglutition function.

apply 4 channel electrical stimulation device with protocol 2 Is a revised sequential activation protocol, it sequentially stimulate bilateral suprahyoid m (channel 1), pharyngeal constrictors (ch 2), thyrohyoid m (ch 3), sternothyroid m (ch 4) with 4 channel electrical stimulation device. during apply the synchronized electrical stimulation device, we will evaluate the parameters same as group 1.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 6, 2018
Last Updated
September 12, 2018
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03664479
Brief Title
Assess the Safety and Efficacy of the 4 Channel NMES, Pilot Study
Official Title
A Double-blind, Parallel Compensatory Medical Device Pivotal Clinical Study to Assess the Safety and Efficacy of the 4 Channel Neuromuscular Electrical Stimulation (NMES), Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Terminated
Why Stopped
collected data showed significant difference in two groups.
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
June 1, 2018 (Actual)
Study Completion Date
June 1, 2018 (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 effect by the electric stimulation method 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(N=9) Intervention: Participants are divided into two group and applied electrical stimulation by a "Synchronized Electrical Stimulation Device(SESD)" in different protocol Main outcome measures: high-resolution manometry(HRM) parameters, videofluoroscopic parameters, EQ-5D (EuroQoL-5D) questionnaire

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
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
classical electrical stimulation protocol
Arm Type
Experimental
Arm Description
apply 4 channel electrical stimulation device with protocol 1. It will simultaneously stimulate suprahyoid, thyrohyoid and sternothyroid m with 4 channel electrical stimulation device. during apply the device, we evaluate the manometry and videofluoroscopic swallowing study for evaluation of deglutition function.
Arm Title
revised sequential activation protocol
Arm Type
Experimental
Arm Description
apply 4 channel electrical stimulation device with protocol 2 Is a revised sequential activation protocol, it sequentially stimulate bilateral suprahyoid m (channel 1), pharyngeal constrictors (ch 2), thyrohyoid m (ch 3), sternothyroid m (ch 4) with 4 channel electrical stimulation device. during apply the synchronized electrical stimulation device, we will evaluate the parameters same as group 1.
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
pressure change
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.)
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
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
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of

12. IPD Sharing Statement

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Assess the Safety and Efficacy of the 4 Channel NMES, Pilot Study

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