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

September 12, 2018 updated by: Ju Seok Ryu, Seoul National University Hospital

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

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.

Study Overview

Status

Terminated

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(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

Study Type

Interventional

Enrollment (Actual)

4

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
    • Gyeonggi-do
      • Seongnam, Gyeonggi-do, Korea, Republic of, 463-707
        • 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

No

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: classical electrical stimulation protocol
  • 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.
Device: 4 channel Electrical Stimulation Device
electrical stimulation at muscles which related with deglutition
Experimental: revised sequential activation protocol
  • 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.
Device: 4 channel Electrical Stimulation Device
electrical stimulation at muscles which related with deglutition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.)
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.)
videofluoroscopic dysphagia scale
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.
total score 100 from 0, 100 is worst outcome
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.

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)

March 1, 2018

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

April 6, 2018

First Submitted That Met QC Criteria

September 7, 2018

First Posted (Actual)

September 10, 2018

Study Record Updates

Last Update Posted (Actual)

September 14, 2018

Last Update Submitted That Met QC Criteria

September 12, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-1706/402-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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