NCT03670498

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 13, 2018

Completed
18 days until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 4, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 4, 2019

Completed
Last Updated

July 23, 2020

Status Verified

July 1, 2020

Enrollment Period

10 months

First QC Date

September 12, 2018

Last Update Submit

July 22, 2020

Conditions

Dysphagia

Keywords

strokecervical spinal cord injury

Outcome Measures

Primary Outcomes (1)

  • videofluoroscopic dysphagia scale

    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.

Study Arms (2)

4 channel Electrical Stimulation(revised sequential)

EXPERIMENTAL

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.

Device: 4 channel Electrical Stimulation Device

2 channel Electrical Stimulation(classical)

ACTIVE COMPARATOR

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.

Device: 2 channel Electrical Stimulation Device

Interventions

4 channel Electrical Stimulation DeviceDEVICE

electrical stimulation at muscles which related with deglutition

4 channel Electrical Stimulation(revised sequential)
2 channel Electrical Stimulation DeviceDEVICE

electrical stimulation at muscles which related with deglutition

2 channel Electrical Stimulation(classical)

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Kyungji-do, 13620, South Korea

Location

Related Publications (2)

  • Lim J, Lee JC, Jang EG, Choi SY, Seo KH, Lee SY, Park D, Oh BM, Seo HG, Ryu JS. Kinematic mechanism of the rehabilitative effect of 4-channel NMES: post-hoc analysis of a prospective randomized controlled study. Sci Rep. 2023 Aug 18;13(1):13445. doi: 10.1038/s41598-023-40359-3.

    PMID: 37596323DERIVED

  • 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.

    PMID: 34059092DERIVED

MeSH Terms

Conditions

Deglutition DisordersStroke

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Ju Seok Ryu, M.D. PhD

    Seoul National University Bundang Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

September 12, 2018

First Posted

September 13, 2018

Study Start

October 1, 2018

Primary Completion

August 4, 2019

Study Completion

August 4, 2019

Last Updated

July 23, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)