NCT03664479

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.

Trial Health

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Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 6, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 10, 2018

Completed
Last Updated

September 14, 2018

Status Verified

February 1, 2018

Enrollment Period

3 months

First QC Date

April 6, 2018

Last Update Submit

September 12, 2018

Conditions

Dysphagia

Keywords

strokecervical spinal cord injury

Outcome Measures

Primary Outcomes (2)

  • pressure change

    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

    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)

classical electrical stimulation protocol

EXPERIMENTAL

* 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

revised sequential activation protocol

EXPERIMENTAL

* 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

Interventions

4 channel Electrical Stimulation DeviceDEVICE

electrical stimulation at muscles which related with deglutition

classical electrical stimulation protocolrevised sequential activation protocol

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, Gyeonggi-do, 463-707, South Korea

Location

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

  • Jusuk 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

April 6, 2018

First Posted

September 10, 2018

Study Start

March 1, 2018

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

September 14, 2018

Record last verified: 2018-02

Locations

KR(1)