Deglutition DisordersNCT02718963

Treatment of Dysphagia by Using a Synchronized Electrical Stimulation Device

A study testing Synchronized Electrical Stimulation Device in people with Deglutition Disorders, run by Seoul National University Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine the synchronized electrical stimulation device effective in the treatment of dysphagia. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Deglutition Disorders
What is being tested?: Synchronized Electrical Stimulation Device
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteSouth Korea
Study dates: 15 Jul 2015to 24 Jun 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

who have dysphagia symptoms and verified deglutition disorder by video fluoro swallowing study

Who cannot join

who reject the checkup their deglutition function by high resolution manometry
who reject apply "Synchronized Electrical Stimulator"

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Department of Rehabilitation Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine
Seongnam-si, Gyeonggi-do, 463-707

Other trials in South Korea

About this study

The purpose of this study is to determine the synchronized electrical stimulation device effective in the treatment of dysphagia.

Read the detailed description

Design: Prospective study
Inclusion criteria of the patient group: who has a dysphagia symptom and confirmed by video-fluoroscopic swallowing study(N=10)
Inclusion criteria of the control group: who does not have any dysphagia symptoms, and does not have any underlying disease(N=10)
Setting: Hospital rehabilitation department
Intervention: Participants are applied electrical stimulation by a "Synchronized Electrical Stimulation Device(SESD)"

Conditions: Deglutition Disorders
Being tested: Synchronized Electrical Stimulation Device
Medical subject headings: Deglutition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Synchronized Electrical Stimulation DeviceDevice
electrical stimulation at muscles which related with deglutition

Study groups in NCT02718963
Study group	Role	What they receive
Control group	Experimental	* control group(N=10): who does not have dysphagia symptom * apply Synchronized Electrical Stimulation Device * before apply the synchronized electrical stimulation device, we will evaluate the high resolution manometry for evaluation of deglutition function * during apply the synchronized electrical stimulation device, we will evaluate the high resolution manometry for evaluation of deglutition function Receives: Device: Synchronized Electrical Stimulation Device
Experimental group	Experimental	* experimental group(N=10): who have dysphagia symptoms * apply Synchronized Electrical Stimulation Device * before apply the synchronized electrical stimulation device, we will evaluate the high resolution manometry for evaluation of deglutition function * during apply the synchronized electrical stimulation device, we will evaluate the high resolution manometry for evaluation of deglutition function Receives: Device: Synchronized Electrical Stimulation Device

What is being measured

The primary outcome is the main question the study is designed to answer.

Pressure and Timing Change of Velopharynx, Tongue Base, Low Pharynx and Upper Esophageal Sphincter.
Maximal pressure, integral, rise time, and duration in the regions of VP and TB (the time interval over the VP and TB integral).
The maximal pressure of low pharynx (LP) (C in supplementary 1), maximal pre-upper esophageal sphincter (UES) pressure (F in supplementary 1), maximal cricopharyngeus (CP) pressure (D in supplementary 1), minimal upper esophageal sphincter (UES) pressure, upper esophageal sphincter (UES) activity time (the interval between pre-upper esophageal sphincter (UES) peak and post-upper esophageal sphincter (UES) peak; G in supplementary 1), and nadir upper esophageal sphincter (UES) pressure duration in the region of upper esophageal sphincter (UES).
Measured: During the electrical stimulation and electrical stimulation effects of Velopharynx, tongue base, lower pharynx and upper esophageal sphincter

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jul 201524 Jun 2016

First posted24 Mar 2016 (estimated)
Study start15 Jul 2015
Primary completion24 Jun 2016
Study completion24 Jun 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Deglutition DisordersStudies of the same condition, open and under way.
More trials run by Seoul National University HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02718963
Sponsor's protocol ID: B-1507/306-002
Status last verified: Oct 2020
First submitted: 20 Mar 2016
Last updated: 12 Nov 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

Park D, Suh JH, Kim H, Ryu JS. The Effect of Four-Channel Neuromuscular Electrical Stimulation on Swallowing Kinematics and Pressures: A Pilot Study. Am J Phys Med Rehabil. 2019 Dec;98(12):1051-1059. doi: 10.1097/PHM.0000000000001241.
PubMed 31180928
Lim J, Hyun SE, Kim H, Ryu JS. Residual effect of sequential 4-channel neuromuscular electrical stimulation evaluated by high-resolution manometry. Biomed Eng Online. 2024 Jul 25;23(1):70. doi: 10.1186/s12938-024-01269-1.
PubMed 39049019

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Deglutition Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Treatment of Dysphagia by Using a Synchronized Electrical Stimulation Device
ClinicalTrials.gov ID: NCT02718963
Acronym / sponsor ID: B-1507/306-002
Conditions: Deglutition Disorders
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Seoul National University HospitalUniversity, hospital or other
Study start: 15 Jul 2015 (actual)
Primary completion: 24 Jun 2016 (actual)
Study completion: 24 Jun 2016 (actual)
First posted: 24 Mar 2016 (estimated)
Results: Posted 12 Nov 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to determine the synchronized electrical stimulation device effective in the treatment of dysphagia.

Detailed description

Design: Prospective study
Inclusion criteria of the patient group: who has a dysphagia symptom and confirmed by video-fluoroscopic swallowing study(N=10)
Inclusion criteria of the control group: who does not have any dysphagia symptoms, and does not have any underlying disease(N=10)
Setting: Hospital rehabilitation department
Intervention: Participants are applied electrical stimulation by a "Synchronized Electrical Stimulation Device(SESD)"

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Control group	Experimental	Device: Synchronized Electrical Stimulation Device* control group(N=10): who does not have dysphagia symptom * apply Synchronized Electrical Stimulation Device * before apply the synchronized electrical stimulation device, we will evaluate the high resolution manometry for evaluation of deglutition function * during apply the synchronized electrical stimulation device, we will evaluate the high resolution manometry for evaluation of deglutition function
Experimental group	Experimental	Device: Synchronized Electrical Stimulation Device* experimental group(N=10): who have dysphagia symptoms * apply Synchronized Electrical Stimulation Device * before apply the synchronized electrical stimulation device, we will evaluate the high resolution manometry for evaluation of deglutition function * during apply the synchronized electrical stimulation device, we will evaluate the high resolution manometry for evaluation of deglutition function

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

who have dysphagia symptoms and verified deglutition disorder by video fluoro swallowing study

Key exclusion criteria (2 listed)

who reject the checkup their deglutition function by high resolution manometry
who reject apply "Synchronized Electrical Stimulator"

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Synchronized Electrical Stimulation Deviceelectrical stimulation at muscles which related with deglutition	Device	Control group, Experimental group

Primary outcome

Pressure and Timing Change of Velopharynx, Tongue Base, Low Pharynx and Upper Esophageal Sphincter.
Time frame: During the electrical stimulation and electrical stimulation effects of Velopharynx, tongue base, lower pharynx and upper esophageal sphincter
Maximal pressure, integral, rise time, and duration in the regions of VP and TB (the time interval over the VP and TB integral). The maximal pressure of low pharynx (LP) (C in supplementary 1), maximal pre-upper esophageal sphincter (UES) pressure (F in supplementary 1), maximal cricopharyngeus (CP) pressure (D in supplementary 1), minimal upper esophageal sphincter (UES) pressure, upper esophageal sphincter (UES) activity time (the interval between pre-upper esophageal sphincter (UES) peak and post-upper esophageal sphincter (UES) peak; G in supplementary 1), and nadir upper esophageal sphincter (UES) pressure duration in the region of upper esophageal sphincter (UES).

Results and safety

Results posted to the registry on 12 Nov 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control Group	10	9
Experimental Group	10	9

Primary outcome: Pressure and Timing Change of Velopharynx, Tongue Base, Low Pharynx and Upper Esophageal Sphincter.

Time frame: During the electrical stimulation and electrical stimulation effects of Velopharynx, tongue base, lower pharynx and upper esophageal sphincter. Mean (Standard Deviation). Unit: mmHg

Measure	Control Group n = 10	Experimental Group n = 10
Control, pressure of VP, thin	162.04 (39.67)	129.66 (45.58)
NMES, pressure of VP, thin	200.90 (70.61)	170.66 (77.10)
Control, pressure of tongue base, thick	81.59 (44.51)	136.40 (27.20)
NMES, pressure of tongue base, thick	109.22 (54.36)	151.26 (34.86)

Control Group vs Experimental Group: Mean Difference (Final Values): 0.05, p < 0.05, Wilcoxon (Mann-Whitney)

Adverse events

Time frame: 3 days after finishing the examination.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control Group	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Experimental Group	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Limitations and caveats (from the sponsor): First, a small number of subjects were included. Second, the sequential 4-channel NMES was not directly compared with the 2-channel NMES. Third, some prospectively enrolled healthy participants in our study had asymptomatic penetration in VFSS.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 31180928Park D, Suh JH, Kim H, Ryu JS. The Effect of Four-Channel Neuromuscular Electrical Stimulation on Swallowing Kinematics and Pressures: A Pilot Study. Am J Phys Med Rehabil. 2019 Dec;98(12):1051-1059. doi: 10.1097/PHM.0000000000001241.
Derived from this study: PubMed 39049019Lim J, Hyun SE, Kim H, Ryu JS. Residual effect of sequential 4-channel neuromuscular electrical stimulation evaluated by high-resolution manometry. Biomed Eng Online. 2024 Jul 25;23(1):70. doi: 10.1186/s12938-024-01269-1.
Individual participant dataSharing planned: No

Related trials for Deglutition Disorders

RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
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Recruiting
The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
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Active, not recruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jusuk Ryu, M.D. PhD study director

Seoul National University Bundang Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Synchronized Electrical Stimulation Device in people with Deglutition Disorders, run by Seoul National University Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pressure and Timing Change of Velopharynx, Tongue Base, Low Pharynx and Upper Esophageal Sphincter. (time frame: During the electrical stimulation and electrical stimulation effects of Velopharynx, tongue base, lower pharynx and upper esophageal sphincter). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02718963, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2020.