DysphagiaNCT03670498
The Safety and Efficacy of the 4 Channel NMES on Swallowing
A study testing 4 channel Electrical Stimulation Device and 2 channel Electrical Stimulation Device in people with Dysphagia, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dysphagia
- What is being tested?
- 4 channel Electrical Stimulation Device and 2 channel Electrical Stimulation Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Oct 2018to 4 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Kyungji-do, 13620
About this study
Official title: A Double-blind, Parallel Cumulative Medical Device Pivotal Clinical Study to Assess the Safety and Efficacy of the 4 Channel NMES, Multi-center Prospective Study (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 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.
Read the detailed description
- Design: Prospective study
- Inclusion criteria of patient group: who has a dysphagia symptom and confirmed by video-fluoroscopic swallowing study
- Intervention: Participants are divided into two group and applied electrical stimulation by a "Synchronized Electrical Stimulation Device(SESD)" in 4channel or 2channel Neuromuscular Electrical Stimulation.
- Main outcome measures: videofluoroscopic parameters, EQ-5D (EuroQoL-5D) questionnaire, II. M. D Anderson dysphagia inventory
- Conditions
- Dysphagia
- Being tested
- 4 channel Electrical Stimulation Device, 2 channel Electrical Stimulation Device
- Keywords
- stroke, cervical spinal cord injury
- Medical subject headings
- Deglutition Disorders, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4 channel Electrical Stimulation DeviceDevice
electrical stimulation at muscles which related with deglutition
2 channel Electrical Stimulation DeviceDevice
electrical stimulation at muscles which related with deglutition
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: 2 channel Electrical Stimulation Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
videofluoroscopic dysphagia scale
total score 100 from 0, 100 is worst outcome
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start1 Oct 2018
- Primary completion4 Aug 2019
- Study completion4 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DysphagiaStudies 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ju Seok Ryu, Seoul National University Hospital
- Investigators
- Ju Seok Ryu, M.D. PhD, Study director, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03670498
- Sponsor's protocol ID
- E-1806/475-002
- Status last verified
- Jul 2020
- First submitted
- 12 Sep 2018
- Last updated
- 23 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37596323Seo 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.
PubMed 34059092
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Parallel Cumulative Medical Device Pivotal Clinical Study to Assess the Safety and Efficacy of the 4 Channel NMES, Multi-center Prospective Study (Pilot Study)
- ClinicalTrials.gov ID
- NCT03670498
- Acronym / sponsor ID
- E-1806/475-002
- Conditions
- Dysphagia
- Keywords
- stroke, cervical spinal cord injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 4 Aug 2019 (actual)
- Study completion
- 4 Aug 2019 (actual)
- First posted
- 13 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Design: Prospective study
- Inclusion criteria of patient group: who has a dysphagia symptom and confirmed by video-fluoroscopic swallowing study
- Intervention: Participants are divided into two group and applied electrical stimulation by a "Synchronized Electrical Stimulation Device(SESD)" in 4channel or 2channel Neuromuscular Electrical Stimulation.
- Main outcome measures: videofluoroscopic parameters, EQ-5D (EuroQoL-5D) questionnaire, II. M. D Anderson dysphagia inventory
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4 channel Electrical Stimulation(revised sequential) | Experimental | Device: 4 channel Electrical Stimulation Deviceapply 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. |
| 2 channel Electrical Stimulation(classical) | Active comparator | Device: 2 channel Electrical Stimulation Deviceapply 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| 4 channel Electrical Stimulation Deviceelectrical stimulation at muscles which related with deglutition | Device | 4 channel Electrical Stimulation(revised sequential) |
| 2 channel Electrical Stimulation Deviceelectrical stimulation at muscles which related with deglutition | Device | 2 channel Electrical Stimulation(classical) |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
- Derived from this study: PubMed 37596323Lim 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.
- Derived from this study: PubMed 34059092Seo 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.
- Individual participant dataSharing planned: No
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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.
Ju Seok 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 4 channel Electrical Stimulation Device and 2 channel Electrical Stimulation Device in people with Dysphagia, 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 4 inclusion and 5 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 23 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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.). 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 NCT03670498, 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 23 Jul 2020.