DysphagiaNCT03664479
Assess the Safety and Efficacy of the 4 Channel NMES, Pilot Study
A study testing 4 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
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Mar 2018to 1 Jun 2018
- 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, Gyeonggi-do, 463-707
About this study
Official title: 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.
Read the 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
- Conditions
- Dysphagia
- Being tested
- 4 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: 4 channel Electrical Stimulation Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
pressure change
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.)
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 posted10 Sep 2018
- Study start1 Mar 2018
- Primary completion1 Jun 2018
- Study completion1 Jun 2018
Why it stopped: collected data showed significant difference in two groups.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 4 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
- Jusuk Ryu, M.D. PhD, Study director, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03664479
- Sponsor's protocol ID
- E-1706/402-001
- Status last verified
- Feb 2018
- First submitted
- 6 Apr 2018
- Last updated
- 14 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03664479
- Acronym / sponsor ID
- E-1706/402-001
- Conditions
- Dysphagia
- Keywords
- stroke, cervical spinal cord injury
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: collected data showed significant difference in two groups.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 10 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 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| classical electrical stimulation protocol | Experimental | Device: 4 channel Electrical Stimulation Device* 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. |
| revised sequential activation protocol | Experimental | Device: 4 channel Electrical Stimulation Device* 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. |
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 | classical electrical stimulation protocol, revised sequential activation protocol |
Primary outcome
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.)
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 was stopped early (reason given: collected data showed significant difference in two groups.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2018.
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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 4 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: stopped early, as of the sponsor's last update on 14 Sep 2018. 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 was stopped early (reason given: collected data showed significant difference in two groups.). Results are not available in the source record.
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 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.)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2018.