DysphagiaNCT05483582
Clinical Trial for Clinical Excellence and Safety Evaluation of 4-channel Functional Electric Stimulator
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 to 90 yearsHealthy 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
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Sep 2023to 31 Dec 2025
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with oropharyngeal dysphagia confirmed by video fluoroscopy
- Patients with oropharyngeal dysphagia due to central nervous system disease who clinically require application of an electrical stimulation treatment device for dysphagia
- Patients aged between 19 and under 90 years of age regardless of gender
- Those who voluntarily consent to the clinical trial and can visit for the next observation
- Patients with dysphagia within 6 months (including patients with dysphagia due to stroke, traumatic brain injury, cervical spine injury, etc.)
Who cannot join
- In case of refusal of inspection
- Who do not agree
- When instructions cannot be performed due to mental illness, etc.
- Those who have dysphagia due to respiratory failure, cervical spine surgery, head and neck surgery, and chemotherapy and radiation treatment of the neck
- Pregnant and lactating women
- Pre-interview is conducted only with women of childbearing age to determine whether they are pregnant or lactating. If pregnancy is confirmed during the pre-interview, it is excluded from the test.
Show all 11Show fewer
- Patients who cannot apply electrical stimulation therapy due to allergies or hypersensitivity reactions
- Others who have comorbidities (e.g., malignant tumors, severe renal/liver/lung diseases, blood clotting abnormalities, etc.) that are inappropriate for participation in clinical trials as judged by the researcher
- Persons with pacemakers and other internal electrical stimulators
- Those who are participating in other clinical trials at the time of screening
- Those who are judged by other researchers to be inappropriate for this clinical trial
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Rehabilitation Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine
Seongnam-si, Gyeonggi-do, 463-707
Juseok Ryu, M.D, PhD, +82-31-787-7739, jseok337@snu.ac.kr
Seungwoo Lee, CRA, +82-5181-8066, r4105@snubh.org
About this study
Official title: Clinical Trial to Evaluate the Efficacy and Safety of a 4-channel Swallowing Function Electrical Stimulation Device Compared to a 2-channel Swallowing Function Electrical Stimulation Device for the Rehabilitation Mechanism
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
- Intervention: Participants are divided into two group and applied electrical stimulation by a "Synchronized Electrical Stimulation Device(SESD)" in different protocol
- Main outcome measures: Videofluoroscopic Dysphagia Scale (VDS), Penetration aspiration scale (PAS), Measured by kinematic metaphysical analysis. The dietary status of the subjects was evaluated by the Functional Oral Intake Scale (FOIS), and the M.D Anderson dysphagia inventory was used to measure the diet-related quality of life. The Likert scale is used to evaluate the satisfaction with the application of the electric stimulation therapy device of the study subjects.
- Secondary outcome measures: Verifying the safety of functional electric stimulation therapy device for dysphagia, measuring the effect on Tongue Strength through IOPI, the effect on changes in body composition through Bioelectrical Impedance Analysis (BIA; InBody S10, InBody, Inc.), and whether there is a significant change in actual patient intake and nutritional status through oral intake survey and MNA-SF measure. An exploratory comparison of intervention effects over time between 2-week and 4-week interventions.
- Conditions
- Dysphagia
- Being tested
- 4-channel Electrical Stimulation Device, 2-channel 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.
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 |
|---|---|---|
| classical electrical stimulation protocol (control group) | Active comparator | * Apply 2-channel electrical stimulation device with protocol 1.
* It will simultaneously stimulate bilateral suprahyoid, bilateral thyrohyoid muscle with 2-channel electrical stimulation device.
* Basic intervention involves 600-900 minutes of electrical stimulation for 2 weeks. (based on 60 minutes per 1 time, applied 10 times(+5 times, within 1 week))
* With the consent of the patient, an additional evaluation is performed after additional 2 weeks of intervention, which is use as an exploratory indicator.
* After application of the device, we evaluate videofluoroscopic swallowing study(VFSS) for evaluation of swallowing function.
* In addition, we evaluate clinical questionnaires(FOIS, MDADI, Likert scale), nutritional status assessments(MNA-SF), and oral intake assessments.
* Also, we measure tongue strength through IOPI and body composition changes through Inbody. Receives: Device: 2-channel Electrical Stimulation Device |
| revised sequential activation protocol (experimental group) | Experimental | * Apply 4-channel electrical stimulation device with protocol 2.
* It sequentially stimulates bilateral suprahyoid muscle(ch 1, ch 2), bilateral thyrohyoid muscle(ch 3), bilateral sternothyroid muscle(ch 4) with 4-channel electrical stimulation device.
* Basic intervention involves 600-900 minutes of electrical stimulation for 2 weeks. (based on 60 minutes per 1 time, applied 10 times(+5 times, within 1 week))
* With the consent of the patient, an additional evaluation is performed after additional 2 weeks of intervention, which is use as an exploratory indicator.
* After application of the device, we evaluate videofluoroscopic swallowing study(VFSS) for evaluation of swallowing function.
* In addition, we evaluate clinical questionnaires(FOIS, MDADI, Likert scale), nutritional status assessments(MNA-SF), and oral intake assessments.
* Also, we measure tongue strength through IOPI and body composition changes through Inbody. Receives: Device: 4-channel Electrical Stimulation Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of VDS total change
Comparison of VDS total change between the two groups using the results of the video fluoroscopic swallowing test between the experimental group and the control group
Measured: 300 to 600 minutes
Secondary outcomes (4)
Using the results of the video fluoroscopic swallowing test
Comparison of changes in VDS (oral score, pharyngeal score), PAS (Penetration Aspiration Scale) and kinematic analysis using the results of video fluoroscopic swallowing test.
Measured: 300 to 600 minutes
Results of pre- and post-intervention surveys
The dietary status of the subjects was evaluated by the Functional Oral Intake Scale (FOIS), and the M.D anderson dysphagia inventory was used to measure the diet-related quality of life.
Measured: 30 to 60 minutes
Satisfaction evaluation of treatment device
The Likert scale is used to evaluate the satisfaction with the application of the electric stimulation therapy device of the study subjects.
Measured: 10 to 30 minutes
Exploratory observation of the effect of electrical stimulation therapy
Exploratory observation of the effect of electrical stimulation therapy on tongue strength through IOPI, comparison of fluctuation values of body composition through Bioelectrical Impendance Analysis (BIA; InBody), measurement of changes in oral intake and malnutrition index before and after intervention and MNA-SF questionnaire do.
Measured: 30 to 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start1 Sep 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
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
- 68 participants (estimated)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05483582
- Sponsor's protocol ID
- E-2103-672-001
- Status last verified
- Apr 2024
- First submitted
- 1 Nov 2021
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Evaluate the Efficacy and Safety of a 4-channel Swallowing Function Electrical Stimulation Device Compared to a 2-channel Swallowing Function Electrical Stimulation Device for the Rehabilitation Mechanism
- ClinicalTrials.gov ID
- NCT05483582
- Acronym / sponsor ID
- E-2103-672-001
- Conditions
- Dysphagia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 2 Aug 2022 (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
- Intervention: Participants are divided into two group and applied electrical stimulation by a "Synchronized Electrical Stimulation Device(SESD)" in different protocol
- Main outcome measures: Videofluoroscopic Dysphagia Scale (VDS), Penetration aspiration scale (PAS), Measured by kinematic metaphysical analysis. The dietary status of the subjects was evaluated by the Functional Oral Intake Scale (FOIS), and the M.D Anderson dysphagia inventory was used to measure the diet-related quality of life. The Likert scale is used to evaluate the satisfaction with the application of the electric stimulation therapy device of the study subjects.
- Secondary outcome measures: Verifying the safety of functional electric stimulation therapy device for dysphagia, measuring the effect on Tongue Strength through IOPI, the effect on changes in body composition through Bioelectrical Impedance Analysis (BIA; InBody S10, InBody, Inc.), and whether there is a significant change in actual patient intake and nutritional status through oral intake survey and MNA-SF measure. An exploratory comparison of intervention effects over time between 2-week and 4-week interventions.
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 (control group) | Active comparator | Device: 2-channel Electrical Stimulation Device* Apply 2-channel electrical stimulation device with protocol 1. * It will simultaneously stimulate bilateral suprahyoid, bilateral thyrohyoid muscle with 2-channel electrical stimulation device. * Basic intervention involves 600-900 minutes of electrical stimulation for 2 weeks. (based on 60 minutes per 1 time, applied 10 times(+5 times, within 1 week)) * With the consent of the patient, an additional evaluation is performed after additional 2 weeks of intervention, which is use as an exploratory indicator. * After application of the device, we evaluate videofluoroscopic swallowing study(VFSS) for evaluation of swallowing function. * In addition, we evaluate clinical questionnaires(FOIS, MDADI, Likert scale), nutritional status assessments(MNA-SF), and oral intake assessments. * Also, we measure tongue strength through IOPI and body composition changes through Inbody. |
| revised sequential activation protocol (experimental group) | Experimental | Device: 4-channel Electrical Stimulation Device* Apply 4-channel electrical stimulation device with protocol 2. * It sequentially stimulates bilateral suprahyoid muscle(ch 1, ch 2), bilateral thyrohyoid muscle(ch 3), bilateral sternothyroid muscle(ch 4) with 4-channel electrical stimulation device. * Basic intervention involves 600-900 minutes of electrical stimulation for 2 weeks. (based on 60 minutes per 1 time, applied 10 times(+5 times, within 1 week)) * With the consent of the patient, an additional evaluation is performed after additional 2 weeks of intervention, which is use as an exploratory indicator. * After application of the device, we evaluate videofluoroscopic swallowing study(VFSS) for evaluation of swallowing function. * In addition, we evaluate clinical questionnaires(FOIS, MDADI, Likert scale), nutritional status assessments(MNA-SF), and oral intake assessments. * Also, we measure tongue strength through IOPI and body composition changes through Inbody. |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with oropharyngeal dysphagia confirmed by video fluoroscopy
- Patients with oropharyngeal dysphagia due to central nervous system disease who clinically require application of an electrical stimulation treatment device for dysphagia
- Patients aged between 19 and under 90 years of age regardless of gender
- Those who voluntarily consent to the clinical trial and can visit for the next observation
- Patients with dysphagia within 6 months (including patients with dysphagia due to stroke, traumatic brain injury, cervical spine injury, etc.)
Key exclusion criteria (11 listed)
- In case of refusal of inspection
- Who do not agree
- When instructions cannot be performed due to mental illness, etc.
- Those who have dysphagia due to respiratory failure, cervical spine surgery, head and neck surgery, and chemotherapy and radiation treatment of the neck
- Pregnant 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 | revised sequential activation protocol (experimental group) |
| 2-channel Electrical Stimulation Deviceelectrical stimulation at muscles which related with deglutition | Device | classical electrical stimulation protocol (control group) |
Primary outcome
Comparison of VDS total change
Time frame: 300 to 600 minutes
Comparison of VDS total change between the two groups using the results of the video fluoroscopic swallowing test between the experimental group and the control group
4 secondary outcomes
Using the results of the video fluoroscopic swallowing test
Time frame: 300 to 600 minutes
Results of pre- and post-intervention surveys
Time frame: 30 to 60 minutes
Satisfaction evaluation of treatment device
Time frame: 10 to 30 minutes
Exploratory observation of the effect of electrical stimulation therapy
Time frame: 30 to 60 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
Related trials for Dysphagia
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
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Recruiting
The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
Dysphagia, Eosinophilic Esophagitis
Recruiting
taVNS in Infants Severe Dysphagia
Dysphagia, Swallowing Disorders
Not yet recruitingPhase 2
Early Feeding TL Trial
Total Laryngectomy
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
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.
Department of Rehabilitation Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine
Seongnam-si, South Korea
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 5 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 22 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of VDS total change (time frame: 300 to 600 minutes). 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 22 Apr 2024.