Not provided
Not provided
Not provided
Not provided
Not provided
collected data showed significant difference in two groups.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| classical electrical stimulation protocol | Experimental |
|
|
| revised sequential activation protocol | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4 channel Electrical Stimulation Device | Device | electrical stimulation at muscles which related with deglutition |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jusuk Ryu, M.D. PhD | Seoul National University Bundang Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 463-707 | South Korea |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 25, 2019 | |
| Reset | Sep 5, 2019 | |
| Release | Jul 22, 2020 | |
| Reset | Aug 6, 2020 | |
| Release | Oct 29, 2020 | |
| Reset | Nov 19, 2020 | |
| Release | Dec 9, 2021 | |
| Reset | Mar 1, 2022 | |
| Release | Nov 22, 2022 | |
| Reset | Sep 25, 2023 | |
| Release | Apr 19, 2024 | |
| Reset | Sep 12, 2024 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 25, 2019 | Sep 5, 2019 | |||
| Jul 22, 2020 |
| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Aug 6, 2020 |
| Oct 29, 2020 | Nov 19, 2020 |
| Dec 9, 2021 | Mar 1, 2022 |
| Nov 22, 2022 | Sep 25, 2023 |
| Apr 19, 2024 | Sep 12, 2024 |
| D010038 | Otorhinolaryngologic Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |