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This study is a confirmation 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 validate the 4ch NMES device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Revised sequential activation protocol | Experimental | Apply 4 channel electrical stimulation device with a revised sequential activation protocol. It sequentially activates Rt. suprahyoid m (ch 1), Lt. suprahyoid m (ch 2), thyrohyoid m (ch 3), sternothyroid m (ch 4) with 4 channel electrical stimulation device. |
|
| control subject | No Intervention | Apply 4 channel electrical stimulation device without any stimulation |
| 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 |
|---|---|---|
| The Modified Barium Swallow Impairment Profile (MBSImP™©) | total score 0 from 55, 55 is worst outcome | Change from Baseline without stimulation at within 1 weeks with electrical stimulation applied |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 | Bundang | 13364 | South Korea |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 9, 2021 | |
| Reset | Feb 23, 2022 | |
| Release | Nov 29, 2022 | |
| Reset | Sep 21, 2023 | |
| Release | Apr 19, 2024 | |
| Reset | Sep 12, 2024 | |
| Release | Nov 27, 2024 | |
| Reset | Dec 4, 2024 | |
| Release | Feb 23, 2026 | |
| Unrelease | Feb 24, 2026 | |
| Release | Feb 24, 2026 | |
| Reset | Mar 17, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 9, 2021 | Feb 23, 2022 | |||
| Nov 29, 2022 |
| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
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| Sep 21, 2023 |
| Apr 19, 2024 | Sep 12, 2024 |
| Nov 27, 2024 | Dec 4, 2024 |
| Feb 23, 2026 | Feb 24, 2026 |
| Feb 24, 2026 | Mar 17, 2026 |
| D010038 | Otorhinolaryngologic Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |