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The purpose of this study is to determine the synchronized electrical stimulation device effective in the treatment of dysphagia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Experimental |
|
|
| Experimental group | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Synchronized Electrical Stimulation Device | Device | electrical stimulation at muscles which related with deglutition |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pressure and Timing Change of Velopharynx, Tongue Base, Low Pharynx and Upper Esophageal Sphincter. | Maximal pressure, integral, rise time, and duration in the regions of VP and TB (the time interval over the VP and TB integral). The maximal pressure of low pharynx (LP) (C in supplementary 1), maximal pre-upper esophageal sphincter (UES) pressure (F in supplementary 1), maximal cricopharyngeus (CP) pressure (D in supplementary 1), minimal upper esophageal sphincter (UES) pressure, upper esophageal sphincter (UES) activity time (the interval between pre-upper esophageal sphincter (UES) peak and post-upper esophageal sphincter (UES) peak; G in supplementary 1), and nadir upper esophageal sphincter (UES) pressure duration in the region of upper esophageal sphincter (UES). | During the electrical stimulation and electrical stimulation effects of Velopharynx, tongue base, lower pharynx and upper esophageal sphincter |
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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 |
|---|---|---|---|---|---|---|
| Department of Rehabilitation Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine | Seongnam-si | Gyeonggi-do | 463-707 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31180928 | Result | Park D, Suh JH, Kim H, Ryu JS. The Effect of Four-Channel Neuromuscular Electrical Stimulation on Swallowing Kinematics and Pressures: A Pilot Study. Am J Phys Med Rehabil. 2019 Dec;98(12):1051-1059. doi: 10.1097/PHM.0000000000001241. | |
| 39049019 | Derived | Lim J, Hyun SE, Kim H, Ryu JS. Residual effect of sequential 4-channel neuromuscular electrical stimulation evaluated by high-resolution manometry. Biomed Eng Online. 2024 Jul 25;23(1):70. doi: 10.1186/s12938-024-01269-1. |
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There was no significant event in the study after participant enrollment
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group |
Synchronized Electrical Stimulation Device: electrical stimulation at muscles which related with deglutition |
| FG001 | Experimental Group |
Synchronized Electrical Stimulation Device: electrical stimulation at muscles which related with deglutition |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group |
Synchronized Electrical Stimulation Device: electrical stimulation at muscles which related with deglutition |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pressure and Timing Change of Velopharynx, Tongue Base, Low Pharynx and Upper Esophageal Sphincter. | Maximal pressure, integral, rise time, and duration in the regions of VP and TB (the time interval over the VP and TB integral). The maximal pressure of low pharynx (LP) (C in supplementary 1), maximal pre-upper esophageal sphincter (UES) pressure (F in supplementary 1), maximal cricopharyngeus (CP) pressure (D in supplementary 1), minimal upper esophageal sphincter (UES) pressure, upper esophageal sphincter (UES) activity time (the interval between pre-upper esophageal sphincter (UES) peak and post-upper esophageal sphincter (UES) peak; G in supplementary 1), and nadir upper esophageal sphincter (UES) pressure duration in the region of upper esophageal sphincter (UES). | Posted | Mean | Standard Deviation | mmHg | During the electrical stimulation and electrical stimulation effects of Velopharynx, tongue base, lower pharynx and upper esophageal sphincter |
|
3 days after finishing the examination.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group |
Synchronized Electrical Stimulation Device: electrical stimulation at muscles which related with deglutition |
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First, a small number of subjects were included. Second, the sequential 4-channel NMES was not directly compared with the 2-channel NMES. Third, some prospectively enrolled healthy participants in our study had asymptomatic penetration in VFSS.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ju Seok Ryu | Seoul National University Bundang Hospital, Seoul National University College of Medicine | 82-31-787-7739 | jseok337@snu.ac.kr |
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| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
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| BG001 | Experimental Group |
Synchronized Electrical Stimulation Device: electrical stimulation at muscles which related with deglutition |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Disease | Count of Participants | Participants |
|
control group(N=10): who does not have dysphagia symptom
apply Synchronized Electrical Stimulation Device
Synchronized Electrical Stimulation Device: electrical stimulation at muscles which related with deglutition
| OG001 | Experimental Group |
Synchronized Electrical Stimulation Device: electrical stimulation at muscles which related with deglutition |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Experimental Group |
Synchronized Electrical Stimulation Device: electrical stimulation at muscles which related with deglutition | 0 | 10 | 0 | 10 | 0 | 10 |
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| D010038 | Otorhinolaryngologic Diseases |
| Cerebral palsy |
|
| Guillain-Barre syndrome |
|
| Spinal cord injury |
|
| Unknown |
|
| Healthy |
|