An interventional study of Synchronized Electrical Stimulation Device in Deglutition Disorders, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-12.
Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Treatment
The purpose of this study is to determine the synchronized electrical stimulation device effective in the treatment of dysphagia.
710 studies on the registry are indexed under Deglutition Disorders; 219 are open to participants now.
This study's enrollment of 20 is below the median of 60 across 471 interventional studies indexed under Deglutition Disorders.
Browse Deglutition Disorders studies →Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
* control group(N=10): who does not have dysphagia symptom * apply Synchronized Electrical Stimulation Device * before apply the synchronized electrical stimulation device, we will evaluate the high resolution manometry for evaluation of deglutition function * during apply the synchronized electrical stimulation device, we will evaluate the high resolution manometry for evaluation of deglutition function
Device: Synchronized Electrical Stimulation Device
* experimental group(N=10): who have dysphagia symptoms * apply Synchronized Electrical Stimulation Device * before apply the synchronized electrical stimulation device, we will evaluate the high resolution manometry for evaluation of deglutition function * during apply the synchronized electrical stimulation device, we will evaluate the high resolution manometry for evaluation of deglutition function
Device: Synchronized Electrical Stimulation Device
electrical stimulation at muscles which related with deglutition
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).
Time frame: During the electrical stimulation and electrical stimulation effects of Velopharynx, tongue base, lower pharynx and upper esophageal sphincter
| Milestone | Control Group | Experimental Group |
|---|---|---|
| Started | 10 | 10 |
| Completed | 9 | 9 |
| Not completed | 1 | 1 |
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).
| mmHg | Control Group | Experimental Group |
|---|---|---|
| Control, pressure of VP, thin | 162.04 ± 39.67 | 129.66 ± 45.58 |
| NMES, pressure of VP, thin | 200.90 ± 70.61 | 170.66 ± 77.10 |
| Control, pressure of tongue base, thick | 81.59 ± 44.51 | 136.40 ± 27.20 |
| NMES, pressure of tongue base, thick | 109.22 ± 54.36 | 151.26 ± 34.86 |
Collected over 3 days after finishing the examination.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control Group | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Experimental Group | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Age, Continuous(years) | Control Group | Experimental Group | Total |
|---|---|---|---|
| Mean | 51.6 ± 11.99 | 65.9 ± 13.06 | 58.75 ± 12.5 |
| Sex: Female, Male(Participants) | Control Group | Experimental Group | Total |
|---|---|---|---|
| Female | 4 | 2 | 6 |
| Male | 6 | 8 | 14 |
| Race and Ethnicity Not Collected(Participants) | Control Group | Experimental Group | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Control Group | Experimental Group | Total |
|---|---|---|---|
| South Korea | 10 | 10 | 20 |
| Disease(Participants) | Control Group | Experimental Group | Total |
|---|---|---|---|
| Stroke | 0 | 4 | 4 |
| Brain tumor | 0 | 1 | 1 |
| Cerebral palsy | 0 | 1 | 1 |
| Guillain-Barre syndrome | 0 | 1 | 1 |
| Spinal cord injury | 0 | 1 | 1 |
| Unknown | 0 | 2 | 2 |
| Healthy | 10 | 0 | 10 |
Plan to share: No
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Seoul National University Hospital