Deglutition Disorders
Conditions
Brief summary
The purpose of this study is to determine the synchronized electrical stimulation device effective in the treatment of dysphagia.
Detailed description
* Design: Prospective study * Inclusion criteria of the patient group: who has a dysphagia symptom and confirmed by video-fluoroscopic swallowing study(N=10) * Inclusion criteria of the control group: who does not have any dysphagia symptoms, and does not have any underlying disease(N=10) * Setting: Hospital rehabilitation department * Intervention: Participants are applied electrical stimulation by a Synchronized Electrical Stimulation Device(SESD)
Interventions
DEVICESynchronized Electrical Stimulation Device
electrical stimulation at muscles which related with deglutition
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* who have dysphagia symptoms and verified deglutition disorder by video fluoro swallowing study
Exclusion criteria
* who reject the checkup their deglutition function by high resolution manometry * who reject apply Synchronized Electrical Stimulator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pressure and Timing Change of Velopharynx, Tongue Base, Low Pharynx and Upper Esophageal Sphincter. | During the electrical stimulation and electrical stimulation effects of Velopharynx, tongue base, lower 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). |
Countries
South Korea
Participant flow
Pre-assignment details
There was no significant event in the study after participant enrollment
Participants by arm
| Arm | Count |
|---|---|
| Control Group * 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
Synchronized Electrical Stimulation Device: electrical stimulation at muscles which related with deglutition | 10 |
| Experimental Group * 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
Synchronized Electrical Stimulation Device: electrical stimulation at muscles which related with deglutition | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Control Group | Experimental Group | Total |
|---|---|---|---|
| Age, Continuous | 51.6 years STANDARD_DEVIATION 11.99 | 65.9 years STANDARD_DEVIATION 13.06 | 58.75 years STANDARD_DEVIATION 12.5 |
| Disease Brain tumor | 0 Participants | 1 Participants | 1 Participants |
| Disease Cerebral palsy | 0 Participants | 1 Participants | 1 Participants |
| Disease Guillain-Barre syndrome | 0 Participants | 1 Participants | 1 Participants |
| Disease Healthy | 10 Participants | 0 Participants | 10 Participants |
| Disease Spinal cord injury | 0 Participants | 1 Participants | 1 Participants |
| Disease Stroke | 0 Participants | 4 Participants | 4 Participants |
| Disease Unknown | 0 Participants | 2 Participants | 2 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment South Korea | 10 participants | 10 participants | 20 participants |
| Sex: Female, Male Female | 4 Participants | 2 Participants | 6 Participants |
| Sex: Female, Male Male | 6 Participants | 8 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
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).
Time frame: During the electrical stimulation and electrical stimulation effects of Velopharynx, tongue base, lower pharynx and upper esophageal sphincter
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Pressure and Timing Change of Velopharynx, Tongue Base, Low Pharynx and Upper Esophageal Sphincter. | Control, pressure of VP, thin | 162.04 mmHg | Standard Deviation 39.67 |
| Control Group | Pressure and Timing Change of Velopharynx, Tongue Base, Low Pharynx and Upper Esophageal Sphincter. | NMES, pressure of VP, thin | 200.90 mmHg | Standard Deviation 70.61 |
| Control Group | Pressure and Timing Change of Velopharynx, Tongue Base, Low Pharynx and Upper Esophageal Sphincter. | Control, pressure of tongue base, thick | 81.59 mmHg | Standard Deviation 44.51 |
| Control Group | Pressure and Timing Change of Velopharynx, Tongue Base, Low Pharynx and Upper Esophageal Sphincter. | NMES, pressure of tongue base, thick | 109.22 mmHg | Standard Deviation 54.36 |
| Experimental Group | Pressure and Timing Change of Velopharynx, Tongue Base, Low Pharynx and Upper Esophageal Sphincter. | NMES, pressure of tongue base, thick | 151.26 mmHg | Standard Deviation 34.86 |
| Experimental Group | Pressure and Timing Change of Velopharynx, Tongue Base, Low Pharynx and Upper Esophageal Sphincter. | Control, pressure of VP, thin | 129.66 mmHg | Standard Deviation 45.58 |
| Experimental Group | Pressure and Timing Change of Velopharynx, Tongue Base, Low Pharynx and Upper Esophageal Sphincter. | Control, pressure of tongue base, thick | 136.40 mmHg | Standard Deviation 27.2 |
| Experimental Group | Pressure and Timing Change of Velopharynx, Tongue Base, Low Pharynx and Upper Esophageal Sphincter. | NMES, pressure of VP, thin | 170.66 mmHg | Standard Deviation 77.1 |
Comparison: Wilcoxon signed rank test was used to compare the Videofluoroscopic swallowing study(VFSS) kinematic variables, VDS, PAS, and high resolution manometry (HRM) variables between the neuromuscular electrical stimulation session and the control session in swallowing thin fluid and thick fluid for healthy, dysphagic and whole participants. Mann-Whitney test was used to compare the differences of VFSS variables, VDS, PAS, and HRM variables between the healthy participants and dysphagic participants.p-value: <0.05Wilcoxon (Mann-Whitney)