Trial Outcomes & Findings for Treatment of Dysphagia by Using a Synchronized Electrical Stimulation Device (NCT NCT02718963)

Last Updated: 2020-11-12

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

During the electrical stimulation and electrical stimulation effects of Velopharynx, tongue base, lower pharynx and upper esophageal sphincter

Results posted on

2020-11-12

Participant Flow

There was no significant event in the study after participant enrollment

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	10	10
Overall Study COMPLETED	9	9
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control Group n=10 Participants * 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	Experimental Group n=10 Participants * 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	Total n=20 Participants Total of all reporting groups
Age, Continuous	51.6 years STANDARD_DEVIATION 11.99 • n=10 Participants	65.9 years STANDARD_DEVIATION 13.06 • n=10 Participants	58.75 years STANDARD_DEVIATION 12.5 • n=20 Participants
Sex: Female, Male Female	4 Participants n=10 Participants	2 Participants n=10 Participants	6 Participants n=20 Participants
Sex: Female, Male Male	6 Participants n=10 Participants	8 Participants n=10 Participants	14 Participants n=20 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment South Korea	10 participants n=10 Participants	10 participants n=10 Participants	20 participants n=20 Participants
Disease Stroke	0 Participants n=10 Participants	4 Participants n=10 Participants	4 Participants n=20 Participants
Disease Brain tumor	0 Participants n=10 Participants	1 Participants n=10 Participants	1 Participants n=20 Participants
Disease Cerebral palsy	0 Participants n=10 Participants	1 Participants n=10 Participants	1 Participants n=20 Participants
Disease Guillain-Barre syndrome	0 Participants n=10 Participants	1 Participants n=10 Participants	1 Participants n=20 Participants
Disease Spinal cord injury	0 Participants n=10 Participants	1 Participants n=10 Participants	1 Participants n=20 Participants
Disease Unknown	0 Participants n=10 Participants	2 Participants n=10 Participants	2 Participants n=20 Participants
Disease Healthy	10 Participants n=10 Participants	0 Participants n=10 Participants	10 Participants n=20 Participants

PRIMARY outcome

Timeframe: During the electrical stimulation and electrical stimulation effects of Velopharynx, tongue base, lower pharynx and upper esophageal sphincter

Outcome measures

Outcome measures
Measure	Control Group n=10 Participants * 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	Experimental Group n=10 Participants * 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
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	129.66 mmHg Standard Deviation 45.58
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	170.66 mmHg Standard Deviation 77.10
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	136.40 mmHg Standard Deviation 27.20
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	151.26 mmHg Standard Deviation 34.86

Adverse Events

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Experimental Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ju Seok Ryu

Seoul National University Bundang Hospital, Seoul National University College of Medicine

Phone: 82-31-787-7739

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place