Treatment of Dysphagia by Using a Synchronized Electrical Stimulation Device
1 other identifier
interventional
20
1 country
1
Brief Summary
The purpose of this study is to determine the synchronized electrical stimulation device effective in the treatment of dysphagia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 15, 2015
CompletedFirst Submitted
Initial submission to the registry
March 20, 2016
CompletedFirst Posted
Study publicly available on registry
March 24, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 24, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 24, 2016
CompletedResults Posted
Study results publicly available
November 12, 2020
CompletedNovember 12, 2020
October 1, 2020
12 months
March 20, 2016
July 23, 2019
October 20, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Control group
EXPERIMENTAL* 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
Experimental group
EXPERIMENTAL* 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
Interventions
electrical stimulation at muscles which related with deglutition
Eligibility Criteria
You may qualify if:
- who have dysphagia symptoms and verified deglutition disorder by video fluoro swallowing study
You may not qualify if:
- who reject the checkup their deglutition function by high resolution manometry
- who reject apply "Synchronized Electrical Stimulator"
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Rehabilitation Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine
Seongnam-si, Gyeonggi-do, 463-707, South Korea
Related Publications (2)
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.
PMID: 31180928RESULTLim 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.
PMID: 39049019DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
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.
Results Point of Contact
- Title
- Ju Seok Ryu
- Organization
- Seoul National University Bundang Hospital, Seoul National University College of Medicine
Study Officials
- STUDY DIRECTOR
Jusuk Ryu, M.D. PhD
Seoul National University Bundang Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- associate professor
Study Record Dates
First Submitted
March 20, 2016
First Posted
March 24, 2016
Study Start
July 15, 2015
Primary Completion
June 24, 2016
Study Completion
June 24, 2016
Last Updated
November 12, 2020
Results First Posted
November 12, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share