Assess the Safety and Efficacy of the 4 Channel NMES, Pilot Study
NCT03664479 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4
Last updated 2018-09-14
Summary
This study is a pilot study to prepare clinical trials to evaluate the safety and effectiveness of 4-channel electric stimulation therapy devices as a newly developed function for the treatment of dysphagia disorders.
The purpose of this study is to investigate the difference in effect by the electric stimulation method and to obtain the values such as mean, standard deviation and so on, and to determine the number of subjects to be studied for clinical trials of validation permission in the future.
Conditions
Interventions
- DEVICE
-
4 channel Electrical Stimulation Device
electrical stimulation at muscles which related with deglutition
Sponsors & Collaborators
-
Seoul National University Hospital
lead OTHER
Principal Investigators
-
Jusuk Ryu, M.D. PhD · Seoul National University Bundang Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 19 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2018-03-01
- Primary Completion
- 2018-06-01
- Completion
- 2018-06-01
Countries
- South Korea
Study Locations
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