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Clinical Trial for Clinical Excellence and Safety Evaluation of 4-channel Functional Electric Stimulator
Sponsor: Seoul National University Hospital
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.
Official title: Clinical Trial to Evaluate the Efficacy and Safety of a 4-channel Swallowing Function Electrical Stimulation Device Compared to a 2-channel Swallowing Function Electrical Stimulation Device for the Rehabilitation Mechanism
Key Details
Gender
All
Age Range
19 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
68
Start Date
2023-09-01
Completion Date
2025-12-31
Last Updated
2024-04-22
Healthy Volunteers
Yes
Conditions
Interventions
4-channel Electrical Stimulation Device
electrical stimulation at muscles which related with deglutition
2-channel Electrical Stimulation Device
electrical stimulation at muscles which related with deglutition
Locations (1)
Department of Rehabilitation Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine
Seongnam-si, Gyeonggi-do, South Korea