Dysphagia Clinical Trial
Official title:
A Double-blind, Parallel Cumulative Medical Device Pivotal Clinical Study to Assess the Safety and Efficacy of the 4 Channel NMES, Multi-center Prospective Study (Pilot Study)
Verified date | July 2020 |
Source | Seoul National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 4ch NMES and 2ch NMES, 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.
Status | Completed |
Enrollment | 26 |
Est. completion date | August 4, 2019 |
Est. primary completion date | August 4, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 19 Years and older |
Eligibility |
Inclusion Criteria: - patient who do not belong to the criteria excluded for subjects aged 19 years or older - Patient who is confirmed to be dysphagia by videofluoroscopy - Patients who need clinical application of electrical stimulation therapy equipment for dysphagia. ex) stroke, cervical spinal cord injury - Those voluntarily agreeing to the clinical trial Exclusion Criteria: - Patient who refuse inspection, do not agree - Simple "Commend obey", first step is impossible - When instructions can not be executed due to dementia, psychiatric disorders, etc. - Dysphagia occurs due to respiratory failure, neck surgery, etc., - Pregnant women and lactating women |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Bundang Hospital | Seongnam-si | Kyungji-do |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | videofluoroscopic dysphagia scale | total score 100 from 0, 100 is worst outcome | baseline/ change from baseline when electrical stimulation applied(the object of this study is to know the temporary change of dysphagia when stimulating with 4ch NMES. |
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