Dysphagia
Conditions
Keywords
stroke, cervical spinal cord injury
Brief 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.
Detailed description
* Design: Prospective study * Inclusion criteria of patient group: who has a dysphagia symptom and confirmed by video-fluoroscopic swallowing study(N=9) * Intervention: Participants are divided into two group and applied electrical stimulation by a Synchronized Electrical Stimulation Device(SESD) in different protocol * Main outcome measures: high-resolution manometry(HRM) parameters, videofluoroscopic parameters, EQ-5D (EuroQoL-5D) questionnaire
Interventions
electrical stimulation at muscles which related with deglutition
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pressure change | 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.) | — |
| videofluoroscopic dysphagia scale | 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. | total score 100 from 0, 100 is worst outcome |
Countries
South Korea
Outcome results
None listed