An interventional study of 4 channel Electrical Stimulation Device in Dysphagia, sponsored by Seoul National University Hospital. Terminated at 1 site in South Korea. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-14.
Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Treatment
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.
723 studies on the registry are indexed under Deglutition Disorders; 219 are open to participants now.
This study's enrollment of 4 is below the median of 60 across 482 interventional studies indexed under Deglutition Disorders.
Browse Deglutition Disorders studies →Seoul National University Hospital is the lead sponsor of 1,897 studies on the registry; 273 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
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Exclusion Criteria:
* apply 4 channel electrical stimulation device with protocol 1. * It will simultaneously stimulate suprahyoid, thyrohyoid and sternothyroid m with 4 channel electrical stimulation device. * during apply the device, we evaluate the manometry and videofluoroscopic swallowing study for evaluation of deglutition function.
Device: 4 channel Electrical Stimulation Device
* apply 4 channel electrical stimulation device with protocol 2 * Is a revised sequential activation protocol, it sequentially stimulate bilateral suprahyoid m (channel 1), pharyngeal constrictors (ch 2), thyrohyoid m (ch 3), sternothyroid m (ch 4) with 4 channel electrical stimulation device. * during apply the synchronized electrical stimulation device, we will evaluate the parameters same as group 1.
Device: 4 channel Electrical Stimulation Device
electrical stimulation at muscles which related with deglutition
pressure change
Time frame: 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
total score 100 from 0, 100 is worst outcome
Time frame: 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.
This study is terminated, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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