An interventional study of 4-channel Electrical Stimulation Device and 2-channel Electrical Stimulation Device in Dysphagia, sponsored by Seoul National University Hospital. Recruiting at 1 site in Korea, Republic of. Open to participants aged 19 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-22.
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.
710 studies on the registry are indexed under Deglutition Disorders; 219 are open to participants now.
This study's planned enrollment of 68 is above the median of 60 across 471 interventional studies indexed under Deglutition Disorders.
Browse Deglutition Disorders studies →Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 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 2-channel electrical stimulation device with protocol 1. * It will simultaneously stimulate bilateral suprahyoid, bilateral thyrohyoid muscle with 2-channel electrical stimulation device. * Basic intervention involves 600-900 minutes of electrical stimulation for 2 weeks. (based on 60 minutes per 1 time, applied 10 times(+5 times, within 1 week)) * With the consent of the patient, an additional evaluation is performed after additional 2 weeks of intervention, which is use as an exploratory indicator. * After application of the device, we evaluate videofluoroscopic swallowing study(VFSS) for evaluation of swallowing function. * In addition, we evaluate clinical questionnaires(FOIS, MDADI, Likert scale), nutritional status assessments(MNA-SF), and oral intake assessments. * Also, we measure tongue strength through IOPI and body composition changes through Inbody.
Device: 2-channel Electrical Stimulation Device
* Apply 4-channel electrical stimulation device with protocol 2. * It sequentially stimulates bilateral suprahyoid muscle(ch 1, ch 2), bilateral thyrohyoid muscle(ch 3), bilateral sternothyroid muscle(ch 4) with 4-channel electrical stimulation device. * Basic intervention involves 600-900 minutes of electrical stimulation for 2 weeks. (based on 60 minutes per 1 time, applied 10 times(+5 times, within 1 week)) * With the consent of the patient, an additional evaluation is performed after additional 2 weeks of intervention, which is use as an exploratory indicator. * After application of the device, we evaluate videofluoroscopic swallowing study(VFSS) for evaluation of swallowing function. * In addition, we evaluate clinical questionnaires(FOIS, MDADI, Likert scale), nutritional status assessments(MNA-SF), and oral intake assessments. * Also, we measure tongue strength through IOPI and body composition changes through Inbody.
Device: 4-channel Electrical Stimulation Device
electrical stimulation at muscles which related with deglutition
electrical stimulation at muscles which related with deglutition
Comparison of VDS total change
Comparison of VDS total change between the two groups using the results of the video fluoroscopic swallowing test between the experimental group and the control group
Time frame: 300 to 600 minutes
Using the results of the video fluoroscopic swallowing test
Comparison of changes in VDS (oral score, pharyngeal score), PAS (Penetration Aspiration Scale) and kinematic analysis using the results of video fluoroscopic swallowing test.
Time frame: 300 to 600 minutes
Results of pre- and post-intervention surveys
The dietary status of the subjects was evaluated by the Functional Oral Intake Scale (FOIS), and the M.D anderson dysphagia inventory was used to measure the diet-related quality of life.
Time frame: 30 to 60 minutes
Satisfaction evaluation of treatment device
The Likert scale is used to evaluate the satisfaction with the application of the electric stimulation therapy device of the study subjects.
Time frame: 10 to 30 minutes
Exploratory observation of the effect of electrical stimulation therapy
Exploratory observation of the effect of electrical stimulation therapy on tongue strength through IOPI, comparison of fluctuation values of body composition through Bioelectrical Impendance Analysis (BIA; InBody), measurement of changes in oral intake and malnutrition index before and after intervention and MNA-SF questionnaire do.
Time frame: 30 to 60 minutes
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Seoul National University Hospital