To Assess the Safety and Efficacy of the 4 Channel NMES Compensatory Medical Device in Swallowing, Multicenter Study

A Prospective Study of Compensatory Medical Device Pivotal Clinical Study to Assess the Safety and Efficacy of the 4 Channel NMES, Multicenter Study

This study is a confirmation 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 validate the 4ch NMES device.

• Design: Prospective study
• Inclusion criteria of patient group: who has a dysphagia symptom and confirmed by video-fluoroscopic swallowing study
• Intervention: applied electrical stimulation by a "Synchronized Electrical Stimulation Device(SESD)"
• Main outcome measures: videofluoroscopic parameters, EQ-5D (EuroQoL-5D) questionnaire, II. M. D Anderson dysphagia inventory

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