The Safety and Efficacy of the 4 Channel NMES on Swallowing

Not Applicable

Completed

• Conditions: Dysphagia
• Interventions: Device: 4 channel Electrical Stimulation Device; Device: 2 channel Electrical Stimulation Device

• Registration Number: NCT03670498
• Lead Sponsor: Seoul National University Hospital

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 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.

Detailed Description

* Design: Prospective study

* Inclusion criteria of patient group: who has a dysphagia symptom and confirmed by video-fluoroscopic swallowing study

* Intervention: Participants are divided into two group and applied electrical stimulation by a "Synchronized Electrical Stimulation Device(SESD)" in 4channel or 2channel Neuromuscular Electrical Stimulation.

* Main outcome measures: videofluoroscopic parameters, EQ-5D (EuroQoL-5D) questionnaire, II. M. D Anderson dysphagia inventory

Study Timeline

• Study First Submitted: 2018-09-12
• Study First Submitted QC: 2018-09-12
• Study First Posted: 2018-09-13
• Study Start: 2018-10-01
• Primary Completion: 2019-08-04
• Study Completion: 2019-08-04
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-22
• Last Update Posted: 2020-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4 channel Electrical Stimulation(revised sequential)	4 channel Electrical Stimulation Device	apply 4 channel electrical stimulation device with protocol Is a revised sequential activation protocol, it sequentially Rt. suprahyoid m (ch 1), Lt. suprahyoid m (ch 2), thyrohyoid m (ch 3), sternothyroid m (ch 4) with 4 channel electrical stimulation device.
2 channel Electrical Stimulation(classical)	2 channel Electrical Stimulation Device	apply 2 channel electrical stimulation device with protocol Is a revised sequential activation protocol, it simultaneously suprahyoid m (ch 1), thyrohyoid m (ch 2) with 2 channel electrical stimulation device.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Kyungji-do, Korea, Republic of