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

Not Applicable

Completed

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

• Registration Number: NCT03670485
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

Detailed Description

* 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

Study Timeline

• Study First Submitted: 2018-09-12
• Study First Submitted QC: 2018-09-12
• Study First Posted: 2018-09-13
• Study Start: 2019-06-01
• Primary Completion: 2020-02-21
• Study Completion: 2020-02-21
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-31
• Last Update Posted: 2020-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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
Revised sequential activation protocol	4 channel Electrical Stimulation Device	Apply 4 channel electrical stimulation device with a revised sequential activation protocol. It sequentially activates Rt. suprahyoid m (ch 1), Lt. suprahyoid m (ch 2), thyrohyoid m (ch 3), sternothyroid m (ch 4) with 4 channel electrical stimulation device.

Primary Outcome Measures

Name	Time	Method
The Modified Barium Swallow Impairment Profile (MBSImP™©)	Change from Baseline without stimulation at within 1 weeks with electrical stimulation applied	total score 0 from 55, 55 is worst outcome

Trial Locations

Locations (1)

Seoul national university bundang hospital; 🇰🇷 Seongnam-si, Bundang, Korea, Republic of