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

Primary Purpose

Dysphagia

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

4 channel Electrical Stimulation Device

About this trial

This is an interventional treatment trial for Dysphagia focused on measuring stroke, cervical spinal cord injury

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Seoul national university bundang hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Revised sequential activation protocol

control subject

Arm Description

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.

Apply 4 channel electrical stimulation device without any stimulation

Outcomes

Primary Outcome Measures

The Modified Barium Swallow Impairment Profile (MBSImP™©)

total score 0 from 55, 55 is worst outcome

Secondary Outcome Measures

Full Information

NCT ID

NCT03670485

First Posted

September 12, 2018

Last Updated

July 31, 2020

Sponsor

Seoul National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03670485

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

June 1, 2019 (Actual)

Primary Completion Date

February 21, 2020 (Actual)

Study Completion Date

February 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dysphagia

Keywords

stroke, cervical spinal cord injury

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

51 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Revised sequential activation protocol

Arm Type

Experimental

Arm Description

Arm Title

control subject

Arm Type

No Intervention

Arm Description

Apply 4 channel electrical stimulation device without any stimulation

Intervention Type

Device

Intervention Name(s)

4 channel Electrical Stimulation Device

Intervention Description

electrical stimulation at muscles which related with deglutition

Primary Outcome Measure Information:

Title

Description

total score 0 from 55, 55 is worst outcome

Time Frame

Change from Baseline without stimulation at within 1 weeks with electrical stimulation applied

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jusuk Ryu, M.D. PhD

Organizational Affiliation

Seoul National University Bundang Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Seoul national university bundang hospital

City

Seongnam-si

State/Province

Bundang

ZIP/Postal Code

13364

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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