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

Seoul National University

Status: Completed

Conditions: Dysphagia

Treatments: Device: 4 channel Electrical Stimulation Device

Study type: Interventional

Funder types: Other

Identifiers

NCT03670485

E-1806-475-001

Details and patient eligibility

About

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.

Full 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

Enrollment: 51 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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51 participants in 2 patient groups

Revised sequential activation protocol

Experimental group

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.

Treatment:

Device: 4 channel Electrical Stimulation Device

control subject

No Intervention group

Description:

Apply 4 channel electrical stimulation device without any stimulation