Treatment of Dysphagia by Using a Synchronized Electrical Stimulation Device

Seoul National University

Status: Completed

Conditions: Deglutition Disorders

Treatments: Device: Synchronized Electrical Stimulation Device

Study type: Interventional

Funder types: Other

Identifiers

NCT02718963

B-1507/306-002

Details and patient eligibility

About

The purpose of this study is to determine the synchronized electrical stimulation device effective in the treatment of dysphagia.

Full description

• Design: Prospective study
• Inclusion criteria of the patient group: who has a dysphagia symptom and confirmed by video-fluoroscopic swallowing study(N=10)
• Inclusion criteria of the control group: who does not have any dysphagia symptoms, and does not have any underlying disease(N=10)
• Setting: Hospital rehabilitation department
• Intervention: Participants are applied electrical stimulation by a "Synchronized Electrical Stimulation Device(SESD)"

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• who have dysphagia symptoms and verified deglutition disorder by video fluoro swallowing study

Exclusion criteria

• who reject the checkup their deglutition function by high resolution manometry
• who reject apply "Synchronized Electrical Stimulator"

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Control group

Experimental group

Description:

* control group(N=10): who does not have dysphagia symptom * apply Synchronized Electrical Stimulation Device * before apply the synchronized electrical stimulation device, we will evaluate the high resolution manometry for evaluation of deglutition function * during apply the synchronized electrical stimulation device, we will evaluate the high resolution manometry for evaluation of deglutition function

Treatment:

Device: Synchronized Electrical Stimulation Device

Experimental group

Experimental group

Description:

* experimental group(N=10): who have dysphagia symptoms * apply Synchronized Electrical Stimulation Device * before apply the synchronized electrical stimulation device, we will evaluate the high resolution manometry for evaluation of deglutition function * during apply the synchronized electrical stimulation device, we will evaluate the high resolution manometry for evaluation of deglutition function

Treatment:

Device: Synchronized Electrical Stimulation Device