Assess the Safety and Efficacy of the 4 Channel NMES, Pilot Study

Seoul National University

Status: Terminated

Conditions: Dysphagia

Treatments: Device: 4 channel Electrical Stimulation Device

Study type: Interventional

Funder types: Other

Identifiers

NCT03664479

E-1706/402-001

Details and patient eligibility

About

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 effect by the electric stimulation method 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.

Full description

• Design: Prospective study
• Inclusion criteria of patient group: who has a dysphagia symptom and confirmed by video-fluoroscopic swallowing study(N=9)
• Intervention: Participants are divided into two group and applied electrical stimulation by a "Synchronized Electrical Stimulation Device(SESD)" in different protocol
• Main outcome measures: high-resolution manometry(HRM) parameters, videofluoroscopic parameters, EQ-5D (EuroQoL-5D) questionnaire

Enrollment: 4 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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4 participants in 2 patient groups

classical electrical stimulation protocol

Experimental group

Description:

* apply 4 channel electrical stimulation device with protocol 1. * It will simultaneously stimulate suprahyoid, thyrohyoid and sternothyroid m with 4 channel electrical stimulation device. * during apply the device, we evaluate the manometry and videofluoroscopic swallowing study for evaluation of deglutition function.

Treatment:

Device: 4 channel Electrical Stimulation Device

revised sequential activation protocol

Experimental group

Description:

* apply 4 channel electrical stimulation device with protocol 2 * Is a revised sequential activation protocol, it sequentially stimulate bilateral suprahyoid m (channel 1), pharyngeal constrictors (ch 2), thyrohyoid m (ch 3), sternothyroid m (ch 4) with 4 channel electrical stimulation device. * during apply the synchronized electrical stimulation device, we will evaluate the parameters same as group 1.

Treatment:

Device: 4 channel Electrical Stimulation Device