Clinical trial NCT03670498: The Safety and Efficacy of the 4 Channel NMES on Swallowing
Official title: A Double-blind, Parallel Cumulative Medical Device Pivotal Clinical Study to Assess the Safety and Efficacy of the 4 Channel NMES, Multi-center Prospective Study (Pilot Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysphagia
Keywords: stroke
cervical spinal cord injury
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-09-13
Enrollment: 26
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 4ch NMES and 2ch NMES, 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.

Detailed description: * Design: Prospective study
* Inclusion criteria of patient group: who has a dysphagia symptom and confirmed by video-fluoroscopic swallowing study
* Intervention: Participants are divided into two group and applied electrical stimulation by a "Synchronized Electrical Stimulation Device(SESD)" in 4channel or 2channel Neuromuscular Electrical Stimulation.
* Main outcome measures: videofluoroscopic parameters, EQ-5D (EuroQoL-5D) questionnaire, II. M. D Anderson dysphagia inventory

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

Primary outcomes:
measure: videofluoroscopic dysphagia scale
timeFrame: baseline/ change from baseline when electrical stimulation applied(the object of this study is to know the temporary change of dysphagia when stimulating with 4ch NMES.
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Kyungji-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Ju Seok Ryu, M.D. PhD
role: STUDY_DIRECTOR
References:
citation: Seo KH, Jang J, Jang EG, Park Y, Lee SY, Kim BR, Park D, Park S, Hwang H, Kim NH, Oh BM, Seo HG, Lee JC, Ryu JS. Clinical effectiveness of the sequential 4-channel NMES compared with that of the conventional 2-channel NMES for the treatment of dysphagia in a prospective double-blind randomized controlled study. J Neuroeng Rehabil. 2021 May 31;18(1):90. doi: 10.1186/s12984-021-00884-6.