To Assess the Safety and Efficacy of the 4 Channel NMES Compensatory Medical Device in Swallowing, Multicenter Study
NCT ID: NCT03670485
Last Updated: 2020-08-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
51 participants
INTERVENTIONAL
2019-06-01
2020-02-21
Brief Summary
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Detailed Description
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* 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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Revised sequential activation protocol
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.
4 channel Electrical Stimulation Device
electrical stimulation at muscles which related with deglutition
control subject
Apply 4 channel electrical stimulation device without any stimulation
No interventions assigned to this group
Interventions
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4 channel Electrical Stimulation Device
electrical stimulation at muscles which related with deglutition
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
19 Years
ALL
Yes
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Ju Seok Ryu
associate professor
Principal Investigators
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Jusuk Ryu, M.D. PhD
Role: STUDY_DIRECTOR
Seoul National University Bundang Hospital
Locations
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Seoul national university bundang hospital
Seongnam-si, Bundang, South Korea
Countries
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Other Identifiers
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E-1806-475-001
Identifier Type: -
Identifier Source: org_study_id
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