A Double-blind, Parallel Compensatory Medical Device Pivotal Clinical Study to Assess the Safety and Efficacy of the 4 Channel Neuromuscular Electrical Stimulation (NMES), Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 4
- Locations
- 2
- Primary Endpoint
- pressure change
Study Overview
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 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.
Detailed 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
classical electrical stimulation protocol
- 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.
Intervention: 4 channel Electrical Stimulation Device (Device)
revised sequential activation protocol
- 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.
Intervention: 4 channel Electrical Stimulation Device (Device)
Outcomes
Primary Outcomes
pressure change
Time Frame: 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.)
videofluoroscopic dysphagia scale
Time Frame: 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.
total score 100 from 0, 100 is worst outcome
Secondary Outcomes
No secondary outcomes reported
Investigators
Ju Seok Ryu
associate professor
Seoul National University Hospital