Clinical Trial for Clinical Excellence and Safety Evaluation of 4-channel Functional Electric Stimulator
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
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Design: Prospective study
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Inclusion criteria of patient group: who has a dysphagia symptom and confirmed by video-fluoroscopic swallowing study(N=4)
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Intervention: Participants are divided into two group and applied electrical stimulation by a "Synchronized Electrical Stimulation Device(SESD)" in different protocol
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Main outcome measures: Videofluoroscopic Dysphagia Scale (VDS), Pene-tration aspiration scale (PAS),Measured by kinematic metaphysical analysis. The dietary status of the subjects was evaluated by the Functional Oral Intake Scale (FOIS), and the M.D anderson dysphagia inventory was used to measure the diet-related quality of life. The Likert scale is used to evaluate the satisfaction with the application of the electric stimulation therapy device of the study subjects.
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Secondary outcome measures: Verifying the safety of functional electric stimulation therapy device for dysphagia, Measuring the effect on Tongue Strength through IOPI and whether there is a significant change in actual patient intake and nutritional status through 24-hour Dietary Recall and MNA-SF.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: classical electrical stimulation protocol apply 2 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. The control group is evaluated after intervention only once with the electrical stimulation treatment device removed. |
Other: 2 channel Electrical Stimulation Device
electrical stimulation at muscles which related with deglutition
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| Experimental: 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. For additional exploratory research, only those who do not have severe disability in the experimental group and who can perform 1-step commands, after the intervention, with 4-channel electrical stimulation device attached, once with the 4-channel electrical stimulation device attached, once with the release state, a total of 2 Perform a VFSS test twice. In addition, the experimental group, who cannot perform 1-step commands due to severe cognitive impairment, conducts evaluation after intervention only once with the electrical stimulation treatment device off. |
Device: 4 channel Electrical Stimulation Device
electrical stimulation at muscles which related with deglutition
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Outcome Measures
Primary Outcome Measures
- Comparison of VDS total change [300 to 600 minutes]
Comparison of VDS total change between the two groups using the results of the video fluoroscopic swallowing test between the experimental group and the control group
Secondary Outcome Measures
- Using the results of the video fluoroscopic swallowing test [300 to 600 minutes]
Comparison of changes in VDS (oral score, pharyngeal score), PAS (Penetration Aspiration Scale) and kinematic analysis using the results of video fluoroscopic swallowing test.
- Results of pre- and post-intervention surveys [30 to 60 minutes]
The dietary status of the subjects was evaluated by the Functional Oral Intake Scale (FOIS), and the M.D anderson dysphagia inventory was used to measure the diet-related quality of life.
- Satisfaction evaluation of treatment device [10 to 30 minutes]
The Likert scale is used to evaluate the satisfaction with the application of the electric stimulation therapy device of the study subjects.
- Exploratory observation of the effect of electrical stimulation therapy [30 to 60 minutes]
Exploratory observation of the effect of electrical stimulation therapy on tongue strength through IOPI, and measurement of changes in oral intake and malnutrition index through 24-hour Dietary Recall before and after intervention and MNA-SF questionnaire do.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with oropharyngeal dysphagia confirmed by video fluoroscopy
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Patients with oropharyngeal dysphagia due to central nervous system disease who clinically require application of an electrical stimulation treatment device for dysphagia
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Patients aged between 19 and under 90 years of age regardless of gender
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Those who voluntarily consent to the clinical trial and can visit for the next observation
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Patients with dysphagia within 6 months (including patients with dysphagia due to stroke, traumatic brain injury, cervical spine injury, etc.)
Exclusion Criteria:
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In case of refusal of inspection
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Who do not agree
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When instructions cannot be performed due to mental illness, etc.
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Those who have dysphagia due to respiratory failure, cervical spine surgery, head and neck surgery, and chemotherapy and radiation treatment of the neck
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Pregnant and lactating women
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Pre-interview is conducted only with women of childbearing age to determine whether they are pregnant or lactating. If pregnancy is confirmed during the pre-interview, it is excluded from the test.
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Patients who cannot apply electrical stimulation therapy due to allergies or hypersensitivity reactions
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Others who have comorbidities (e.g., malignant tumors, severe renal/liver/lung diseases, blood clotting abnormalities, etc.) that are inappropriate for participation in clinical trials as judged by the researcher
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Persons with pacemakers and other internal electrical stimulators
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Those who are participating in other clinical trials at the time of screening
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Those who are judged by other researchers to be inappropriate for this clinical trial
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Rehabilitation Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine | Seongnam-si | Gyeonggi-do | Korea, Republic of | 463-707 |
Sponsors and Collaborators
- Seoul National University Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- E-2103/672-001