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Clinical Trial for Clinical Excellence and Safety Evaluation of 4-channel Functional Electric Stimulator

Primary Purpose

Dysphagia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
4-channel Electrical Stimulation Device
2-channel Electrical Stimulation Device
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysphagia

Eligibility Criteria

19 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients with oropharyngeal dysphagia confirmed by video fluoroscopy
  • Patients with oropharyngeal dysphagia due to central nervous system disease who clinically require application of an electrical stimulation treatment device for dysphagia
  • Patients aged between 19 and under 90 years of age regardless of gender
  • Those who voluntarily consent to the clinical trial and can visit for the next observation
  • Patients with dysphagia within 6 months (including patients with dysphagia due to stroke, traumatic brain injury, cervical spine injury, etc.)

Exclusion Criteria:

  • In case of refusal of inspection
  • Who do not agree
  • When instructions cannot be performed due to mental illness, etc.
  • Those who have dysphagia due to respiratory failure, cervical spine surgery, head and neck surgery, and chemotherapy and radiation treatment of the neck
  • Pregnant and lactating women
  • 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.
  • Patients who cannot apply electrical stimulation therapy due to allergies or hypersensitivity reactions
  • 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
  • Persons with pacemakers and other internal electrical stimulators
  • Those who are participating in other clinical trials at the time of screening
  • Those who are judged by other researchers to be inappropriate for this clinical trial

Sites / Locations

  • Department of Rehabilitation Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

classical electrical stimulation protocol (control group)

revised sequential activation protocol (experimental group)

Arm Description

Apply 2-channel electrical stimulation device with protocol 1. It will simultaneously stimulate bilateral suprahyoid, bilateral thyrohyoid muscle with 2-channel electrical stimulation device. Basic intervention involves 600-900 minutes of electrical stimulation for 2 weeks. (based on 60 minutes per 1 time, applied 10 times(+5 times, within 1 week)) With the consent of the patient, an additional evaluation is performed after additional 2 weeks of intervention, which is use as an exploratory indicator. After application of the device, we evaluate videofluoroscopic swallowing study(VFSS) for evaluation of swallowing function. In addition, we evaluate clinical questionnaires(FOIS, MDADI, Likert scale), nutritional status assessments(MNA-SF), and oral intake assessments. Also, we measure tongue strength through IOPI and body composition changes through Inbody.

Apply 4-channel electrical stimulation device with protocol 2. It sequentially stimulates bilateral suprahyoid muscle(ch 1, ch 2), bilateral thyrohyoid muscle(ch 3), bilateral sternothyroid muscle(ch 4) with 4-channel electrical stimulation device. Basic intervention involves 600-900 minutes of electrical stimulation for 2 weeks. (based on 60 minutes per 1 time, applied 10 times(+5 times, within 1 week)) With the consent of the patient, an additional evaluation is performed after additional 2 weeks of intervention, which is use as an exploratory indicator. After application of the device, we evaluate videofluoroscopic swallowing study(VFSS) for evaluation of swallowing function. In addition, we evaluate clinical questionnaires(FOIS, MDADI, Likert scale), nutritional status assessments(MNA-SF), and oral intake assessments. Also, we measure tongue strength through IOPI and body composition changes through Inbody.

Outcomes

Primary Outcome Measures

Comparison of VDS total change
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
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
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
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
Exploratory observation of the effect of electrical stimulation therapy on tongue strength through IOPI, comparison of fluctuation values of body composition through Bioelectrical Impendance Analysis (BIA; InBody), measurement of changes in oral intake and malnutrition index before and after intervention and MNA-SF questionnaire do.

Full Information

First Posted
November 1, 2021
Last Updated
August 2, 2023
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05483582
Brief Title
Clinical Trial for Clinical Excellence and Safety Evaluation of 4-channel Functional Electric Stimulator
Official Title
Clinical Trial to Evaluate the Efficacy and Safety of a 4-channel Swallowing Function Electrical Stimulation Device Compared to a 2-channel Swallowing Function Electrical Stimulation Device for the Rehabilitation Mechanism
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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 different protocol Main outcome measures: Videofluoroscopic Dysphagia Scale (VDS), Penetration 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. Secondary outcome measures: Verifying the safety of functional electric stimulation therapy device for dysphagia, measuring the effect on Tongue Strength through IOPI, the effect on changes in body composition through Bioelectrical Impedance Analysis (BIA; InBody S10, InBody, Inc.), and whether there is a significant change in actual patient intake and nutritional status through oral intake survey and MNA-SF measure. An exploratory comparison of intervention effects over time between 2-week and 4-week interventions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
classical electrical stimulation protocol (control group)
Arm Type
Active Comparator
Arm Description
Apply 2-channel electrical stimulation device with protocol 1. It will simultaneously stimulate bilateral suprahyoid, bilateral thyrohyoid muscle with 2-channel electrical stimulation device. Basic intervention involves 600-900 minutes of electrical stimulation for 2 weeks. (based on 60 minutes per 1 time, applied 10 times(+5 times, within 1 week)) With the consent of the patient, an additional evaluation is performed after additional 2 weeks of intervention, which is use as an exploratory indicator. After application of the device, we evaluate videofluoroscopic swallowing study(VFSS) for evaluation of swallowing function. In addition, we evaluate clinical questionnaires(FOIS, MDADI, Likert scale), nutritional status assessments(MNA-SF), and oral intake assessments. Also, we measure tongue strength through IOPI and body composition changes through Inbody.
Arm Title
revised sequential activation protocol (experimental group)
Arm Type
Experimental
Arm Description
Apply 4-channel electrical stimulation device with protocol 2. It sequentially stimulates bilateral suprahyoid muscle(ch 1, ch 2), bilateral thyrohyoid muscle(ch 3), bilateral sternothyroid muscle(ch 4) with 4-channel electrical stimulation device. Basic intervention involves 600-900 minutes of electrical stimulation for 2 weeks. (based on 60 minutes per 1 time, applied 10 times(+5 times, within 1 week)) With the consent of the patient, an additional evaluation is performed after additional 2 weeks of intervention, which is use as an exploratory indicator. After application of the device, we evaluate videofluoroscopic swallowing study(VFSS) for evaluation of swallowing function. In addition, we evaluate clinical questionnaires(FOIS, MDADI, Likert scale), nutritional status assessments(MNA-SF), and oral intake assessments. Also, we measure tongue strength through IOPI and body composition changes through Inbody.
Intervention Type
Device
Intervention Name(s)
4-channel Electrical Stimulation Device
Intervention Description
electrical stimulation at muscles which related with deglutition
Intervention Type
Device
Intervention Name(s)
2-channel Electrical Stimulation Device
Intervention Description
electrical stimulation at muscles which related with deglutition
Primary Outcome Measure Information:
Title
Comparison of VDS total change
Description
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
Time Frame
300 to 600 minutes
Secondary Outcome Measure Information:
Title
Using the results of the video fluoroscopic swallowing test
Description
Comparison of changes in VDS (oral score, pharyngeal score), PAS (Penetration Aspiration Scale) and kinematic analysis using the results of video fluoroscopic swallowing test.
Time Frame
300 to 600 minutes
Title
Results of pre- and post-intervention surveys
Description
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.
Time Frame
30 to 60 minutes
Title
Satisfaction evaluation of treatment device
Description
The Likert scale is used to evaluate the satisfaction with the application of the electric stimulation therapy device of the study subjects.
Time Frame
10 to 30 minutes
Title
Exploratory observation of the effect of electrical stimulation therapy
Description
Exploratory observation of the effect of electrical stimulation therapy on tongue strength through IOPI, comparison of fluctuation values of body composition through Bioelectrical Impendance Analysis (BIA; InBody), measurement of changes in oral intake and malnutrition index before and after intervention and MNA-SF questionnaire do.
Time Frame
30 to 60 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with oropharyngeal dysphagia confirmed by video fluoroscopy Patients with oropharyngeal dysphagia due to central nervous system disease who clinically require application of an electrical stimulation treatment device for dysphagia Patients aged between 19 and under 90 years of age regardless of gender Those who voluntarily consent to the clinical trial and can visit for the next observation Patients with dysphagia within 6 months (including patients with dysphagia due to stroke, traumatic brain injury, cervical spine injury, etc.) Exclusion Criteria: In case of refusal of inspection Who do not agree When instructions cannot be performed due to mental illness, etc. Those who have dysphagia due to respiratory failure, cervical spine surgery, head and neck surgery, and chemotherapy and radiation treatment of the neck Pregnant and lactating women 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. Patients who cannot apply electrical stimulation therapy due to allergies or hypersensitivity reactions 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 Persons with pacemakers and other internal electrical stimulators Those who are participating in other clinical trials at the time of screening Those who are judged by other researchers to be inappropriate for this clinical trial
Facility Information:
Facility Name
Department of Rehabilitation Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juseok Ryu, M.D, PhD
Phone
+82-31-787-7739
Email
jseok337@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Seungwoo Lee, CRA
Phone
+82-5181-8066
Email
r4105@snubh.org

12. IPD Sharing Statement

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Clinical Trial for Clinical Excellence and Safety Evaluation of 4-channel Functional Electric Stimulator

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