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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Dysphagia
• Intervention / Treatment: Device: 2-channel Electrical Stimulation Device; Device: 4-channel Electrical Stimulation Device

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.

• Study Type: Interventional
• Enrollment (Estimated): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
      • Recruiting
      • Department of Rehabilitation Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine
      • Contact: Juseok Ryu, M.D, PhD; Phone Number: +82-31-787-7739; Email: jseok337@snu.ac.kr
      • Contact: Seungwoo Lee, CRA; Phone Number: +82-5181-8066; Email: r4105@snubh.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: classical electrical stimulation protocol (control group); 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.	Device: 2-channel Electrical Stimulation Device; electrical stimulation at muscles which related with deglutition
Experimental: revised sequential activation protocol (experimental group); 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.	Device: 4-channel Electrical Stimulation Device; electrical stimulation at muscles which related with deglutition

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	300 to 600 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	300 to 600 minutes
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.	30 to 60 minutes
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.	10 to 30 minutes
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.	30 to 60 minutes

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: November 1, 2021
• First Submitted That Met QC Criteria: August 1, 2022
• First Posted (Actual): August 2, 2022

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Deglutition Disorders
• Other Study ID Numbers: E-2103-672-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No