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

NCT05483582 | Recruiting

• 1 other identifier: E-2103-672-001
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysphagia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Using the results of the video fluoroscopic swallowing test

  300 to 600 minutes

• Results of pre- and post-intervention surveys

  30 to 60 minutes

• Satisfaction evaluation of treatment device

  10 to 30 minutes

• Exploratory observation of the effect of electrical stimulation therapy

  30 to 60 minutes

Study Arms (2)

classical electrical stimulation protocol (control group)

ACTIVE COMPARATOR

* 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

revised sequential activation protocol (experimental group)

EXPERIMENTAL

* 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

Interventions

4-channel Electrical Stimulation Device DEVICE

electrical stimulation at muscles which related with deglutition

revised sequential activation protocol (experimental group)

2-channel Electrical Stimulation Device DEVICE

electrical stimulation at muscles which related with deglutition

classical electrical stimulation protocol (control group)

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

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

Seongnam-si, Gyeonggi-do, 463-707, South Korea

RECRUITING

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 1, 2021
• First Posted: August 2, 2022
• Study Start: September 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: April 22, 2024

Record last verified: 2024-04

Locations

KR (1)