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Assess the Safety and Efficacy of the 4 Channel NMES, Pilot Study

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ClinicalTrials.gov Identifier: NCT03664479
Recruitment Status : Terminated (collected data showed significant difference in two groups.)
First Posted : September 10, 2018
Last Update Posted : September 14, 2018
Sponsor:
Information provided by (Responsible Party):
Ju Seok Ryu, Seoul National University Hospital

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
Dysphagia Device: 4 channel Electrical Stimulation Device Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 1, 2018
Actual Primary Completion Date : June 1, 2018
Actual Study Completion Date : June 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Device: 4 channel Electrical Stimulation Device
electrical stimulation at muscles which related with deglutition

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.
Device: 4 channel Electrical Stimulation Device
electrical stimulation at muscles which related with deglutition




Primary Outcome Measures :
  1. 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.) ]
  2. 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



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03664479


Locations
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Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Gyeonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Study Director: Jusuk Ryu, M.D. PhD Seoul National University Bundang Hospital

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Responsible Party: Ju Seok Ryu, associate professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03664479     History of Changes
Other Study ID Numbers: E-1706/402-001
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ju Seok Ryu, Seoul National University Hospital:
stroke
cervical spinal cord injury

Additional relevant MeSH terms:
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Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases