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Assessing Fatiguability of Tongue Muscles in MS

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ClinicalTrials.gov Identifier: NCT03817073
Recruitment Status : Not yet recruiting
First Posted : January 25, 2019
Last Update Posted : January 25, 2019
Sponsor:
Collaborator:
Revalidatie & MS Centrum Overpelt
Information provided by (Responsible Party):
Jan Vanderwegen, Thomas More Kempen

Brief Summary:
Multiple Sclerosis (MS) patients with subjective dysphagia will be tested for tongue strength fatigue using a strictly defined fatigue paradigm. A maximum of 40 sets will be performed, each set consisting of 5 repetitions of 80% of maximum isometric pressure (MIP) at the anterior tongue, followed by a MIP at the anterior tongue. Cut-off criteria are a MIP <50% of the baseline MIP, pronounced subjective discomfort and/or exceeding the allocated test time of 30 minutes.

Condition or disease Intervention/treatment Phase
Muscle Weakness Fatigue Multiple Sclerosis Deglutition Disorders Exertion; Excess Device: Iowa Oral Performance Instrument (IOPI) Not Applicable

Detailed Description:
Eligibility is Mini-Mental State Exam-score (MMSE) > 23, a Eating Assessment Tool-score (EAT-10) > 3, or a Functional Oral Intake Scale-score (FOIS) < 7, or failing the Yale Swallow Protocol.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Assessing Fatiguability of Tongue Muscles and the Effect on Tongue Strength and Swallowing Pressures in Patients With Multiple Sclerosis
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Iowa Oral Performance Instrument (IOPI)
All MS patients will be included in this arm to compare with a historical control arm. Iowa Oral Performance Instrument (IOPI).
Device: Iowa Oral Performance Instrument (IOPI)
Using biofeedback to attain repetitions of 80% of baseline MIP.




Primary Outcome Measures :
  1. Number of successful repetitions [ Time Frame: 30 minutes ]
    The number of repetitions where the target force was developed.

  2. Evolution of MIP during subsequent repetitions [ Time Frame: 30 minutes ]
    The change in MIP after each 5 repetitions.


Secondary Outcome Measures :
  1. Baseline MIP as predictor for number of repetitions [ Time Frame: 30 minutes ]
    Does baseline MIP predict the number of successful repetitions.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • proven MS
  • subjective dysphagia

Exclusion Criteria:

  • MMSE < 23
  • major head and neck surgery
  • history of cancer

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): NCT03817073


Contacts
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Contact: Jan Vanderwegen, MD 03 241 08 29 jan.vanderwegen@thomasmore.be

Locations
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Belgium
Thomas More University College of Applied Sciences
Antwerp, Antwerpen, Belgium, 2018
Contact: JAN VANDERWEGEN, MD    +32 3 241 08 29    jan.vanderwegen@thomasmore.be   
Sponsors and Collaborators
Thomas More Kempen
Revalidatie & MS Centrum Overpelt
Investigators
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Principal Investigator: Jan Vanderwegen Thomas More University College
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Responsible Party: Jan Vanderwegen, Principal Investigator, Clinical Professor, Thomas More Kempen
ClinicalTrials.gov Identifier: NCT03817073    
Other Study ID Numbers: TMALA19JVDW01
First Posted: January 25, 2019    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Muscle Weakness
Deglutition Disorders
Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases