Assessing Fatiguability of Tongue Muscles in MS

January 24, 2019 updated by: Jan Vanderwegen, Thomas More Kempen

Assessing Fatiguability of Tongue Muscles and the Effect on Tongue Strength and Swallowing Pressures in Patients With Multiple Sclerosis

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Antwerpen
      • Antwerp, Antwerpen, Belgium, 2018
        • Thomas More University College of Applied Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • proven MS
  • subjective dysphagia

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of successful repetitions
Time Frame: 30 minutes
The number of repetitions where the target force was developed.
30 minutes
Evolution of MIP during subsequent repetitions
Time Frame: 30 minutes
The change in MIP after each 5 repetitions.
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Baseline MIP as predictor for number of repetitions
Time Frame: 30 minutes
Does baseline MIP predict the number of successful repetitions.
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thomas More Kempen

Collaborators

Revalidatie & MS Centrum Overpelt

Investigators

  • Principal Investigator: Jan Vanderwegen, Thomas More University College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2019

Primary Completion (Anticipated)

July 1, 2021

Study Completion (Anticipated)

July 1, 2021

Study Registration Dates

First Submitted

January 8, 2019

First Submitted That Met QC Criteria

January 24, 2019

First Posted (Actual)

January 25, 2019

Study Record Updates

Last Update Posted (Actual)

January 25, 2019

Last Update Submitted That Met QC Criteria

January 24, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TMALA19JVDW01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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