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Assessing Fatiguability of Tongue Muscles in MS

Primary Purpose

Muscle Weakness, Fatigue, Multiple Sclerosis

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Iowa Oral Performance Instrument (IOPI)
Sponsored by
Thomas More Kempen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Muscle Weakness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • proven MS
  • subjective dysphagia

Exclusion Criteria:

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

Sites / Locations

  • Thomas More University College of Applied Sciences

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Iowa Oral Performance Instrument (IOPI)

Arm Description

All MS patients will be included in this arm to compare with a historical control arm. Iowa Oral Performance Instrument (IOPI).

Outcomes

Primary Outcome Measures

Number of successful repetitions
The number of repetitions where the target force was developed.
Evolution of MIP during subsequent repetitions
The change in MIP after each 5 repetitions.

Secondary Outcome Measures

Baseline MIP as predictor for number of repetitions
Does baseline MIP predict the number of successful repetitions.

Full Information

First Posted
January 8, 2019
Last Updated
January 24, 2019
Sponsor
Thomas More Kempen
Collaborators
Revalidatie & MS Centrum Overpelt
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1. Study Identification

Unique Protocol Identification Number
NCT03817073
Brief Title
Assessing Fatiguability of Tongue Muscles in MS
Official Title
Assessing Fatiguability of Tongue Muscles and the Effect on Tongue Strength and Swallowing Pressures in Patients With Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2019 (Anticipated)
Primary Completion Date
July 1, 2021 (Anticipated)
Study Completion Date
July 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Thomas More Kempen
Collaborators
Revalidatie & MS Centrum Overpelt

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Weakness, Fatigue, Multiple Sclerosis, Deglutition Disorders, Exertion; Excess

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Iowa Oral Performance Instrument (IOPI)
Arm Type
Experimental
Arm Description
All MS patients will be included in this arm to compare with a historical control arm. Iowa Oral Performance Instrument (IOPI).
Intervention Type
Device
Intervention Name(s)
Iowa Oral Performance Instrument (IOPI)
Intervention Description
Using biofeedback to attain repetitions of 80% of baseline MIP.
Primary Outcome Measure Information:
Title
Number of successful repetitions
Description
The number of repetitions where the target force was developed.
Time Frame
30 minutes
Title
Evolution of MIP during subsequent repetitions
Description
The change in MIP after each 5 repetitions.
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Baseline MIP as predictor for number of repetitions
Description
Does baseline MIP predict the number of successful repetitions.
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: proven MS subjective dysphagia Exclusion Criteria: MMSE < 23 major head and neck surgery history of cancer
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jan Vanderwegen, MD
Phone
03 241 08 29
Email
jan.vanderwegen@thomasmore.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Vanderwegen
Organizational Affiliation
Thomas More University College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomas More University College of Applied Sciences
City
Antwerp
State/Province
Antwerpen
ZIP/Postal Code
2018
Country
Belgium
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JAN VANDERWEGEN, MD
Phone
+32 3 241 08 29
Email
jan.vanderwegen@thomasmore.be

12. IPD Sharing Statement

Plan to Share IPD
No

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Assessing Fatiguability of Tongue Muscles in MS

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