Assessing Fatiguability of Tongue Muscles in MS

Not Applicable

• Conditions: Deglutition Disorders; Multiple Sclerosis; Muscle Weakness; Fatigue; Exertion; Excess
• Interventions: Device: Iowa Oral Performance Instrument (IOPI)

• Registration Number: NCT03817073
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2019-01
• Study First Submitted: 2019-01-08
• Study First Submitted QC: 2019-01-24
• Last Update Submitted: 2019-01-24
• Study First Posted: 2019-01-25
• Last Update Posted: 2019-01-25
• Study Start: 2019-03-01
• Primary Completion: 2021-07-01
• Study Completion: 2021-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• proven MS
• subjective dysphagia

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Iowa Oral Performance Instrument (IOPI)	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).

Primary Outcome Measures

Name	Time	Method
Evolution of MIP during subsequent repetitions	30 minutes	The change in MIP after each 5 repetitions.
Number of successful repetitions	30 minutes	The number of repetitions where the target force was developed.

Secondary Outcome Measures

Name	Time	Method
Baseline MIP as predictor for number of repetitions	30 minutes	Does baseline MIP predict the number of successful repetitions.

Trial Locations

Locations (1)

Thomas More University College of Applied Sciences; 🇧🇪 Antwerp, Antwerpen, Belgium