Assessing Fatiguability of Tongue Muscles in MS

Thomas More Kempen

Status: Unknown

Conditions: Multiple Sclerosis; Muscle Weakness; Exertion; Excess; Deglutition Disorders; Fatigue

Treatments: Device: Iowa Oral Performance Instrument (IOPI)

Study type: Interventional

Funder types: Other

Identifiers

NCT03817073

TMALA19JVDW01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• proven MS
• subjective dysphagia

Exclusion criteria

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Iowa Oral Performance Instrument (IOPI)

Experimental group

Description:

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

Treatment:

Device: Iowa Oral Performance Instrument (IOPI)