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Assessing Fatiguability of Tongue Muscles in MS

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03817073
Enrollment
60
Registered
2019-01-25
Start date
2019-03-01
Completion date
2021-07-01
Last updated
2019-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muscle Weakness, Fatigue, Multiple Sclerosis, Deglutition Disorders, Exertion; Excess

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.

Interventions

Using biofeedback to attain repetitions of 80% of baseline MIP.

Sponsors

Revalidatie & MS Centrum Overpelt
CollaboratorOTHER
Thomas More Kempen
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* proven MS * subjective dysphagia

Exclusion criteria

* MMSE \< 23 * major head and neck surgery * history of cancer

Design outcomes

Primary

MeasureTime frameDescription
Number of successful repetitions30 minutesThe number of repetitions where the target force was developed.
Evolution of MIP during subsequent repetitions30 minutesThe change in MIP after each 5 repetitions.

Secondary

MeasureTime frameDescription
Baseline MIP as predictor for number of repetitions30 minutesDoes baseline MIP predict the number of successful repetitions.

Countries

Belgium

Contacts

Primary ContactJan Vanderwegen, MD
jan.vanderwegen@thomasmore.be03 241 08 29

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026