Assessing Fatiguability of Tongue Muscles in MS

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03817073
• Other study ID #: TMALA19JVDW01
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: July 1, 2021

Study information

• Verified date: January 2019
• Source: Thomas More Kempen
• Contact: Jan Vanderwegen, MD
• Phone: 03 241 08 29
• Email: jan.vanderwegen[@]thomasmore.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: July 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• proven MS

• subjective dysphagia

Exclusion Criteria:

• MMSE < 23

• major head and neck surgery

• history of cancer

Related Conditions & MeSH terms

• Deglutition Disorders
• Exertion; Excess
• Fatigue
• Multiple Sclerosis
• Muscle Weakness
• Paresis
• Sclerosis

Intervention

Device:
• Iowa Oral Performance Instrument (IOPI)
Using biofeedback to attain repetitions of 80% of baseline MIP.

Locations

Country	Name	City	State
Belgium	Thomas More University College of Applied Sciences	Antwerp	Antwerpen

Sponsors (2)

Lead Sponsor	Collaborator
Thomas More Kempen	Revalidatie & MS Centrum Overpelt

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of successful repetitions	The number of repetitions where the target force was developed.	30 minutes
Primary	Evolution of MIP during subsequent repetitions	The change in MIP after each 5 repetitions.	30 minutes
Secondary	Baseline MIP as predictor for number of repetitions	Does baseline MIP predict the number of successful repetitions.	30 minutes