Muscle WeaknessNCT03817073
Assessing Fatiguability of Tongue Muscles in MS
A study testing Iowa Oral Performance Instrument (IOPI) in people with Muscle Weakness and Fatigue, run by Thomas More Kempen at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle Weakness, Fatigue, Multiple Sclerosis
- What is being tested?
- Iowa Oral Performance Instrument (IOPI)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Mar 2019to 1 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- proven MS
- subjective dysphagia
Who cannot join
- MMSE < 23
- major head and neck surgery
- history of cancer
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Thomas More University College of Applied Sciences
Antwerp, Antwerpen, 2018
JAN VANDERWEGEN, MD, +32 3 241 08 29, jan.vanderwegen@thomasmore.be
About this study
Official title: Assessing Fatiguability of Tongue Muscles and the Effect on Tongue Strength and Swallowing Pressures in Patients With Multiple Sclerosis
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.
Read the 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.
- Being tested
- Iowa Oral Performance Instrument (IOPI)
- Medical subject headings
- Muscle Weakness, Fatigue, Multiple Sclerosis, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iowa Oral Performance Instrument (IOPI)Device
Using biofeedback to attain repetitions of 80% of baseline MIP.
| Study group | Role | What they receive |
|---|---|---|
| Iowa Oral Performance Instrument (IOPI) | Experimental | All MS patients will be included in this arm to compare with a historical control arm. Iowa Oral Performance Instrument (IOPI). Receives: Device: Iowa Oral Performance Instrument (IOPI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of successful repetitions
The number of repetitions where the target force was developed.
Measured: 30 minutes
Evolution of MIP during subsequent repetitions
The change in MIP after each 5 repetitions.
Measured: 30 minutes
Secondary outcomes (1)
Baseline MIP as predictor for number of repetitions
Does baseline MIP predict the number of successful repetitions.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start1 Mar 2019 (estimated)
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle WeaknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas More Kempen
- Sponsor type
- University, hospital or other
- Collaborators
- Revalidatie & MS Centrum Overpelt
- Responsible party
- Principal investigator, Jan Vanderwegen, Thomas More Kempen
- Investigators
- Jan Vanderwegen, Principal investigator, Thomas More University College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03817073
- Sponsor's protocol ID
- TMALA19JVDW01
- Status last verified
- Jan 2019
- First submitted
- 8 Jan 2019
- Last updated
- 25 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Fatiguability of Tongue Muscles and the Effect on Tongue Strength and Swallowing Pressures in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03817073
- Acronym / sponsor ID
- TMALA19JVDW01
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Thomas More KempenUniversity, hospital or other
- Collaborators
- Revalidatie & MS Centrum Overpelt
- Study start
- 1 Mar 2019 (estimated)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 25 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iowa Oral Performance Instrument (IOPI) | Experimental | Device: 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- proven MS
- subjective dysphagia
Key exclusion criteria (3 listed)
- MMSE < 23
- major head and neck surgery
- history of cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iowa Oral Performance Instrument (IOPI)Using biofeedback to attain repetitions of 80% of baseline MIP. | Device | Iowa Oral Performance Instrument (IOPI) |
Primary outcome
Number of successful repetitions
Time frame: 30 minutes
The number of repetitions where the target force was developed.
Evolution of MIP during subsequent repetitions
Time frame: 30 minutes
The change in MIP after each 5 repetitions.
1 secondary outcome
Baseline MIP as predictor for number of repetitions
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Vanderwegen principal investigator
Thomas More University College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iowa Oral Performance Instrument (IOPI) in people with Muscle Weakness and Fatigue, run by Thomas More Kempen at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jan Vanderwegen, MD (03 241 08 29, jan.vanderwegen@thomasmore.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of successful repetitions (time frame: 30 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2019.