Ignite Creation Date:
2024-05-06 @ 12:38 PM
Last Modification Date:
2024-10-26 @ 1:02 PM
Study NCT ID:
NCT03817073
Status:
UNKNOWN
Last Update Posted:
2019-01-25
First Post:
2019-01-08
Brief Title:
Assessing Fatiguability of Tongue Muscles in MS
Sponsor:
Thomas More Kempen
Organization:
Thomas More Kempen
Study Overview
Official Title:
Assessing Fatiguability of Tongue Muscles and the Effect on Tongue Strength and Swallowing Pressures in Patients With Multiple Sclerosis
Status:
UNKNOWN
Status Verified Date:
2019-01
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None