Quantitative Assessment of Orofacial Muscle Function in FSHD

Facioscapulohumeral Muscular Dystrophy Clinical Trial

Official title:

Development of a New Clinical Tool for the Assessment of Orofacial Muscles in Patients Affected by Facioscapulohumeral Muscular Dystrophy: a Preliminary Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06425445
• Other study ID #: P2024/031
• Status: Recruiting
• Phase: N/A
• Start date: May 14, 2024
• Est. completion date: September 30, 2024

Study information

• Verified date: May 2024
• Source: University of Mons
• Contact: Eliot Rudy Mbolo Ebubu (PhD candidate, MD, study investigator)
• Phone: 0032485114738
• Email: 535678[@]umons.ac.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this study is to validate a new method for the assessment of orofacial muscles in FSHD affected individuals, using maximal expiratory pressures (MEPs).

Our hypothesis is the following:

• The pressure drop observed when using circular mouthpieces (versus ovoid mouthpieces) is a reflection of orofacial dysfunction in FSHD affected individuals

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 65 Years

Eligibility

Inclusion Criteria:

• Genetic diagnosis of FSHD type 1 and/or type 2

Exclusion Criteria:

• Pregnant women

• Presence of other associated neuromuscular conditions

• Any unstable interfering clinical situation

Related Conditions & MeSH terms

• Facioscapulohumeral Muscular Dystrophy
• Muscular Dystrophies
• Muscular Dystrophy, Facioscapulohumeral

Intervention

Procedure:
• Measurement of maximal expiratory pressures during forced static expiratory maneuvers sustained over 5 seconds
Participants perform forced static expiratory maneuvers sustained over a five second period

Locations

Country	Name	City	State
Belgium	University of Mons	Mons	Hainaut

Sponsors (1)

Lead Sponsor	Collaborator
University of Mons

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The pressure drop	The pressure drop (PD) is defined as the pressure difference between a reference ovoid-shaped mouthpiece and variously-sized circular mouthpieces, divided by the reference pressure. It is a relative value that is expected to reflect the magnitude of orofacial muscle dysfunction in FSHD affected individuals.	The pressure drop will be assessed for each study participant at visit 1 and subsequently at visit 2 (3 months later). The measurements as such, should take about 30 minutes for each participant