Lingual Muscle Training in Late-Onset Pompe Disease (LOPD)

Completed · Not applicable

Conditions studied: Glycogen Storage Disease

In brief

This study is being done to test the effects of Lingual Muscle Therapy (LMT) in patients with Late-Onset Pompe Disease (LOPD) who have tongue weakness. The results of this study will help design future research studies about LMT in LOPD.

Key facts

Study ID

NCT03255213

Run by

Duke University

People needed

5

Starts

2018-03-21

Expected to finish

2020-04-23

Last updated by the study team

2021-07-28

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 12 years
• Lingual weakness as measured by quantitative muscle testing (≤ 5% lower limit of normal for stratified age)
• Confirmed diagnosis of LOPD
• On enzyme replacement therapy for ≥ 26 weeks at pretest
• Able to follow directions for study participation
• Able to complete a home-based LMT regimen
• Access to reliable internet connection
• Access to use of electronic device that allows for FaceTime, Jabber, or WebEx use

You may not qualify if…

• Neurodegenerative conditions (e.g. stroke, dementia) or other serious neurologic condition that would prevent meaningful study participation as determined at the discretion of the principle investigator
• Any current or past history of seizures.
• Head and neck cancer or radiation treatment to head/neck
• Inability to tolerate IOPI device tongue bulb
• Inability to give legally effective consent
• Inability to read and understand English

Where it is running

• Duke University Medical Center and affiliated practices — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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