Status:
COMPLETED
Lingual Muscle Training in Late-Onset Pompe Disease (LOPD)
Lead Sponsor:
Duke University
Conditions:
Glycogen Storage Disease
Eligibility:
All Genders
12+ years
Phase:
NA
Brief Summary
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 futur...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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
- Exclusion Criteria:
- 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
Exclusion
Key Trial Info
Start Date :
March 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 23 2020
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03255213
Start Date
March 21 2018
End Date
April 23 2020
Last Update
July 28 2021
Active Locations (1)
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1
Duke University Medical Center and affiliated practices
Durham, North Carolina, United States, 27710