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Completed

NCT Number: NCT03255213

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

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.

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Key information

Conditions

Glycogen Storage Disease Carbohydrate Metabolism, Inborn Errors Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center and affiliated practices

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lingual Muscle Training

Other

Lingual Muscle Training using the Iowa Oral Performance Instrument (OIPI) device

Primary outcomes

  1. Safety of lingual muscle training

    Time frame: 13 weeks

    Safety measured by pain rating scale

  2. Feasibility of lingual muscle training as measured by questionnaires

    Time frame: 13 weeks

Secondary outcomes

  1. Change in lingual strength

    Time frame: baseline, 13 weeks

    Change from pre-test to post-test

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 21, 2017
Registry last updated
Jul 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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