Study Results
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View full resultsBasic Information
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COMPLETED
108 participants
OBSERVATIONAL
2017-11-20
2023-02-02
Brief Summary
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Funding Source- Food and Drug Administration Office of Orphan Products Development (FDA OOPD).
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Detailed Description
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A select number of Children's Hospital of Philadelphia (CHOP) participants will have the opportunity to participate in further procedures to better understand how FA affects different tissues. These include a Magnetic Resonance Imaging (MRI) scan and a Motor Evoked Potentials (MEP) procedure.
The MRI scan analyzes how muscle activity is affected in FA. The magnet will be used to capture images of the calf muscle before and after exercising on an ergonomic foot pedal.
The MEP procedure measures how strong the connection is between the brain's motor cortex and a selected body part, specifically the participant's dominant hand.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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FA Children
Children between the ages of 2 and 18 with genetically confirmed Friedreich's Ataxia
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Genetically confirmed diagnosis of Friedreich's Ataxia (FA) or clinically confirmed diagnosis of FA, pending confirmatory genetic testing through a commercial or research laboratory
3. Parental/guardian permission (informed consent) and if appropriate, child assent.
Exclusion Criteria
2 Years
18 Years
ALL
No
Sponsors
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University of Florida
OTHER
University of California, Los Angeles
OTHER
Food and Drug Administration (FDA)
FED
Friedreich's Ataxia Research Alliance
OTHER
Children's Hospital of Philadelphia
OTHER
Responsible Party
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Principal Investigators
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David Lynch, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
Locations
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University of California, Los Angeles
Los Angeles, California, United States
University of Florida
Gainesville, Florida, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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FD006029-01
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
17-014390
Identifier Type: -
Identifier Source: org_study_id
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