A Natural History Study to TRACK Brain and Spinal Cord Changes in Individuals with Friedreich Ataxia (TRACK-FA)

Running, not enrolling

Conditions studied: Friedreich Ataxia

In brief

This is a natural history study prospectively investigating neuroimaging markers of disease progression in children and adults with Friedreich ataxia (FA). There will be three assessment periods (baseline, 12 and 24 months). The study will include approximately 200 individuals with FA and 100 matched controls recruited across the six international academic sites. Other assessments will include secondary clinical and cognitive markers, as well as exploratory blood markers.

Key facts

Study ID

NCT04349514

Run by

Monash University

People needed

300

Starts

2021-02-10

Expected to finish

2025-10-01

Last updated by the study team

2024-11-27

Who can join

Age: 5 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age ≥ 5 years
• Written informed consent provided
• Individuals with FA must have a genetic confirmation of diagnosis and be biallelic for a GAA repeat length > 55 in intron 1 of FXN and/or have a GAA repeat length > 55 in intron 1 of FXN in one allele and another type of mutation that is inferred to cause loss of function in the second FXN allele
• Individuals with FA must have an age of disease onset ≤ 25 years
• Individuals with FA must have a disease duration ≤ 25 years
• Individuals with FA must have a Friedreich Ataxia Rating Scale (FARS) Functional staging score of ≤ 5 and total modified FARS (mFARS) score of ≤ 65 on enrolment

You may not qualify if…

• Age < 5 years
• Unable to provide written informed consent
• Magnetic resonance contraindications (e.g. pacemaker or other metallic surgical implants)
• Presence of metallic dental braces
• Pregnancy (ascertained via a question or test as mandated at particular sites)
• Individuals with FA must not have acute or ongoing medical or other conditions that, after discussion between the Site Investigator and steering committee, is deemed to interfere with the conduct and assessments of the study
• Individuals with FA must not have another neurological condition apart from FA
• Individuals with FA must not have other neurologic conditions that, in the opinion of the Site Investigator, would interfere with the conduct and assessments of the study
• Controls must not have a diagnosed psychiatric or neurological condition
• Controls must not have acute or ongoing medical or other conditions that would interfere with the conduct and assessments of the study
• Controls must not be siblings of individuals with FA whose carrier status (i.e., confirmed carrier, confirmed non-carrier, or obligate carrier) is unknown.

Where it is running

• University of Florida — Gainesville, Florida, United States
• Center for Magnetic Resonance Research, University of Minnesota — Minneapolis, Minnesota, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Monash Biomedical Imaging, Monash University — Clayton, Victoria, Australia
• Lab of Neuroimaging and Dept of Neurology, University of Campinas (UNICAMP) — São Paulo, São Paulo, Brazil
• McGill University — Montreal, Quebec, Canada
• Department of Neurology, RWTH Aachen University — Aachen, Germany

Full record on ClinicalTrials.gov

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