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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04349514
Registration number
NCT04349514
Ethics application status
Date submitted
1/04/2020
Date registered
16/04/2020
Titles & IDs
Public title
A Natural History Study to TRACK Brain and Spinal Cord Changes in Individuals With Friedreich Ataxia (TRACK-FA)
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Scientific title
A Natural History Study to TRACK Brain and Spinal Cord Changes in Individuals With Friedreich Ataxia (TRACK-FA)
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Secondary ID [1]
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TRACK-FA
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Universal Trial Number (UTN)
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Trial acronym
(TRACK-FA)
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Friedreich Ataxia
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Condition category
Condition code
Neurological
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Other neurological disorders
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Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Neurological
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Neurodegenerative diseases
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Other interventions - Natural history
Friedreich ataxia - Individuals with a diagnosis of Friedreich ataxia.
Control - Individuals without a diagnosis of Friedreich ataxia.
Other interventions: Natural history
Longitudinal observation of neuroimaging, clinical, and blood markers.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Baseline dentate nuclei magnetic susceptibility
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Assessment method [1]
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Magnetic susceptibility of the dentate nuclei will be measured using T2\*-weighted multiecho magnetic resonance imaging and quantitative susceptibility mapping processing. Baseline dentate nuclei susceptibility will be compared between the Friedreich ataxia and control groups. This measurement will be obtained for participants aged 11 years and over.
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Timepoint [1]
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Baseline
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Primary outcome [2]
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Slope of change in dentate nuclei magnetic susceptibility
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Assessment method [2]
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Magnetic susceptibility of the dentate nuclei will be measured using T2\*-weighted multiecho magnetic resonance imaging and quantitative susceptibility mapping processing. The within-person slope of dentate nuclei susceptibility over the three study visits will be estimated and compared between the Friedreich ataxia and control groups. This measurement will be obtained for participants aged 11 years and over.
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Timepoint [2]
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Baseline to 24 months
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Primary outcome [3]
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Baseline dentate volume
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Assessment method [3]
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Volume of the dentate nuclei will be measured using T2\*-weighted multiecho magnetic resonance imaging and quantitative susceptibility mapping processing. Baseline dentate nuclei volume will be compared between the Friedreich ataxia and control groups. This measurement will be obtained for participants aged 11 years and over.
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Timepoint [3]
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Baseline
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Primary outcome [4]
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Slope of change in dentate volume
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Assessment method [4]
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Volume of the dentate nuclei will be measured using T2\*-weighted multiecho magnetic resonance imaging and quantitative susceptibility mapping processing. The within-person slope of dentate nuclei volume over the three study visits will be estimated and compared between the Friedreich ataxia and control groups. This measurement will be obtained for participants aged 11 years and over.
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Timepoint [4]
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Baseline to 24 months
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Primary outcome [5]
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Baseline total cerebellar volume
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Assessment method [5]
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Total volume of the cerebellum will be measured using T1- and T2-weighted magnetic resonance imaging. Baseline total cerebellar volume will be compared between the Friedreich ataxia and control groups.
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Timepoint [5]
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Baseline
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Primary outcome [6]
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Slope of change in total cerebellar volume
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Assessment method [6]
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Total volume of the cerebellum will be measured using T1- and T2-weighted magnetic resonance imaging. The within-person slope of total cerebellar volume over the three study visits will be estimated and compared between the Friedreich ataxia and control groups.
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Timepoint [6]
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Baseline to 24 months
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Primary outcome [7]
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Baseline superior cerebellar peduncle volume
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Assessment method [7]
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Volume of the superior cerebellar peduncles will be measured using T1- and T2-weighted magnetic resonance imaging. Baseline superior cerebellar peduncle volume will be compared between the Friedreich ataxia and control groups.
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Timepoint [7]
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Baseline
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Primary outcome [8]
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Slope of change in superior cerebellar peduncle volume
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Assessment method [8]
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Volume of the superior cerebellar peduncles will be measured using T1- and T2-weighted magnetic resonance imaging. The within-person slope of superior cerebellar peduncle volume over the three study visits will be estimated and compared between the Friedreich ataxia and control groups.
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Timepoint [8]
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Baseline to 24 months
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Primary outcome [9]
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Baseline superior cerebellar peduncle fractional anisotropy
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Assessment method [9]
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Fractional anisotropy of the superior cerebellar peduncles will be measured using diffusion tensor magnetic resonance imaging. Baseline superior cerebellar peduncle fractional anisotropy will be compared between the Friedreich ataxia and control groups. This measurement will be obtained for participants aged 11 years and over.
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Timepoint [9]
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Baseline
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Primary outcome [10]
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Slope of change in superior cerebellar peduncle fractional anisotropy
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Assessment method [10]
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Fractional anisotropy of the superior cerebellar peduncles will be measured using diffusion tensor magnetic resonance imaging. The within-person slope of superior cerebellar peduncle fractional anisotropy over the three study visits will be estimated and compared between the Friedreich ataxia and control groups. This measurement will be obtained for participants aged 11 years and over.
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Timepoint [10]
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Baseline to 24 months
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Primary outcome [11]
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Baseline superior cerebellar peduncle mean diffusivity
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Assessment method [11]
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Mean diffusivity of the superior cerebellar peduncles will be measured using diffusion tensor magnetic resonance imaging. Baseline superior cerebellar peduncle mean diffusivity will be compared between the Friedreich ataxia and control groups. This measurement will be obtained for participants aged 11 years and over.
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Timepoint [11]
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Baseline
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Primary outcome [12]
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Slope of change in superior cerebellar peduncle mean diffusivity
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Assessment method [12]
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Mean diffusivity of the superior cerebellar peduncles will be measured using diffusion tensor magnetic resonance imaging. The within-person slope of superior cerebellar peduncle mean diffusivity over the three study visits will be estimated and compared between the Friedreich ataxia and control groups. This measurement will be obtained for participants aged 11 years and over.
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Timepoint [12]
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Baseline to 24 months
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Primary outcome [13]
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Baseline superior cerebellar peduncle radial diffusivity
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Assessment method [13]
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Radial diffusivity of the superior cerebellar peduncles will be measured using diffusion tensor magnetic resonance imaging. Baseline superior cerebellar peduncle radial diffusivity will be compared between the Friedreich ataxia and control groups. This measurement will be obtained for participants aged 11 years and over.
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Timepoint [13]
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Baseline
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Primary outcome [14]
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Slope of change in superior cerebellar peduncle radial diffusivity
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Assessment method [14]
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Radial diffusivity of the superior cerebellar peduncles will be measured using diffusion tensor magnetic resonance imaging. The within-person slope of superior cerebellar peduncle radial diffusivity over the three study visits will be estimated and compared between the Friedreich ataxia and control groups. This measurement will be obtained for participants aged 11 years and over.
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Timepoint [14]
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Baseline to 24 months
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Primary outcome [15]
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Baseline superior cerebellar peduncle axial diffusivity
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Assessment method [15]
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Axial diffusivity of the superior cerebellar peduncles will be measured using diffusion tensor magnetic resonance imaging. Baseline superior cerebellar peduncle axial diffusivity will be compared between the Friedreich ataxia and control groups. This measurement will be obtained for participants aged 11 years and over.
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Timepoint [15]
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Baseline
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Primary outcome [16]
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Slope of change in superior cerebellar peduncle axial diffusivity
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Assessment method [16]
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Axial diffusivity of the superior cerebellar peduncles will be measured using diffusion tensor magnetic resonance imaging. The within-person slope of superior cerebellar peduncle axial diffusivity over the three study visits will be estimated and compared between the Friedreich ataxia and control groups. This measurement will be obtained for participants aged 11 years and over.
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Timepoint [16]
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Baseline to 24 months
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Primary outcome [17]
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Baseline cervical spinal cord cross-sectional area
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Assessment method [17]
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Cross-sectional area of the cervical portion of the spinal cord will be measured using T2-weighted magnetic resonance imaging. Baseline cervical spinal cord cross-sectional area will be compared between the Friedreich ataxia and control groups.
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Timepoint [17]
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Baseline
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Primary outcome [18]
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Slope of change in cervical spinal cord cross-sectional area
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Assessment method [18]
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Cross-sectional area of the cervical portion of the spinal cord will be measured using T2-weighted magnetic resonance imaging. The within-person slope of cervical spinal cord cross-sectional area over the three study visits will be estimated and compared between the Friedreich ataxia and control groups.
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Timepoint [18]
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Baseline to 24 months
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Primary outcome [19]
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Baseline cervical spinal cord fractional anisotropy
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Assessment method [19]
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Fractional anisotropy of the cervical portion of the spinal cord will be measured using diffusion tensor magnetic resonance imaging. Baseline cervical spinal cord fractional anisotropy will be compared between the Friedreich ataxia and control groups. This measurement will be obtained for participants aged 11 years and over.
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Timepoint [19]
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Baseline
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Primary outcome [20]
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Slope of change in cervical spinal cord fractional anisotropy
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Assessment method [20]
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Fractional anisotropy of the cervical portion of the spinal cord will be measured using diffusion tensor magnetic resonance imaging. The within-person slope of cervical spinal cord fractional anisotropy over the three study visits will be estimated and compared between the Friedreich ataxia and control groups. This measurement will be obtained for participants aged 11 years and over.
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Timepoint [20]
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Baseline to 24 months
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Primary outcome [21]
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Baseline cervical spinal cord mean diffusivity
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Assessment method [21]
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Mean diffusivity of the cervical portion of the spinal cord will be measured using diffusion tensor magnetic resonance imaging. Baseline cervical spinal cord mean diffusivity will be compared between the Friedreich ataxia and control groups. This measurement will be obtained for participants aged 11 years and over.
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Timepoint [21]
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Baseline
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Primary outcome [22]
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Slope of change in cervical spinal cord mean diffusivity
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Assessment method [22]
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Mean diffusivity of the cervical portion of the spinal cord will be measured using diffusion tensor magnetic resonance imaging. The within-person slope of cervical spinal cord mean diffusivity over the three study visits will be estimated and compared between the Friedreich ataxia and control groups. This measurement will be obtained for participants aged 11 years and over.
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Timepoint [22]
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Baseline to 24 months
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Primary outcome [23]
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Baseline cervical spinal cord radial diffusivity
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Assessment method [23]
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Radial diffusivity of the cervical portion of the spinal cord will be measured using diffusion tensor magnetic resonance imaging. Baseline cervical spinal cord radial diffusivity will be compared between the Friedreich ataxia and control groups. This measurement will be obtained for participants aged 11 years and over.
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Timepoint [23]
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0
Baseline
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Primary outcome [24]
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Slope of change in cervical spinal cord radial diffusivity
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Assessment method [24]
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Radial diffusivity of the cervical portion of the spinal cord will be measured using diffusion tensor magnetic resonance imaging. The within-person slope of cervical spinal cord radial diffusivity over the three study visits will be estimated and compared between the Friedreich ataxia and control groups. This measurement will be obtained for participants aged 11 years and over.
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Timepoint [24]
0
0
Baseline to 24 months
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Primary outcome [25]
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Baseline cervical spinal cord axial diffusivity
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Assessment method [25]
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Axial diffusivity of the cervical portion of the spinal cord will be measured using diffusion tensor magnetic resonance imaging. Baseline cervical spinal cord axial diffusivity will be compared between the Friedreich ataxia and control groups. This measurement will be obtained for participants aged 11 years and over.
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Timepoint [25]
0
0
Baseline
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Primary outcome [26]
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Slope of change in cervical spinal cord axial diffusivity
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Assessment method [26]
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Axial diffusivity of the cervical portion of the spinal cord will be measured using diffusion tensor magnetic resonance imaging. The within-person slope of cervical spinal cord axial diffusivity over the three study visits will be estimated and compared between the Friedreich ataxia and control groups. This measurement will be obtained for participants aged 11 years and over.
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Timepoint [26]
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Baseline to 24 months
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Primary outcome [27]
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Baseline cervical spine tNAA/mIns ratio
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Assessment method [27]
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The ratio of N-acetylaspartate (tNAA) and myo-inositol (mIns) within cervical spinal cord will be measured using sLASER magnetic resonance spectroscopy. The baseline tNAA/mIns ratio will be compared between the Friedreich ataxia and control groups. This measurement will be obtained for participants aged 11 years and over.
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Timepoint [27]
0
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Baseline
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Primary outcome [28]
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Slope of the cervical spine tNAA/mIns ratio
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Assessment method [28]
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The ratio of N-acetylaspartate (tNAA) and myo-inositol (mIns) within cervical spinal cord will be measured using sLASER magnetic resonance spectroscopy. The within-person slope of the tNAA/mIns ratio over the three study visits will be estimated and compared between the Friedreich ataxia and control groups. This measurement will be obtained for participants aged 11 years and over.
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Timepoint [28]
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Baseline to 24 months
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Secondary outcome [1]
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Modified Friedreich Ataxia Rating Scale (mFARS) score
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Assessment method [1]
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The modified Friedreich Ataxia Rating Scale (mFARS) is a neurological rating scale comprising four subscales (bulbar, upper limb coordination, lower limb coordination, and upright stability). The total score ranges from 0 to 93, with a higher score reflecting greater neurological severity. This assessment will be administered to participants with FA only.
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Timepoint [1]
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Baseline to 24 months
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Secondary outcome [2]
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Upright Stability (US) score
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Assessment method [2]
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The Upright Stability (US) assessment is part of the neurological examination within the Modified Friedreich Ataxia Rating Scale (mFARS). This component comprises nine items: sitting position, stance with feet apart, stance with feet apart and eyes closed, stance with feet together, stance with feet together and eyes closed, tandem stance, stance with dominant foot, tandem walk, and gait. The score ranges from 0 to 9, with a higher score reflecting poorer upright stability (i.e., greater neurological severity). This assessment will be administered to participants with FA only.
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Timepoint [2]
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Baseline to 24 months
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Secondary outcome [3]
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Activities of Daily Living (ADL) score
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Assessment method [3]
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Activities of Daily Living (ADL) is a component of the Friedreich Ataxia Rating Scale (FARS), a clinical rating scale developed for FA. The ADL score aims to quantify essential and routine aspects of self-care, often reported on by a family member or caregiver of a person with FA. The ADL comprises 9 items: speech, swallowing, cutting food and handling utensils, dressing, personal hygiene, falling, walking, quality of sitting position, and bladder function. The score ranges from 0 to 36, with a higher score reflecting greater difficulty completing activities of daily living independently. This assessment will be administered to participants with FA only.
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Timepoint [3]
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Baseline to 24 months
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Secondary outcome [4]
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Scale for the Assessment and Rating of Ataxia (SARA) score
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Assessment method [4]
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The SARA is a semi-quantitative assessment of ataxia, measuring ataxia of upper limb, lower limb, gait, balance and speech. It has eight items: gait, stance, sitting, speech disturbance, finger chase, nose-finger test, fast alternating hand movement, and heel-shin slide. The total score ranges from 0 (no ataxia) to 40 (severe ataxia). This assessment will be administered to participants with FA only.
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Timepoint [4]
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Baseline to 24 months
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Secondary outcome [5]
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9 Hole Peg Test times
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Assessment method [5]
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The 9 Hole Peg Test (9HPT) examines finger dexterity and involves placing and removing nine pegs in a pegboard in the quickest possible time. Two consecutive trials of the dominant hand, followed immediately by two consecutive trials of the non-dominant hand, are undertaken. The average time taken to complete the task, for each of the dominant and non-dominant hand, is calculated. The 9HPT has high intra- and inter-rater reliability and is the most commonly used measure of upper limb function in FA. This assessment will be administered to participants with FA only.
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Timepoint [5]
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0
Baseline to 24 months
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Secondary outcome [6]
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Speech analysis scores
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Assessment method [6]
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A battery of speech evaluations will be administered and recorded on a laptop for analysis, using Redenlab software. This will include: reading of a phonetically-balanced passage, sustained vowel sound, listing days of the week, repeating syllables, and a monologue task. This will form a measure of dysarthria. Redenlab is a US-Australian speech-testing company, https://redenlab.com. This assessment will be administered to participants with FA and controls.
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Timepoint [6]
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Baseline to 24 months
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Secondary outcome [7]
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Low-Contrast Sloan Letter Chart (LCSLC) test score
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Assessment method [7]
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Contrast letter acuity for vision will be assessed using back-lit Low-Contrast Sloan Letter Charts (LCSLCs). Participants will sit at an eye distance of 2 metres from the chart. Binocular vision will be assessed using participants' normal corrective lenses where relevant. Participants are required to read each letter on the chart. Three charts will be presented, with three different visual contrast levels: 100% (equivalent to high-contrast visual acuity), 2.5%, and 1.25%. The maximum total score across the three charts (number of letters read correctly) is 240. Scores for each individual chart will also be recorded. This assessment will be administered to participants with FA only.
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Timepoint [7]
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0
Baseline to 24 months
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Secondary outcome [8]
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Cerebellar Cognitive Affective/Schmahmann Syndrome (CCAS) scale score
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Assessment method [8]
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The Cerebellar Cognitive Affective/Schmahmann Syndrome (CCAS) Scale is a 10-item screening measure assessing attention and concentration, executive functioning, memory, language, visuospatial functioning, abstract thinking, and neuropsychiatric features. Each item has an associated raw score and pass/fail evaluation. The total raw score (maximum 120) and the total number of "failed" items (maximum 10) will be recorded. This scale is to be administered to participants who are aged 18 years and over. This assessment will be administered to participants with FA and controls.
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Timepoint [8]
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Baseline to 24 months
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Secondary outcome [9]
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Hayling Sentence Completion Test (HSCT) scores
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Assessment method [9]
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The Hayling Sentence Completion Test (HSCT) is an orally-administered test measuring response initiation and response suppression. In the first section, participants are asked to complete a series of incomplete sentences with a sensible word. In the second section, participants are asked to supply an unrelated word to complete each sentence. Scaled scores for total response latency in each section, a scaled score for errors in the second section, and an overall scale score are calculated. This test is to be administered to participants who are aged 18 years and over. This assessment will be administered to participants with FA and controls.
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Timepoint [9]
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0
Baseline to 24 months
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Secondary outcome [10]
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0
Hospital Anxiety and Depression Scale (HADS) scores
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Assessment method [10]
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The Hospital Anxiety and Depression Scale (HADS) is a 14-item self-assessment scale designed to screen for states of depression and anxiety and measure the severity of these states. It contains a 7-item subscale for each of Anxiety (HADS-A) and Depression (HADS-D). Possible scores for each of the HADS-Anxiety and HADS-Depression scales range from 0 to 21. Higher scores indicate more severe anxiety and depression. This scale is be administered to participants who are aged 18 year and over. This assessment will be administered to participants with FA and controls.
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Timepoint [10]
0
0
Baseline to 24 months
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Secondary outcome [11]
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Junior Hayling Sentence Completion Test (Junior HSCT) scores
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Assessment method [11]
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The Junior Hayling Sentence Completion Test (Junior HSCT) is an orally-administered measure of response initiation and response suppression in children. To be administered to participants who are aged at least 8 years but less than 18 years. This assessment will be administered to participants with FA and controls.
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Timepoint [11]
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0
Baseline to 24 months
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Secondary outcome [12]
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0
Paediatric Cerebellar Cognitive Affective/Schmahmann Syndrome (CCAS) scale score
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Assessment method [12]
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0
The Paediatric Cerebellar Cognitive Affective/Schmahmann Syndrome (CCAS) scale is an assessment of the executive, visual-spatial and linguistic components of cognitive control and affect in children. Currently under development. To be incorporated as a secondary outcome measure if available at the time of study commencement. To be administered to participants who are aged at least 8 years but less than 18 years. This assessment will be administered to participants with FA and controls.
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Timepoint [12]
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0
Baseline to 24 months
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Secondary outcome [13]
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0
Revised Children's Anxiety and Depression scale (RCADS) scores
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Assessment method [13]
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0
The Revised Child Anxiety and Depression Scale (RCADS) is a 47-item, self-report questionnaire six subscales: separation anxiety disorder, social phobia, generalized anxiety disorder, panic disorder, obsessive compulsive disorder, and major depressive disorder. It also yields a Total Anxiety Scale and a Total Internalizing Scale. A higher score indicates a higher level of the given disorder/syndrome. This scale is to be administered to participants who are aged at least 8 years but less than 18 years. This assessment will be administered to participants with FA and controls.
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Timepoint [13]
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0
Baseline to 24 months
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Eligibility
Key inclusion criteria
* 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
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Minimum age
5
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* 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.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
10/02/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/08/2025
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Actual
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Sample size
Target
300
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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0
Monash Biomedical Imaging, Monash University - Clayton
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Recruitment postcode(s) [1]
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3168 - Clayton
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Recruitment outside Australia
Country [1]
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0
United States of America
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State/province [1]
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0
Florida
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Minnesota
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Pennsylvania
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Country [4]
0
0
Brazil
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State/province [4]
0
0
São Paulo
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Country [5]
0
0
Canada
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State/province [5]
0
0
Quebec
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Country [6]
0
0
Germany
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State/province [6]
0
0
Aachen
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Funding & Sponsors
Primary sponsor type
Other
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Name
Monash University
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Address
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Country
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Other collaborator category [1]
0
0
Other
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Name [1]
0
0
University of Minnesota
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Address [1]
0
0
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Country [1]
0
0
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Other collaborator category [2]
0
0
Other
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Name [2]
0
0
RWTH Aachen University
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Address [2]
0
0
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Country [2]
0
0
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Other collaborator category [3]
0
0
Other
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Name [3]
0
0
University of Campinas, Brazil
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Address [3]
0
0
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Country [3]
0
0
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Other collaborator category [4]
0
0
Other
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Name [4]
0
0
Children's Hospital of Philadelphia
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Address [4]
0
0
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University of Florida
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Friedreich's Ataxia Research Alliance
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McGill University
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Ethics approval
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT04349514
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Trial related presentations / publications
Hernandez ALCC, Rezende TJR, Martinez ARM, de Brito MR, Franca MC Jr. Tract-Specific Spinal Cord Diffusion Tensor Imaging in Friedreich's Ataxia. Mov Disord. 2022 Feb;37(2):354-364. doi: 10.1002/mds.28841. Epub 2021 Oct 29.
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Public notes
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Contacts
Principal investigator
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Nellie Georgiou-Karistianis, PhD
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Monash University
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
It is recognised that this project will generate data that is of interest to the FA academic and bio-pharmaceutical, drug development community. All such data (de-identified) will be made available to third parties at the completion of the study after request, with approval from the TRACK-FA Steering Committee. Each site will be required to ensure that participants are consented in such a way that allows the sharing of de-identified data with the community in this manner.
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When will data be available (start and end dates)?
Data will become available after the conclusion of the TRACK-FA study. The study will be 5 years in duration and each academic site may have a slightly different start and end date.
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Available to whom?
Data access will be granted on a case-by-case basis after the study has been completed. The requesting party will be required to submit a formal request to the TRACK-FA Steering Committee outlining how the data is to be used and for what purpose.
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04349514