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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04349514




Registration number
NCT04349514
Ethics application status
Date submitted
1/04/2020
Date registered
16/04/2020
Date last updated
20/07/2020

Titles & IDs
Public title
A Natural History Study to TRACK Brain and Spinal Cord Changes in Individuals With Friedreich Ataxia (TRACK-FA)
Scientific title
A Natural History Study to TRACK Brain and Spinal Cord Changes in Individuals With Friedreich Ataxia (TRACK-FA)
Secondary ID [1] 0 0
TRACK-FA
Universal Trial Number (UTN)
Trial acronym
(TRACK-FA)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Friedreich Ataxia 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Neurological 0 0 0 0
Neurodegenerative diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Baseline dentate nuclei magnetic susceptibility - 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.
Timepoint [1] 0 0
Baseline
Primary outcome [2] 0 0
Slope of change in dentate nuclei magnetic susceptibility - 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.
Timepoint [2] 0 0
Baseline to 24 months
Primary outcome [3] 0 0
Baseline dentate volume - 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.
Timepoint [3] 0 0
Baseline
Primary outcome [4] 0 0
Slope of change in dentate volume - 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.
Timepoint [4] 0 0
Baseline to 24 months
Primary outcome [5] 0 0
Baseline total cerebellar volume - 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.
Timepoint [5] 0 0
Baseline
Primary outcome [6] 0 0
Slope of change in total cerebellar volume - 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.
Timepoint [6] 0 0
Baseline to 24 months
Primary outcome [7] 0 0
Baseline superior cerebellar peduncle volume - 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.
Timepoint [7] 0 0
Baseline
Primary outcome [8] 0 0
Slope of change in superior cerebellar peduncle volume - 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.
Timepoint [8] 0 0
Baseline to 24 months
Primary outcome [9] 0 0
Baseline superior cerebellar peduncle fractional anisotropy - 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.
Timepoint [9] 0 0
Baseline
Primary outcome [10] 0 0
Slope of change in superior cerebellar peduncle fractional anisotropy - 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.
Timepoint [10] 0 0
Baseline to 24 months
Primary outcome [11] 0 0
Baseline superior cerebellar peduncle mean diffusivity - 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.
Timepoint [11] 0 0
Baseline
Primary outcome [12] 0 0
Slope of change in superior cerebellar peduncle mean diffusivity - 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.
Timepoint [12] 0 0
Baseline to 24 months
Primary outcome [13] 0 0
Baseline superior cerebellar peduncle radial diffusivity - 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.
Timepoint [13] 0 0
Baseline
Primary outcome [14] 0 0
Slope of change in superior cerebellar peduncle radial diffusivity - 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.
Timepoint [14] 0 0
Baseline to 24 months
Primary outcome [15] 0 0
Baseline superior cerebellar peduncle axial diffusivity - 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.
Timepoint [15] 0 0
Baseline
Primary outcome [16] 0 0
Slope of change in superior cerebellar peduncle axial diffusivity - 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.
Timepoint [16] 0 0
Baseline to 24 months
Primary outcome [17] 0 0
Baseline cervical spinal cord cross-sectional area - 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.
Timepoint [17] 0 0
Baseline
Primary outcome [18] 0 0
Slope of change in cervical spinal cord cross-sectional area - 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.
Timepoint [18] 0 0
Baseline to 24 months
Primary outcome [19] 0 0
Baseline cervical spinal cord fractional anisotropy - 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.
Timepoint [19] 0 0
Baseline
Primary outcome [20] 0 0
Slope of change in cervical spinal cord fractional anisotropy - 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.
Timepoint [20] 0 0
Baseline to 24 months
Primary outcome [21] 0 0
Baseline cervical spinal cord mean diffusivity - 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.
Timepoint [21] 0 0
Baseline
Primary outcome [22] 0 0
Slope of change in cervical spinal cord mean diffusivity - 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.
Timepoint [22] 0 0
Baseline to 24 months
Primary outcome [23] 0 0
Baseline cervical spinal cord radial diffusivity - 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.
Timepoint [23] 0 0
Baseline
Primary outcome [24] 0 0
Slope of change in cervical spinal cord radial diffusivity - 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.
Timepoint [24] 0 0
Baseline to 24 months
Primary outcome [25] 0 0
Baseline cervical spinal cord axial diffusivity - 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.
Timepoint [25] 0 0
Baseline
Primary outcome [26] 0 0
Slope of change in cervical spinal cord axial diffusivity - 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.
Timepoint [26] 0 0
Baseline to 24 months
Primary outcome [27] 0 0
Baseline cervical spine tNAA/mIns ratio - 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.
Timepoint [27] 0 0
Baseline
Primary outcome [28] 0 0
Slope of the cervical spine tNAA/mIns ratio - 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.
Timepoint [28] 0 0
Baseline to 24 months
Secondary outcome [1] 0 0
Modified Friedreich Ataxia Rating Scale (mFARS) score - 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.
Timepoint [1] 0 0
Baseline to 24 months
Secondary outcome [2] 0 0
Upright Stability (US) score - 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.
Timepoint [2] 0 0
Baseline to 24 months
Secondary outcome [3] 0 0
Activities of Daily Living (ADL) score - 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.
Timepoint [3] 0 0
Baseline to 24 months
Secondary outcome [4] 0 0
Scale for the Assessment and Rating of Ataxia (SARA) score - 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.
Timepoint [4] 0 0
Baseline to 24 months
Secondary outcome [5] 0 0
9 Hole Peg Test times - 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.
Timepoint [5] 0 0
Baseline to 24 months
Secondary outcome [6] 0 0
Speech analysis scores - 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.
Timepoint [6] 0 0
Baseline to 24 months
Secondary outcome [7] 0 0
Low-Contrast Sloan Letter Chart (LCSLC) test score - 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.
Timepoint [7] 0 0
Baseline to 24 months
Secondary outcome [8] 0 0
Cerebellar Cognitive Affective/Schmahmann Syndrome (CCAS) scale score - 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.
Timepoint [8] 0 0
Baseline to 24 months
Secondary outcome [9] 0 0
Hayling Sentence Completion Test (HSCT) scores - 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.
Timepoint [9] 0 0
Baseline to 24 months
Secondary outcome [10] 0 0
Hospital Anxiety and Depression Scale (HADS) scores - 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.
Timepoint [10] 0 0
Baseline to 24 months
Secondary outcome [11] 0 0
Junior Hayling Sentence Completion Test (Junior HSCT) scores - 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.
Timepoint [11] 0 0
Baseline to 24 months
Secondary outcome [12] 0 0
Paediatric Cerebellar Cognitive Affective/Schmahmann Syndrome (CCAS) scale score - 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.
Timepoint [12] 0 0
Baseline to 24 months
Secondary outcome [13] 0 0
Revised Children's Anxiety and Depression scale (RCADS) scores - 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.
Timepoint [13] 0 0
Baseline to 24 months

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
Minimum age
5 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Biomedical Imaging, Monash University - Clayton
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Minnesota
Country [3] 0 0
United States of America
State/province [3] 0 0
Pennsylvania
Country [4] 0 0
Brazil
State/province [4] 0 0
São Paulo
Country [5] 0 0
Germany
State/province [5] 0 0
Aachen

Funding & Sponsors
Primary sponsor type
Other
Name
Monash University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Minnesota
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
RWTH Aachen University
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
University of Campinas, Brazil
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Children's Hospital of Philadelphia
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
University of Florida
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Friedreich's Ataxia Research Alliance
Address [6] 0 0
Country [6] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT04349514
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Nellie Georgiou-Karistianis, PhD
Address 0 0
Monash University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Nellie Georgiou-Karistianis, PhD
Address 0 0
Country 0 0
Phone 0 0
+ 61 3 9905 1575
Fax 0 0
Email 0 0
nellie.georgiou-karistianis@monash.edu
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04349514