ClinicalTrials.gg
CompletedNCT04268147IDEAUpdated Aug 5, 2024

Instrumented Data Exchange for Ataxia Study

An observational study in Spinocerebellar Ataxia Type 1, Spinocerebellar Ataxia Type 2 and Spinocerebellar Ataxia Type 3, sponsored by University of Chicago. Completed at 5 sites in United States. Open to participants aged 12 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-05.

Sponsored by University of Chicago · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
128
Ages
12 Years to 75 Years
Sex
All
01

Study summary

This research study is testing body-worn sensors to measure movement during simple tests of coordination, in order to evaluate the progression and severity of ataxia.

02

Conditions studied

  • Spinocerebellar Ataxia Type 1
  • Spinocerebellar Ataxia Type 2
  • Spinocerebellar Ataxia Type 3
  • Spinocerebellar Ataxia Type 6
  • Friedreich Ataxia
03

In context

Spinocerebellar Ataxias

111 studies on the registry are indexed under Spinocerebellar Ataxias; 27 are open to participants now.

This study's enrollment of 128 is close to the median of 124 across 32 observational studies indexed under Spinocerebellar Ataxias.

Browse Spinocerebellar Ataxias studies →

Lead sponsor

University of Chicago is the lead sponsor of 924 studies on the registry; 185 are open to participants now.

Of its 102 completed or terminated interventional studies of FDA-regulated products, 71 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

ataxia clinics

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • SCA 1, 2, 3, 6, and FA with mutations in the pathogenic range confirmed from genetic testing
  • SCA: aged 18-75 years
  • FA: aged 12-30, diagnosed between ages 5-25
  • community dwelling
  • physically/cognitively capable of consenting/assenting and complying with the protocol based on investigator's judgement
  • able to walk independently 10 yards without an assistive device
  • able to sit or stand unassisted for 30 seconds
  • no other neurological or musculoskeletal disorder that could affect mobility
  • no other history of head injury, vestibular function, stroke, or other disorders that could affect mobility
  • willing and able to participate in a 2-year study
  • consent to be video recorded while performing study assessments

Exclusion criteria

Exclusion Criteria:

  • dementia that limits subjects' ability to follow directions
  • pain that limits mobility
  • SCA: enrolled in a clinical drug trial
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
128 participants (actual)
Patient registry
No

Groups and cohorts

  • Spinocerebellar Ataxia-1

    individuals with a genetically confirmed diagnosis of SCA-1

  • Spinocerebellar Ataxia-2

    individuals with a genetically confirmed diagnosis of SCA-2

  • Spinocerebellar Ataxia-3

    individuals with a genetically confirmed diagnosis of SCA-3

  • Spinocerebellar Ataxia-6

    individuals with a genetically confirmed diagnosis of SCA-6

  • Freidreich's Ataxia

    individuals with a genetically confirmed diagnosis of FA

  • FA Controls

    Healthy, age-matched controls

  • SCA Controls

    Healthy, age-matched controls

06

What researchers measure

Primary outcomes

  1. iSARA

    measurements collected by wearable inertial sensors during instrumented Scale for the Assessment and Rating of Ataxia (iSARA)

    Time frame: 2 years

  2. SARA

    Scale for the Assessment and Rating of Ataxia (SARA) measurements evaluated by clinician to measure severity of spinocerebellar ataxia through coordination, speech, stance, and gait

    Time frame: 2 years

  3. mFARS

    modified Friedreich's Ataxia Rating Scale (mFARS) measurements evaluated by clinician compared to measure severity of Friedreich's ataxia through coordination, speech, stance, and gait

    Time frame: 2 years

  4. Daily Life (UChicago site ONLY)

    APDM SmartSox technology used to measure daily life activity(movement, falls, etc.) of all University of Chicago subjects

    Time frame: 2 weeks

  5. Ataxia App on Watch/iPhone

    Bi-weekly assessments completed on Ataxia Application for Apple Watches and iPhones. Data collected includes active monitoring of speech, stance, coordination, gait and patient-reported symptoms.

    Time frame: 2 years

  6. Patient-Reported Questionnaires of Health

    Activities, Balance, and Confidence (ABC) Questionnaire; EQ-5D-5L Health Questionnaire; Modified Fatigue Impact Scale (MFIS-5); Activities of Daily Living (ADLs)

    Time frame: 2 years

  7. Falls Questionnaire

    Automatic email sent out to subjects inquiring about any falls and near falls they have experienced during the past month

    Time frame: 2 years

  8. Functional Staging

    Clinician evaluates severity of ataxia symptoms.

    Time frame: 2 years

  9. Timed 25 Foot Walk

    Subjects walk for 25 feet, as quickly and safely as possible, while being timed

    Time frame: 2 years

07

Study locations

5 sites
  • University of California-Los Angeles
    Los Angeles, California 90095, United States
  • The University of Chicago
    Chicago, Illinois 60637, United States
  • Johns Hopkins Medicine
    Baltimore, Maryland 21231, United States
  • Mass General Hospital
    Boston, Massachusetts 02114, United States
  • Oregon Health & Science University
    Portland, Oregon 97239, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2019 to primary completion in Apr 2024, 58 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 4, 2020
First posted
Feb 13, 2020
StartActual
Jun 1, 2019
Primary completionActual
Apr 30, 2024
CompletionActual
Jun 30, 2024
Last update
Aug 5, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04268147
Collaborators
Pfizer, Biogen, APDM Wearable Technologies
Responsible party
Sponsor
First posted
Feb 13, 2020
Start date
Jun 1, 2019
Primary completion
Apr 30, 2024
Completion
Jun 30, 2024
Last update
Aug 5, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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