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Instrumented Data Exchange for Ataxia Study (IDEA)

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ClinicalTrials.gov Identifier: NCT04268147
Recruitment Status : Recruiting
First Posted : February 13, 2020
Last Update Posted : September 29, 2020
Sponsor:
Collaborators:
Pfizer
Biogen
APDM Wearable Technologies
Information provided by (Responsible Party):
University of Chicago

Tracking Information
First Submitted Date February 4, 2020
First Posted Date February 13, 2020
Last Update Posted Date September 29, 2020
Actual Study Start Date June 1, 2019
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 11, 2020)
  • iSARA [ Time Frame: 2 years ]
    measurements collected by wearable inertial sensors during instrumented Scale for the Assessment and Rating of Ataxia (iSARA)
  • SARA [ Time Frame: 2 years ]
    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
  • mFARS [ Time Frame: 2 years ]
    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
  • Daily Life (UChicago site ONLY) [ Time Frame: 2 weeks ]
    APDM SmartSox technology used to measure daily life activity(movement, falls, etc.) of all University of Chicago subjects
  • Ataxia App on Watch/iPhone [ Time Frame: 2 years ]
    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.
  • Patient-Reported Questionnaires of Health [ Time Frame: 2 years ]
    Activities, Balance, and Confidence (ABC) Questionnaire; EQ-5D-5L Health Questionnaire; Modified Fatigue Impact Scale (MFIS-5); Activities of Daily Living (ADLs)
  • Falls Questionnaire [ Time Frame: 2 years ]
    Automatic email sent out to subjects inquiring about any falls and near falls they have experienced during the past month
  • Functional Staging [ Time Frame: 2 years ]
    Clinician evaluates severity of ataxia symptoms.
  • Timed 25 Foot Walk [ Time Frame: 2 years ]
    Subjects walk for 25 feet, as quickly and safely as possible, while being timed
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Instrumented Data Exchange for Ataxia Study
Official Title APDM Instrumented Data Exchange for Ataxia (IDEA) Study
Brief 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population ataxia clinics
Condition
  • Spinocerebellar Ataxia Type 1
  • Spinocerebellar Ataxia Type 2
  • Spinocerebellar Ataxia Type 3
  • Spinocerebellar Ataxia Type 6
  • Friedreich Ataxia
Intervention Not Provided
Study Groups/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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 11, 2020)
144
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 30, 2022
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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 feet 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:

  • dementia that limits subjects' ability to follow directions
  • pain that limits mobility
  • SCA: enrolled in a clinical drug trial
Sex/Gender
Sexes Eligible for Study: All
Ages 12 Years to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Hannah Casey 7737024610 hannahcasey@uchicago.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04268147
Other Study ID Numbers IRB18-1580
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University of Chicago
Study Sponsor University of Chicago
Collaborators
  • Pfizer
  • Biogen
  • APDM Wearable Technologies
Investigators Not Provided
PRS Account University of Chicago
Verification Date September 2020