Instrumented Data Exchange for Ataxia Study (IDEA)

• ClinicalTrials.gov Identifier: NCT04268147
• Recruitment Status: Recruiting
• First Posted: February 13, 2020
• Last Update Posted: April 6, 2021
• Sponsor: University of Chicago
• 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: April 6, 2021
• 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
• 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

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

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: April 2021