Instrumented Data Exchange for Ataxia Study (IDEA)

APDM Instrumented Data Exchange for Ataxia (IDEA) Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Spinocerebellar Ataxia Type 3; Friedreich Ataxia; Spinocerebellar Ataxia Type 1; Spinocerebellar Ataxia Type 2; Spinocerebellar Ataxia Type 6

• Study Type: Observational
• Enrollment (Anticipated): 144

Contacts and Locations

• Study Contact: Name: Hannah Casey; Phone Number: 7737024610; Email: hannahcasey@uchicago.edu

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

ataxia clinics

Description

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:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

7

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
iSARA	measurements collected by wearable inertial sensors during instrumented Scale for the Assessment and Rating of Ataxia (iSARA)	2 years
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	2 years
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	2 years
Daily Life (UChicago site ONLY)	APDM SmartSox technology used to measure daily life activity(movement, falls, etc.) of all University of Chicago subjects	2 weeks
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.	2 years
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)	2 years
Falls Questionnaire	Automatic email sent out to subjects inquiring about any falls and near falls they have experienced during the past month	2 years
Functional Staging	Clinician evaluates severity of ataxia symptoms.	2 years
Timed 25 Foot Walk	Subjects walk for 25 feet, as quickly and safely as possible, while being timed	2 years

Collaborators and Investigators

• Sponsor: University of Chicago
• Collaborators: Pfizer; Biogen; APDM Wearable Technologies

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Anticipated): June 30, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: February 4, 2020
• First Submitted That Met QC Criteria: February 11, 2020
• First Posted (Actual): February 13, 2020

Study Record Updates

• Last Update Posted (Estimate): February 27, 2023
• Last Update Submitted That Met QC Criteria: February 24, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Genetic Diseases, Inborn; Neurodegenerative Diseases; Dyskinesias; Spinal Cord Diseases; Heredodegenerative Disorders, Nervous System; Mitochondrial Diseases; Cerebellar Diseases; Ataxia; Cerebellar Ataxia; Spinocerebellar Ataxias; Spinocerebellar Degenerations; Machado-Joseph Disease; Friedreich Ataxia
• Other Study ID Numbers: IRB18-1580

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No