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Instrumented Data Exchange for Ataxia Study (IDEA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.

Condition or disease
Spinocerebellar Ataxia Type 1 Spinocerebellar Ataxia Type 2 Spinocerebellar Ataxia Type 3 Spinocerebellar Ataxia Type 6 Friedreich Ataxia

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Study Type : Observational
Estimated Enrollment : 144 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: APDM Instrumented Data Exchange for Ataxia (IDEA) Study
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : June 30, 2022


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



Primary Outcome Measures :
  1. iSARA [ Time Frame: 2 years ]
    measurements collected by wearable inertial sensors during instrumented Scale for the Assessment and Rating of Ataxia (iSARA)

  2. 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

  3. 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

  4. 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

  5. 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.

  6. 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)

  7. 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

  8. Functional Staging [ Time Frame: 2 years ]
    Clinician evaluates severity of ataxia symptoms.

  9. Timed 25 Foot Walk [ Time Frame: 2 years ]
    Subjects walk for 25 feet, as quickly and safely as possible, while being timed



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
ataxia clinics
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04268147


Contacts
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Contact: Hannah Casey 7737024610 hannahcasey@uchicago.edu

Locations
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United States, California
University of California-Los Angeles Not yet recruiting
Los Angeles, California, United States, 90095
Contact: Aaron Fisher       adfisher@mednet.ucla.edu   
Principal Investigator: Susan Perlman, MD         
United States, Illinois
The University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Hannah Casey    773-702-4610    hannahcasey@uchicago.edu   
Principal Investigator: Christopher Gomez, MD, PhD         
United States, Maryland
Johns Hopkins Medicine Recruiting
Baltimore, Maryland, United States, 21231
Contact: Katherine Iannuzzelli       kiannuz1@jhmi.edu   
Principal Investigator: Liana Rosenthal, MD         
United States, Massachusetts
Mass General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Jason Macmore       jmacmore@mgh.harvard.edu   
Principal Investigator: Jeremy Schmahmann, MD         
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Patty Carlson-Kuhta       carlsonp@ohsu.edu   
Principal Investigator: Delaram Safarpour, MD         
Sponsors and Collaborators
University of Chicago
Pfizer
Biogen
APDM Wearable Technologies
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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT04268147    
Other Study ID Numbers: IRB18-1580
First Posted: February 13, 2020    Key Record Dates
Last Update Posted: September 29, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ataxia
Cerebellar Ataxia
Spinocerebellar Ataxias
Spinocerebellar Degenerations
Friedreich Ataxia
Machado-Joseph Disease
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Cerebellar Diseases
Brain Diseases
Central Nervous System Diseases
Spinal Cord Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Mitochondrial Diseases
Metabolic Diseases