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Completed

NCT Number: NCT04268147

Instrumented Data Exchange for Ataxia 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.

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Key information

Conditions

Spinocerebellar Ataxia Type 1 Ataxia Brain Diseases Central Nervous System Diseases Cerebellar Ataxia Cerebellar Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyskinesias Friedreich Ataxia Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Machado-Joseph Disease Metabolic Diseases Mitochondrial Diseases Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Spinal Cord Diseases Spinocerebellar Ataxia Type 2 Spinocerebellar Ataxia Type 3 Spinocerebellar Ataxia Type 6 Spinocerebellar Ataxias Spinocerebellar Degenerations

Age range

12 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California-Los Angeles, Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • APDM Wearable Technologies
  • Biogen
  • Pfizer

Registry information

Official study title

APDM Instrumented Data Exchange for Ataxia (IDEA) Study

Acronym: IDEA

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Feb 13, 2020
Registry last updated
Aug 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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