Instrumented Data Exchange for Ataxia Study

NCT04268147

Last updated date
Study Location
University of California-Los Angeles
Los Angeles, California, 90095, United States
Contact
7737024610

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Spinocerebellar Ataxia Type 1, Spinocerebellar Ataxia Type 2, Spinocerebellar Ataxia Type 3, Spinocerebellar Ataxia Type 6, Friedreich Ataxia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
12-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- dementia that limits subjects' ability to follow directions


- pain that limits mobility

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Spinocerebellar Ataxia Type 1, Spinocerebellar Ataxia Type 2, Spinocerebellar Ataxia Type 3, Spinocerebellar Ataxia Type 6, Friedreich AtaxiaInstrumented Data Exchange for Ataxia Study
NCT04268147
  1. Los Angeles, California
  2. Chicago, Illinois
  3. Baltimore, Maryland
  4. Boston, Massachusetts
ALL GENDERS
12 Years+
years
MULTIPLE SITES
Advanced Information
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
Sex/Gender
Sexes Eligible for Study:All
Ages 12 Years to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Hannah Casey7737024610[email protected]
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 February 2020