Instrumented Data Exchange for Ataxia Study (IDEA)

The University of Chicago

Status: Completed

Conditions: Spinocerebellar Ataxia Type 6; Spinocerebellar Ataxia Type 2; Friedreich Ataxia; Spinocerebellar Ataxia Type 1; Spinocerebellar Ataxia Type 3

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04268147

IRB18-1580

Details and patient eligibility

About

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.

Enrollment: 128 patients

Sex: All

Ages: 12 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

128 participants in 7 patient groups

Spinocerebellar Ataxia-1

Description:

individuals with a genetically confirmed diagnosis of SCA-1

Spinocerebellar Ataxia-2

Description:

individuals with a genetically confirmed diagnosis of SCA-2

Spinocerebellar Ataxia-3

Description:

individuals with a genetically confirmed diagnosis of SCA-3

Spinocerebellar Ataxia-6

Description:

individuals with a genetically confirmed diagnosis of SCA-6

Freidreich's Ataxia

Description:

individuals with a genetically confirmed diagnosis of FA

FA Controls

Description:

Healthy, age-matched controls

SCA Controls

Description:

Healthy, age-matched controls